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\\begin{tabular}{l}\nSponsor: \\\\\nPromedior, Inc\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nName of Finished Product: \\\\\nRecombinant human Pentraxin-2; PRM-151\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nStudy Title: \\\\\nA Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects with Idiopathic Pulmonary Fibrosis (IPF)\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nStudy Number: \\\\\nPRM-151-202\n\\end{tabular} \\\\\n\\hline Study Phase: Phase 2 \\\\\n\\hline \\begin{tabular}{l}\nInvestigational Product; Dose; and Mode of Administration: \\\\\nPRM-151 \\(10 mg / kg\\) every 4 weeks via intravenous infusion over 60 minutes. \\\\\nOn all dosing days, dosing will occur after all safety and efficacy assessments scheduled for that visit are completed.\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nComparator Dose; and Mode of Administration: \\\\\nPlacebo will be administered via IV infusion over 60 minutes.\n\\end{tabular} \\\\\n\\hline 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Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in normal lung parenchyma as quantified on HRCT imaging analysis, separately in subjects on a stable dose of pirfenidone or nintedanib and in subjects not on other treatments for IPF. \\\\\n- Assess the tolerability and safety of PRM-151 in subjects with IPF through Week 28 \\\\\n- Assess the ability of PRM-151 to reduce disease-related events associated with mortality. \\\\\n- Determine the effect size of PRM-151 relative to placebo on pulmonary function in addition to mean change in FVC\\% predicted. \\\\\n- Determine the effect size of PRM-151 relative to placebo on 6 -minute walk distance. \\\\\n- Assess the effect size of PRM-151 relative to placebo on Hb-corrected 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Subject is aged \\(40-80\\) years.","text_display":"\n1. Subject is aged \\(40-80\\) years.","confidence":0.9443359375,"confidence_rate":0.9985325313726232},{"cnt":[[438,1788],[1835,1788],[1835,1837],[438,1837]],"region":{"top_left_x":438,"top_left_y":1787,"width":1397,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4d0aec84169b4384a472e710afba0dee","type":"text","conversion_output":true,"text":"2. Subject has IPF satisfying the ATS/ERS/JRS/ALAT diagnostic criteria (Raghu,","text_display":"\n2. Subject has IPF satisfying the ATS/ERS/JRS/ALAT diagnostic criteria (Raghu,","confidence":1,"confidence_rate":1},{"cnt":[[501,1835],[844,1835],[844,1884],[501,1884]],"region":{"top_left_x":500,"top_left_y":1834,"width":345,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4056d0ed78b64a0e8fcd10b877a2d0eb","type":"text","conversion_output":true,"text":"Collard et al. 2011).","text_display":" Collard et al. 2011).","confidence":0.99951171875,"confidence_rate":0.9999812155418875},{"cnt":[[516,1882],[1835,1882],[1835,1931],[516,1931]],"region":{"top_left_x":515,"top_left_y":1882,"width":1320,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4b53bf0fb46d451d840864f4c76884eb","type":"text","conversion_output":true,"text":"In the absence of a surgical lung biopsy, HRCT must be \"consistent with UIP\"","text_display":"\nIn the absence of a surgical lung biopsy, HRCT must be \"consistent with UIP\"","confidence":1,"confidence_rate":1},{"cnt":[[516,1929],[1910,1929],[1910,1981],[516,1981]],"region":{"top_left_x":515,"top_left_y":1929,"width":1395,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"411786e0c8f246fea7df27c528af7c20","type":"text","conversion_output":true,"text":"defined as meeting either criteria \\(A , B\\), and C , or criteria A and C , or criteria B and","text_display":" defined as meeting either criteria \\(A , B\\), and C , or criteria A and C , or criteria B and","confidence":1,"confidence_rate":1},{"cnt":[[516,1977],[677,1977],[677,2022],[516,2022]],"region":{"top_left_x":515,"top_left_y":1976,"width":162,"height":46},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4c6027f3dc24f9bbf2e98e4713c7ae6","type":"text","conversion_output":true,"text":"C below:","text_display":" C below:","confidence":1,"confidence_rate":1},{"cnt":[[578,2024],[1704,2024],[1704,2075],[578,2075]],"region":{"top_left_x":577,"top_left_y":2023,"width":1127,"height":53},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07fdb5e23f0d4d44bc4957f8ce8587a0","type":"text","conversion_output":true,"text":"A. Definite honeycomb lung destruction with basal and peripheral","text_display":"\nA. Definite honeycomb lung destruction with basal and peripheral","confidence":1,"confidence_rate":1},{"cnt":[[640,2075],[896,2075],[896,2125],[640,2125]],"region":{"top_left_x":640,"top_left_y":2075,"width":256,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c6351a9706204f1da76a0b440f61855d","type":"text","conversion_output":true,"text":"predominance.","text_display":" predominance.","confidence":1,"confidence_rate":1},{"cnt":[[580,2123],[1869,2123],[1869,2172],[580,2172]],"region":{"top_left_x":580,"top_left_y":2122,"width":1290,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51fa755d07be45bc9d3dfbb8c7bb2638","type":"text","conversion_output":true,"text":"B. Presence of reticular abnormality AND traction bronchiectasis consistent","text_display":"\nB. Presence of reticular abnormality AND traction bronchiectasis consistent","confidence":1,"confidence_rate":1},{"cnt":[[640,2170],[1555,2170],[1555,2219],[640,2219]],"region":{"top_left_x":640,"top_left_y":2169,"width":916,"height":51},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"578bc34f03bc48ba8c9e0321549194d0","type":"text","conversion_output":true,"text":"with fibrosis, with basal and peripheral predominance.","text_display":" with fibrosis, with basal and peripheral predominance.","confidence":1,"confidence_rate":1},{"cnt":[[580,2217],[1781,2217],[1781,2267],[580,2267]],"region":{"top_left_x":580,"top_left_y":2217,"width":1202,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87a07061ed904fbca43e3b888a3dc27a","type":"text","conversion_output":true,"text":"C. Atypical features are absent, specifically nodules and consolidation.","text_display":"\nC. 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If on pirfenidone or nintedanib, subject must have been on a stable dose of","text_display":"\n3. If on pirfenidone or nintedanib, subject must have been on a stable dose of","confidence":1,"confidence_rate":1},{"cnt":[[501,2411],[1916,2411],[1916,2460],[501,2460]],"region":{"top_left_x":500,"top_left_y":2410,"width":1417,"height":50},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53b70eaf6c594076a48882ec58b42324","type":"text","conversion_output":true,"text":"pirfenidone or nintedanib for at least 3 months prior to screening without increase in","text_display":" pirfenidone or nintedanib for at least 3 months prior to screening without increase in","confidence":0.99755859375,"confidence_rate":0.9999739961748949},{"cnt":[[1053,2557],[1079,2557],[1079,2593],[1053,2593]],"region":{"top_left_x":1052,"top_left_y":2556,"width":27,"height":38},"line":51,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6f6a3bffe1b84c4e8896d4b95d562114","type":"page_info","conversion_output":false,"text":"6","text_display":"","confidence":0.99853515625,"confidence_rate":0.99853515625}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"05532668-04bd-4780-8ef0-43abd30e1f06-07","page":7,"lines":[{"cnt":[[305,133],[453,133],[453,174],[305,174]],"region":{"top_left_x":305,"top_left_y":133,"width":149,"height":42},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"42d13bda755a4828a41ed1db669ad5aa","type":"page_info","conversion_output":false,"text":"PRM-151","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,185],[733,185],[733,230],[305,230]],"region":{"top_left_x":305,"top_left_y":184,"width":428,"height":46},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e91232b27ee44720b2890bf565130991","type":"page_info","conversion_output":false,"text":"Study Protocol PRM-151-202","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1646,185],[1824,185],[1824,230],[1646,230]],"region":{"top_left_x":1645,"top_left_y":184,"width":180,"height":46},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6d605e5df43145f58ff48f26a0fa4a04","type":"page_info","conversion_output":false,"text":"Version 4.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[498,284],[1914,284],[1914,337],[498,337]],"region":{"top_left_x":498,"top_left_y":283,"width":1417,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f55c044adb24f6593e0fecf2cde362d","type":"text","conversion_output":true,"text":"FVC\\% predicted on two consecutive PFTs, including screening PFTs. Subjects may","text_display":"\n\nFVC\\% predicted on two consecutive PFTs, including screening PFTs. Subjects may","confidence":0.99951171875,"confidence_rate":0.999994115673962},{"cnt":[[498,335],[1218,335],[1218,385],[498,385]],"region":{"top_left_x":498,"top_left_y":335,"width":721,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d282178540a745e7bc1b1a4357a15e08","type":"text","conversion_output":true,"text":"not be on both pirfenidone and nintedanib.","text_display":" not be on both pirfenidone and nintedanib.","confidence":1,"confidence_rate":1},{"cnt":[[434,382],[1835,382],[1835,432],[434,432]],"region":{"top_left_x":433,"top_left_y":382,"width":1402,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48d95632d76a44c99caaa75b227e4e06","type":"text","conversion_output":true,"text":"4. If not currently receiving pirfenidone or nintedanib, subject must have been off","text_display":"\n4. 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Women of child bearing potential (WCBP), defined as a sexually mature woman not","text_display":"\n9. 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The primary endpoint will be tested with analysis of variance (ANOVA), with","text_display":" alpha \\(=0.10\\). 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A by-subject AE data listing including onset and","text_display":" and the number of subjects with any AE. A by-subject AE data listing including onset and","confidence":1,"confidence_rate":1},{"cnt":[[329,1027],[1884,1027],[1884,1076],[329,1076]],"region":{"top_left_x":328,"top_left_y":1026,"width":1557,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caf0c3b037264f99b1a88d41e7e8bc04","type":"text","conversion_output":true,"text":"resolution dates, verbatim term, preferred term, treatment, severity, relationship to treatment,","text_display":" resolution dates, verbatim term, preferred term, treatment, severity, relationship to treatment,","confidence":1,"confidence_rate":1},{"cnt":[[331,1074],[1068,1074],[1068,1124],[331,1124]],"region":{"top_left_x":330,"top_left_y":1074,"width":738,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7767c718568543f5a47f035b9de41e9c","type":"text","conversion_output":true,"text":"action taken, and outcome will be provided.","text_display":" action taken, and outcome will be provided.","confidence":1,"confidence_rate":1},{"cnt":[[331,1171],[1897,1171],[1897,1222],[331,1222]],"region":{"top_left_x":330,"top_left_y":1170,"width":1568,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b68176a99c9c47e28ed26a354448729e","type":"text","conversion_output":true,"text":"Safety data, including laboratory evaluations and vital signs assessments, will be summarized","text_display":"\n\nSafety data, including laboratory evaluations and vital signs assessments, will be summarized","confidence":1,"confidence_rate":1},{"cnt":[[331,1220],[1794,1220],[1794,1270],[331,1270]],"region":{"top_left_x":330,"top_left_y":1220,"width":1464,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5fa172c69178427192a9652de352ee5c","type":"text","conversion_output":true,"text":"by time of collection and by treatment group. In addition, change from Baseline to any","text_display":" by time of collection and by treatment group. In addition, change from Baseline to any","confidence":1,"confidence_rate":1},{"cnt":[[329,1268],[1794,1268],[1794,1317],[329,1317]],"region":{"top_left_x":328,"top_left_y":1267,"width":1466,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f33c34a802774f29abdd294aaff9520a","type":"text","conversion_output":true,"text":"post-dose values will be summarized for vital signs and clinical laboratory results. The","text_display":" post-dose values will be summarized for vital signs and clinical laboratory results. The","confidence":1,"confidence_rate":1},{"cnt":[[331,1315],[1871,1315],[1871,1364],[331,1364]],"region":{"top_left_x":330,"top_left_y":1314,"width":1542,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ca7b384be5d49a6b6d957627621b9c4","type":"text","conversion_output":true,"text":"frequency of subjects with abnormal safety laboratory results will be tabulated by treatment.","text_display":" frequency of subjects with abnormal safety laboratory results will be tabulated by treatment.","confidence":1,"confidence_rate":1},{"cnt":[[322,1420],[846,1420],[846,1480],[322,1480]],"region":{"top_left_x":322,"top_left_y":1420,"width":525,"height":61},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7418c15f8df74fbfb6ffc4f985656a72","type":"section_header","conversion_output":false,"children_ids":["f4d7270f4c534944ad0720eb1fb77b6d"],"text":"","text_display":""},{"cnt":[[327,1427],[840,1427],[840,1476],[327,1476]],"region":{"top_left_x":326,"top_left_y":1426,"width":515,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4d7270f4c534944ad0720eb1fb77b6d","type":"text","conversion_output":true,"parent_id":"7418c15f8df74fbfb6ffc4f985656a72","text":"Sample Size Considerations:","text_display":"\n\n\\section*{Sample Size Considerations:}","confidence":1,"confidence_rate":1},{"cnt":[[327,1474],[1777,1474],[1777,1523],[327,1523]],"region":{"top_left_x":326,"top_left_y":1473,"width":1451,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79717dafc92641fc8fb98f4b3addcb09","type":"text","conversion_output":true,"text":"The primary objective is not to formally demonstrate the superiority of PRM-151 over","text_display":"\n\nThe primary objective is not to formally demonstrate the superiority of PRM-151 over","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[327,1521],[1919,1521],[1919,1571],[327,1571]],"region":{"top_left_x":326,"top_left_y":1521,"width":1593,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a63d628515e447d92eeedf0a761a773","type":"text","conversion_output":true,"text":"placebo, but to provide a reliable estimate of the size of the effect of PRM-151 on change from","text_display":" placebo, but to provide a reliable estimate of the size of the effect of PRM-151 on change from","confidence":1,"confidence_rate":1},{"cnt":[[329,1568],[1884,1568],[1884,1618],[329,1618]],"region":{"top_left_x":328,"top_left_y":1568,"width":1557,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"239974a9736c4a11b90bcb556627849d","type":"text","conversion_output":true,"text":"baseline to 28 weeks in mean FVC\\% predicted, hereafter referred to as the primary endpoint.","text_display":" baseline to 28 weeks in mean FVC\\% predicted, hereafter referred to as the primary endpoint.","confidence":1,"confidence_rate":1},{"cnt":[[327,1616],[1893,1616],[1893,1665],[327,1665]],"region":{"top_left_x":326,"top_left_y":1615,"width":1567,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ca747030e9d4f259b0bff5152db548e","type":"text","conversion_output":true,"text":"Nevertheless, the sample-size has been calculated to ensure a sufficient power to demonstrate","text_display":" Nevertheless, the sample-size has been calculated to ensure a sufficient power to demonstrate","confidence":0.9990236759185791,"confidence_rate":0.9999900326925697},{"cnt":[[327,1663],[1871,1663],[1871,1712],[327,1712]],"region":{"top_left_x":326,"top_left_y":1662,"width":1546,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41a01ee6543442aab76e6e94b0ba68bd","type":"text","conversion_output":true,"text":"the efficacy of PRM-151 over placebo on the primary endpoint under a set of hypotheses on","text_display":" the efficacy of PRM-151 over placebo on the primary endpoint under a set of hypotheses on","confidence":0.99755859375,"confidence_rate":0.9999739961748949},{"cnt":[[329,1712],[1824,1712],[1824,1762],[329,1762]],"region":{"top_left_x":328,"top_left_y":1712,"width":1497,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d577808af17453e956f7e5064602a4c","type":"text","conversion_output":true,"text":"effect sizes in the two groups and on the variability of the primary endpoint. 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Abbreviation & Term \\\\\n\\hline 6MWD & 6-Minute walk distance \\\\\n\\hline 6MWT & Six-minute walk test \\\\\n\\hline ADL & Activities of daily living \\\\\n\\hline ADA & Anti-Drug Antibodies/Anti-Pentraxin 2 antibodies \\\\\n\\hline ADR & Adverse drug reaction \\\\\n\\hline AE & Adverse event \\\\\n\\hline AESI & Adverse Event of Special Interest \\\\\n\\hline ALAT & Latin American Thoracic Association \\\\\n\\hline ALK & Alkaline phosphatase \\\\\n\\hline ALT & Alanine aminotransferase \\\\\n\\hline AST & Aspartate aminotransferase \\\\\n\\hline ATS & American Thoracic Society \\\\\n\\hline \\(AUC _{0-24}\\) & Area under the curve from time 0 to 24 hours \\\\\n\\hline \\(AUC _{0-\\infty}\\) & Area under the curve from time 0 extrapolated to infinity \\\\\n\\hline BAL & Bronchoalveolar lavage \\\\\n\\hline BID & Twice daily \\\\\n\\hline BRT & Bronchodilator reversibility testing \\\\\n\\hline BUN & Blood urea nitrogen \\\\\n\\hline CFR & Code of Federal Regulations \\\\\n\\hline CRA & Clinical Research Associate \\\\\n\\hline CTGF & Connective tissue growth factor \\\\\n\\hline DLco & Diffusion Capacity of Carbon Monoxide \\\\\n\\hline DMC & Data Monitoring Committee \\\\\n\\hline DSUR & Development Safety Update Report \\\\\n\\hline EC & Ethics Committee \\\\\n\\hline ECM & Extracellular matrix \\\\\n\\hline eCRF & Electronic case report form \\\\\n\\hline ERS & European Respiratory Society \\\\\n\\hline EU & European Union \\\\\n\\hline FDA & Food and Drug Administration \\\\\n\\hline \\(FEV _{1}\\) & Forced expiratory volume in 1 second \\\\\n\\hline FVC & Forced vital capacity \\\\\n\\hline GCP & Good Clinical Practice \\\\\n\\hline hPTX-2 & Human pentraxin-2 \\\\\n\\hline HRCT & High-resolution computed tomography \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Abbreviation & Term \\\\\n\\hline 6MWD & 6-Minute walk distance \\\\\n\\hline 6MWT & Six-minute walk test \\\\\n\\hline ADL & Activities of daily living 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Abbreviation & Term \\\\\n\\hline hSAP & Human serum amyloid P(synonymous with hPTX-2) \\\\\n\\hline IC & Inspiratory capacity \\\\\n\\hline ICAM-1 & Intercellular adhesion molecule-1 \\\\\n\\hline ICF & Informed Consent Form \\\\\n\\hline ICH & International Conference on Harmonisation \\\\\n\\hline IL & Interleukin \\\\\n\\hline ILA & Interstitial Lung Abnormality \\\\\n\\hline ILD & Interstitial Lung Disease \\\\\n\\hline IND & Investigational New Drug Application \\\\\n\\hline IPF & Idiopathic pulmonary fibrosis \\\\\n\\hline IRB & Institutional Review Board \\\\\n\\hline IV & Intravenous \\\\\n\\hline JRS & Japanese Respiratory Society \\\\\n\\hline LAA & Low Attenuatino Areas \\\\\n\\hline LOXL2 & Lysyl oxidase-like 2 protein \\\\\n\\hline MedDRA & Medical Dictionary for Regulatory Activities \\\\\n\\hline MF & Myelofibrosis \\\\\n\\hline Mreg & Regulatory macrophages \\\\\n\\hline mRNA & Messenger ribonucleic acid \\\\\n\\hline \\(O _{2}\\) & Oxygen \\\\\n\\hline PDGF & 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& International Conference on Harmonisation \\\\\n\\hline IL & Interleukin \\\\\n\\hline ILA & Interstitial Lung Abnormality \\\\\n\\hline ILD & Interstitial Lung Disease \\\\\n\\hline IND & Investigational New Drug Application \\\\\n\\hline IPF & Idiopathic pulmonary fibrosis \\\\\n\\hline IRB & Institutional Review Board \\\\\n\\hline IV & Intravenous \\\\\n\\hline JRS & Japanese Respiratory Society \\\\\n\\hline LAA & Low Attenuatino Areas \\\\\n\\hline LOXL2 & Lysyl oxidase-like 2 protein \\\\\n\\hline MedDRA & Medical Dictionary for Regulatory Activities \\\\\n\\hline MF & Myelofibrosis \\\\\n\\hline Mreg & Regulatory macrophages \\\\\n\\hline mRNA & Messenger ribonucleic acid \\\\\n\\hline \\(O _{2}\\) & Oxygen \\\\\n\\hline PDGF & Platelet-derived growth factor \\\\\n\\hline PFT & Pulmonary function test \\\\\n\\hline PK & Pharmacokinetics \\\\\n\\hline pp & Percentage points \\\\\n\\hline PRO & Patient Reported Outcome \\\\\n\\hline PTX-2 & Pentraxin-2 \\\\\n\\hline q2w & Every 2 weeks \\\\\n\\hline q4w & Every 4 weeks \\\\\n\\hline RBC & Red blood cell \\\\\n\\hline SABA & Short-acting beta agonist \\\\\n\\hline SAE & Serious adverse event \\\\\n\\hline SAP & Serum amyloid protein, also \\\\\n\\hline & Statistical Analysis Plan \\\\\n\\hline SD & Standard deviation \\\\\n\\hline SD-SOBQ & San Diego-Shortness of Breath Questionnaire \\\\\n\\hline SGRQ & St. George Respiratory Questionnaire 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INTRODUCTION AND STUDY RATIONALE","text_display":"\n\n\\section*{1. INTRODUCTION AND STUDY RATIONALE}","confidence":1,"confidence_rate":1},{"cnt":[[305,357],[1154,357],[1154,419],[305,419]],"region":{"top_left_x":305,"top_left_y":356,"width":849,"height":63},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8556b563d4e24a5aac89915ec811e1c2","type":"section_header","conversion_output":false,"children_ids":["39f38ba2d76e4b6a82b50acdb23f70ee"],"text":"","text_display":""},{"cnt":[[309,357],[1149,357],[1149,415],[309,415]],"region":{"top_left_x":309,"top_left_y":356,"width":841,"height":59},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39f38ba2d76e4b6a82b50acdb23f70ee","type":"text","conversion_output":true,"parent_id":"8556b563d4e24a5aac89915ec811e1c2","text":"1.1. Idiopathic Pulmonary Fibrosis","text_display":"\n\n\\subsection*{1.1. Idiopathic Pulmonary Fibrosis}","confidence":0.97705078125,"confidence_rate":0.9994048783968003},{"cnt":[[305,434],[1656,434],[1656,486],[305,486]],"region":{"top_left_x":305,"top_left_y":433,"width":1352,"height":53},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9217fcf20606484782b4360dc557443a","type":"text","conversion_output":true,"text":"Idiopathic pulmonary fibrosis (IPF) is a rare, specific form of chronic, fibrosing,","text_display":"\n\nIdiopathic pulmonary fibrosis (IPF) is a rare, specific form of chronic, fibrosing,","confidence":1,"confidence_rate":1},{"cnt":[[305,488],[1781,488],[1781,537],[305,537]],"region":{"top_left_x":305,"top_left_y":487,"width":1477,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f740244a46e347b286c29a04d3cc2c00","type":"text","conversion_output":true,"text":"interstitial pneumonia limited to the lung. In the United States (US), IPF is estimated to","text_display":" interstitial pneumonia limited to the lung. In the United States (US), IPF is estimated to","confidence":1,"confidence_rate":1},{"cnt":[[305,541],[1699,541],[1699,591],[305,591]],"region":{"top_left_x":305,"top_left_y":541,"width":1395,"height":50},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac8bfc0abc7e413f9d931b7f4a9ffd3a","type":"text","conversion_output":true,"text":"affect up to 135,000 individuals, with approximately 50,000 cases being diagnosed","text_display":" affect up to 135,000 individuals, with approximately 50,000 cases being diagnosed","confidence":0.7889833450317383,"confidence_rate":0.9974271191622405},{"cnt":[[305,593],[1760,593],[1760,642],[305,642]],"region":{"top_left_x":305,"top_left_y":592,"width":1455,"height":51},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b4bc5ea60c244730bc61cd496c9ed5ae","type":"text","conversion_output":true,"text":"annually (Raghu, Weycker et al. 2006). It is estimated that each year, 40,000 people in","text_display":" annually (Raghu, Weycker et al. 2006). It is estimated that each year, 40,000 people in","confidence":0.9960954189300537,"confidence_rate":0.9999588195442787},{"cnt":[[305,645],[1809,645],[1809,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1504,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f9c18c67b3d40b4bc957d3880242f72","type":"text","conversion_output":true,"text":"the US die due to IPF or complications thereof (Raghu, Weycker et al. 2006), the same as","text_display":" the US die due to IPF or complications thereof (Raghu, Weycker et al. 2006), the same as","confidence":1,"confidence_rate":1},{"cnt":[[305,696],[1807,696],[1807,746],[305,746]],"region":{"top_left_x":305,"top_left_y":696,"width":1502,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6dd6d544aa6b428facf0e89d5dec7ea6","type":"text","conversion_output":true,"text":"for breast cancer. There is limited information regarding the incidence and prevalence of","text_display":" for breast cancer. There is limited information regarding the incidence and prevalence of","confidence":1,"confidence_rate":1},{"cnt":[[305,748],[1764,748],[1764,797],[305,797]],"region":{"top_left_x":305,"top_left_y":747,"width":1459,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56018c120fc5473c9f67a96a86d71bf4","type":"text","conversion_output":true,"text":"IPF in the European Union (EU); however, it is estimated that up to 40,000 individuals","text_display":" IPF in the European Union (EU); however, it is estimated that up to 40,000 individuals","confidence":0.99658203125,"confidence_rate":0.9999635770106784},{"cnt":[[305,799],[1738,799],[1738,849],[305,849]],"region":{"top_left_x":305,"top_left_y":799,"width":1434,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf328eb8a8764995bde771c584b39736","type":"text","conversion_output":true,"text":"are affected, with 5,000 cases diagnosed annually in the United Kingdom (UK) alone","text_display":" are affected, with 5,000 cases diagnosed annually in the United Kingdom (UK) alone","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[305,853],[1777,853],[1777,902],[305,902]],"region":{"top_left_x":305,"top_left_y":852,"width":1472,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ffd542d2f014681b4a92d870a737ba9","type":"text","conversion_output":true,"text":"(Navaratnam, Fleming et al. 2011). IPF incidence and prevalence increase with age and","text_display":" (Navaratnam, Fleming et al. 2011). IPF incidence and prevalence increase with age and","confidence":1,"confidence_rate":1},{"cnt":[[305,904],[1794,904],[1794,954],[305,954]],"region":{"top_left_x":305,"top_left_y":904,"width":1489,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"925228cf8a674ef29c1db07a7a043bbb","type":"text","conversion_output":true,"text":"are higher among males (Nalysnyk, Cid-Ruzafa et al. 2012). Overall, it is estimated that","text_display":" are higher among males (Nalysnyk, Cid-Ruzafa et al. 2012). Overall, it is estimated that","confidence":1,"confidence_rate":1},{"cnt":[[305,956],[1764,956],[1764,1008],[305,1008]],"region":{"top_left_x":305,"top_left_y":956,"width":1459,"height":52},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0b48f1bcd674e9f88294f1f95684b0a","type":"text","conversion_output":true,"text":"worldwide, 5 million individuals may be affected(Meltzer and Noble 2008). Although","text_display":" worldwide, 5 million individuals may be affected(Meltzer and Noble 2008). Although","confidence":1,"confidence_rate":1},{"cnt":[[305,1010],[1772,1010],[1772,1059],[305,1059]],"region":{"top_left_x":305,"top_left_y":1009,"width":1468,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa3cb0dcbb2e4337a4c54c3128b22a96","type":"text","conversion_output":true,"text":"rare, the incidence of IPF is increasing, likely due to an increasing understanding of the","text_display":" rare, the incidence of IPF is increasing, likely due to an increasing understanding of the","confidence":1,"confidence_rate":1},{"cnt":[[305,1061],[1803,1061],[1803,1111],[305,1111]],"region":{"top_left_x":305,"top_left_y":1061,"width":1498,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8fb2d3dce3ad4548b81147371f845db0","type":"text","conversion_output":true,"text":"disease and the recent development of uniform diagnostic criteria (Nalysnyk, Cid-Ruzafa","text_display":" disease and the recent development of uniform diagnostic criteria (Nalysnyk, Cid-Ruzafa","confidence":1,"confidence_rate":1},{"cnt":[[305,1113],[505,1113],[505,1162],[305,1162]],"region":{"top_left_x":305,"top_left_y":1112,"width":200,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed18398deb4e45a1aa349901ea7c40eb","type":"text","conversion_output":true,"text":"et al. 2012)","text_display":" et al. 2012)","confidence":1,"confidence_rate":1},{"cnt":[[305,1186],[1669,1186],[1669,1235],[305,1235]],"region":{"top_left_x":305,"top_left_y":1185,"width":1365,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4aa5eaea00c849b791f8fabcab44f4ab","type":"text","conversion_output":true,"text":"IPF is a progressive disease with significant morbidity and mortality. The precise","text_display":"\n\nIPF is a progressive disease with significant morbidity and mortality. The precise","confidence":1,"confidence_rate":1},{"cnt":[[305,1238],[1779,1238],[1779,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1237,"width":1474,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed7a80755cb34b13866284e17bb633ad","type":"text","conversion_output":true,"text":"initiating injury is unknown, and the clinical course of IPF is variable. The fibrosis that","text_display":" initiating injury is unknown, and the clinical course of IPF is variable. The fibrosis that","confidence":1,"confidence_rate":1},{"cnt":[[305,1289],[1764,1289],[1764,1338],[305,1338]],"region":{"top_left_x":305,"top_left_y":1289,"width":1459,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea50c3be82b54ea2baaa37dae8fb073a","type":"text","conversion_output":true,"text":"develops in IPF follows a similar path to normal wound healing, but is progressive and","text_display":" develops in IPF follows a similar path to normal wound healing, but is progressive and","confidence":1,"confidence_rate":1},{"cnt":[[305,1343],[1695,1343],[1695,1390],[305,1390]],"region":{"top_left_x":305,"top_left_y":1342,"width":1391,"height":49},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed56e82aea52400b926ff6a587d2558f","type":"text","conversion_output":true,"text":"without resolution. A loss of control of the mechanisms halting the normal wound","text_display":" without resolution. A loss of control of the mechanisms halting the normal wound","confidence":1,"confidence_rate":1},{"cnt":[[305,1392],[1809,1392],[1809,1446],[305,1446]],"region":{"top_left_x":305,"top_left_y":1392,"width":1504,"height":54},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5dcea3a895404c9585fb05043b98f025","type":"text","conversion_output":true,"text":"healing process leads to persistence of inflammatory cells (particularly monocyte-derived","text_display":" healing process leads to persistence of inflammatory cells (particularly monocyte-derived","confidence":1,"confidence_rate":1},{"cnt":[[305,1446],[1697,1446],[1697,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1445,"width":1393,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"508eb0857cd94a89a75b4cea5b28ca7c","type":"text","conversion_output":true,"text":"cell populations such as macrophages and fibrocytes), elevated levels of cytokines,","text_display":" cell populations such as macrophages and fibrocytes), elevated levels of cytokines,","confidence":1,"confidence_rate":1},{"cnt":[[305,1497],[1704,1497],[1704,1549],[305,1549]],"region":{"top_left_x":305,"top_left_y":1497,"width":1399,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dca702928a754e45910e080e1eb98765","type":"text","conversion_output":true,"text":"chemokines, growth factors and other signaling molecules, excessive deposition of","text_display":" chemokines, growth factors and other signaling molecules, excessive deposition of","confidence":1,"confidence_rate":1},{"cnt":[[305,1551],[1697,1551],[1697,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1551,"width":1393,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"670e767bc6434bf8beb696c74895b630","type":"text","conversion_output":true,"text":"collagen types 1 and 3, and inhibition of enzymes that degrade extracellular matrix","text_display":" collagen types 1 and 3, and inhibition of enzymes that degrade extracellular matrix","confidence":0.95166015625,"confidence_rate":0.9994556725224907},{"cnt":[[305,1603],[1710,1603],[1710,1652],[305,1652]],"region":{"top_left_x":305,"top_left_y":1602,"width":1406,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"238185acabbf46a7beafe17fb403cf1a","type":"text","conversion_output":true,"text":"(ECM) proteins (Lupher and Gallatin 2006). Over time, continuing insults result in","text_display":" (ECM) proteins (Lupher and Gallatin 2006). Over time, continuing insults result in","confidence":1,"confidence_rate":1},{"cnt":[[305,1654],[1790,1654],[1790,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1654,"width":1485,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6574fcb2bc6c4be0ac1a53d485a9b4fb","type":"text","conversion_output":true,"text":"progressive lung fibrosis (pathologic accumulation of excessive ECM), and increasingly","text_display":" progressive lung fibrosis (pathologic accumulation of excessive ECM), and increasingly","confidence":1,"confidence_rate":1},{"cnt":[[305,1706],[1674,1706],[1674,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1705,"width":1369,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"133fd0b9b65140d19e406265807a0f17","type":"text","conversion_output":true,"text":"compromised lung function due to thickening/stiffening of the alveoli. Signs and","text_display":" compromised lung function due to thickening/stiffening of the alveoli. Signs and","confidence":1,"confidence_rate":1},{"cnt":[[305,1757],[1682,1757],[1682,1809],[305,1809]],"region":{"top_left_x":305,"top_left_y":1757,"width":1378,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66b4282d2dd240f7afc8183e95971bf3","type":"text","conversion_output":true,"text":"symptoms that develop over time include exertional dyspnea and cough as well as","text_display":" symptoms that develop over time include exertional dyspnea and cough as well as","confidence":1,"confidence_rate":1},{"cnt":[[305,1809],[1422,1809],[1422,1861],[305,1861]],"region":{"top_left_x":305,"top_left_y":1808,"width":1118,"height":53},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e42557b980d74b7fbd74fc10dc3b43f9","type":"text","conversion_output":true,"text":"fatigue, weight loss, myalgia, and clubbing of the fingers and toes.","text_display":" fatigue, weight loss, myalgia, and clubbing of the fingers and toes.","confidence":1,"confidence_rate":1},{"cnt":[[305,1884],[1747,1884],[1747,1934],[305,1934]],"region":{"top_left_x":305,"top_left_y":1884,"width":1442,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"baecc541d8044aa3853991f45611e2a5","type":"text","conversion_output":true,"text":"Ultimately, IPF leads to death, with a median survival after diagnosis of 3 years and a","text_display":"\n\nUltimately, IPF leads to death, with a median survival after diagnosis of 3 years and a","confidence":1,"confidence_rate":1},{"cnt":[[305,1934],[1777,1934],[1777,1985],[305,1985]],"region":{"top_left_x":305,"top_left_y":1933,"width":1472,"height":53},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"67a30ee444054747ad7106444bc92afd","type":"text","conversion_output":true,"text":"5 -year survival rate of \\(20 \\%\\) to \\(40 \\%\\) (Gomer and Lupher 2010). Estimates are that IPF is","text_display":" 5 -year survival rate of \\(20 \\%\\) to \\(40 \\%\\) (Gomer and Lupher 2010). Estimates are that IPF is","confidence":0.921875,"confidence_rate":0.9991530084890023},{"cnt":[[305,1987],[1807,1987],[1807,2039],[305,2039]],"region":{"top_left_x":305,"top_left_y":1987,"width":1502,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e27c91b67193407eb2d3758bb8d59a0d","type":"text","conversion_output":true,"text":"the primary cause of death for \\(60 \\%\\) of subjects with IPF, with death commonly occurring","text_display":" the primary cause of death for \\(60 \\%\\) of subjects with IPF, with death commonly occurring","confidence":0.9951171875,"confidence_rate":0.9999479293091645},{"cnt":[[305,2041],[1772,2041],[1772,2086],[305,2086]],"region":{"top_left_x":305,"top_left_y":2041,"width":1468,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"61a8c44c7e90473c9de15544845a1c6b","type":"text","conversion_output":true,"text":"after an acute exacerbation of the disease. When an acute exacerbation of IPF is not the","text_display":" after an acute exacerbation of the disease. When an acute exacerbation of IPF is not the","confidence":1,"confidence_rate":1},{"cnt":[[305,2093],[1811,2093],[1811,2142],[305,2142]],"region":{"top_left_x":305,"top_left_y":2092,"width":1507,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ee3cc420dd8945c48d458928eb3a8d31","type":"text","conversion_output":true,"text":"cause of death, other common causes include acute coronary syndromes, congestive heart","text_display":" cause of death, other common causes include acute coronary syndromes, congestive heart","confidence":1,"confidence_rate":1},{"cnt":[[305,2144],[1811,2144],[1811,2194],[305,2194]],"region":{"top_left_x":305,"top_left_y":2144,"width":1507,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0edcbf1c6f9a47ebadf37d77674079d4","type":"text","conversion_output":true,"text":"failure, lung cancer, infection, and venous thromboembolic disease (Frankel and Schwarz","text_display":" failure, lung cancer, infection, and venous thromboembolic disease (Frankel and Schwarz","confidence":1,"confidence_rate":1},{"cnt":[[305,2196],[423,2196],[423,2245],[305,2245]],"region":{"top_left_x":305,"top_left_y":2195,"width":119,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8474f59585114dc8b13d1bd4f208c218","type":"text","conversion_output":true,"text":"2009).","text_display":" 2009).","confidence":1,"confidence_rate":1},{"cnt":[[305,2245],[1762,2245],[1762,2295],[305,2295]],"region":{"top_left_x":305,"top_left_y":2245,"width":1457,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71291e0b500948d79d00354efae111aa","type":"text","conversion_output":true,"text":"No cure currently exists for IPF. There are two approved therapies in the United States","text_display":"\n\nNo cure currently exists for IPF. There are two approved therapies in the United States","confidence":1,"confidence_rate":1},{"cnt":[[305,2295],[1687,2295],[1687,2344],[305,2344]],"region":{"top_left_x":305,"top_left_y":2294,"width":1382,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87f1be818a004aacaef5a845ca4a9450","type":"text","conversion_output":true,"text":"and one in Europe. Pirfenidone was approved in the EU on February 28, 2011, for","text_display":" and one in Europe. Pirfenidone was approved in the EU on February 28, 2011, for","confidence":1,"confidence_rate":1},{"cnt":[[305,2342],[1815,2342],[1815,2391],[305,2391]],"region":{"top_left_x":305,"top_left_y":2341,"width":1511,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a81b2e2eafa24e1d8dfea9f53f414e31","type":"text","conversion_output":true,"text":"treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), based on a statistically","text_display":" treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), based on a statistically","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,2391],[1775,2391],[1775,2438],[305,2438]],"region":{"top_left_x":305,"top_left_y":2391,"width":1470,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"80e882b4862f47a8ba11c269d6ad2af6","type":"text","conversion_output":true,"text":"significant reduction in the decline of percent 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Although such therapies may ameliorate subjects'","confidence":1,"confidence_rate":1},{"cnt":[[305,1010],[1697,1010],[1697,1059],[305,1059]],"region":{"top_left_x":305,"top_left_y":1009,"width":1393,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8409848f219945c18683c9998fae6dce","type":"text","conversion_output":true,"text":"symptoms and improve comfort, they do not slow the progression of the disease or","text_display":" symptoms and improve comfort, they do not slow the progression of the disease or","confidence":0.99951171875,"confidence_rate":0.9999942541282946},{"cnt":[[305,1057],[1751,1057],[1751,1109],[305,1109]],"region":{"top_left_x":305,"top_left_y":1057,"width":1446,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3246e3394c45461eae18334e5accecb4","type":"text","conversion_output":true,"text":"prolong survival. 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PRM-151","text_display":"\n\n\\subsection*{1.2. PRM-151}","confidence":0.97412109375,"confidence_rate":0.9984588560288927},{"cnt":[[305,1444],[1779,1444],[1779,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1443,"width":1474,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d8469573a0f42c3b498e961a143d59d","type":"text","conversion_output":true,"text":"Pentraxin-2 (PTX-2), also called serum amyloid P (SAP), is an endogenous protein that","text_display":"\n\nPentraxin-2 (PTX-2), also called serum amyloid P (SAP), is an endogenous protein that","confidence":0.6964874267578125,"confidence_rate":0.9959891147513413},{"cnt":[[305,1495],[1772,1495],[1772,1549],[305,1549]],"region":{"top_left_x":305,"top_left_y":1495,"width":1468,"height":55},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8daa375ae52f4b59b959d76290b4423f","type":"text","conversion_output":true,"text":"circulates in the bloodstream. Recent discoveries about the biology of tissue repair and","text_display":" circulates in the bloodstream. Recent discoveries about the biology of tissue repair and","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[305,1547],[1749,1547],[1749,1601],[305,1601]],"region":{"top_left_x":305,"top_left_y":1546,"width":1444,"height":55},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43a55f1d9d2e4c3f87acfb27176c18a1","type":"text","conversion_output":true,"text":"fibrosis have elucidated the important role that PTX-2 plays biologically in regulating","text_display":" fibrosis have elucidated the important role that PTX-2 plays biologically in regulating","confidence":1,"confidence_rate":1},{"cnt":[[305,1601],[1785,1601],[1785,1652],[305,1652]],"region":{"top_left_x":305,"top_left_y":1600,"width":1481,"height":53},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35fa673b521c495d8692916675469885","type":"text","conversion_output":true,"text":"processes that relate to scar prevention and healing. PTX-2 is an agonist that binds to Fc","text_display":" processes that relate to scar prevention and healing. PTX-2 is an agonist that binds to Fc","confidence":1,"confidence_rate":1},{"cnt":[[305,1652],[1674,1652],[1674,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1652,"width":1369,"height":52},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"948471a1b0a8484c820b54c4f6bb7815","type":"text","conversion_output":true,"text":"gamma receptors on monocytes and promotes their differentiation into regulatory","text_display":" gamma receptors on monocytes and promotes their differentiation into regulatory","confidence":1,"confidence_rate":1},{"cnt":[[305,1704],[1725,1704],[1725,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1703,"width":1421,"height":53},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3bf87502a2b04a898554148d2bc206eb","type":"text","conversion_output":true,"text":"macrophages (Mreg), which function to promote epithelial healing and resolution of","text_display":" macrophages (Mreg), which function to promote epithelial healing and resolution of","confidence":1,"confidence_rate":1},{"cnt":[[305,1755],[1751,1755],[1751,1807],[305,1807]],"region":{"top_left_x":305,"top_left_y":1755,"width":1446,"height":52},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25e80edf8b154c4c8876c622a7e47d67","type":"text","conversion_output":true,"text":"inflammation and scarring. 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Both","confidence":1,"confidence_rate":1},{"cnt":[[305,1861],[1749,1861],[1749,1910],[305,1910]],"region":{"top_left_x":305,"top_left_y":1860,"width":1444,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e84d8cbd891949d5bd80a14acb50493e","type":"text","conversion_output":true,"text":"increased fibrocyte numbers in circulation (Moeller, Gilpin et al. 2009) and decreased","text_display":" increased fibrocyte numbers in circulation (Moeller, Gilpin et al. 2009) and decreased","confidence":1,"confidence_rate":1},{"cnt":[[305,1912],[1751,1912],[1751,1962],[305,1962]],"region":{"top_left_x":305,"top_left_y":1912,"width":1446,"height":50},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0031a93ad0c4be2b8148299c2c16f08","type":"text","conversion_output":true,"text":"levels of circulating PTX-2 (Murray, Chen et al. 2011) have been characterized in IPF","text_display":" levels of circulating PTX-2 (Murray, Chen et al. 2011) have been characterized in IPF","confidence":1,"confidence_rate":1},{"cnt":[[305,1964],[913,1964],[913,2017],[305,2017]],"region":{"top_left_x":305,"top_left_y":1963,"width":609,"height":55},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dca44da3bdff4980a6b2bd4b5a6a42b2","type":"text","conversion_output":true,"text":"subjects relative to healthy subjects.","text_display":" subjects relative to healthy subjects.","confidence":1,"confidence_rate":1},{"cnt":[[305,2037],[1813,2037],[1813,2088],[305,2088]],"region":{"top_left_x":305,"top_left_y":2036,"width":1509,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"555b4d5b7d12489eaacb11af1a036bc9","type":"text","conversion_output":true,"text":"PRM-151 is a recombinantly-expressed version of human pentraxin-2 (hPTX-2). Like the","text_display":"\n\nPRM-151 is a recombinantly-expressed version of human pentraxin-2 (hPTX-2). Like the","confidence":1,"confidence_rate":1},{"cnt":[[305,2088],[1714,2088],[1714,2142],[305,2142]],"region":{"top_left_x":305,"top_left_y":2088,"width":1410,"height":54},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e48e33dc1434666a7d9f2b73f2dd1e3","type":"text","conversion_output":true,"text":"native human protein, PRM-151 is expressed and purified as a non-covalent, homo-","text_display":" native human protein, PRM-151 is expressed and purified as a non-covalent, homo","confidence":1,"confidence_rate":1},{"cnt":[[305,2140],[1721,2140],[1721,2194],[305,2194]],"region":{"top_left_x":305,"top_left_y":2139,"width":1416,"height":55},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f7d5ee3f752489fa0e9838a0c82ae73","type":"text","conversion_output":true,"text":"pentameric glycoprotein. Each monomer in the pentamer is comprised of 204 amino","text_display":"pentameric glycoprotein. 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There is one intramolecular disulfide bond between the only 2","text_display":" biantennary structure. There is one intramolecular disulfide bond between the only 2","confidence":1,"confidence_rate":1},{"cnt":[[305,2297],[1781,2297],[1781,2348],[305,2348]],"region":{"top_left_x":305,"top_left_y":2296,"width":1477,"height":53},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef63bc6f369747059a17382d90ebeb36","type":"text","conversion_output":true,"text":"cysteine residues in each monomer: Cys36-Cys95. The average molecular weight of the","text_display":" cysteine residues in each monomer: Cys36-Cys95. The average molecular weight of the","confidence":1,"confidence_rate":1},{"cnt":[[305,2350],[1205,2350],[1205,2402],[305,2402]],"region":{"top_left_x":305,"top_left_y":2350,"width":901,"height":52},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ebc24f38a36f4168a31e19f65afa3df4","type":"text","conversion_output":true,"text":"fully glycosylated, sialylated pentamer is 127313 Da.","text_display":" fully glycosylated, sialylated pentamer is 127313 Da.","confidence":0.9833984375,"confidence_rate":0.9997255964607712},{"cnt":[[1038,2557],[1089,2557],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2556,"width":53,"height":38},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c930309b64644bf78abee3ac195f5eac","type":"page_info","conversion_output":false,"text":"20","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"05532668-04bd-4780-8ef0-43abd30e1f06-21","page":21,"lines":[{"cnt":[[309,138],[449,138],[449,170],[309,170]],"region":{"top_left_x":309,"top_left_y":137,"width":141,"height":33},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"673cb187b9184dcfbd38ed81288f5d16","type":"page_info","conversion_output":false,"text":"PRM-151","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,189],[728,189],[728,230],[309,230]],"region":{"top_left_x":309,"top_left_y":189,"width":420,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b0f629bae58249539f98c9fbaba47c26","type":"page_info","conversion_output":false,"text":"Study Protocol PRM-151-202","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1652,189],[1818,189],[1818,226],[1652,226]],"region":{"top_left_x":1652,"top_left_y":189,"width":166,"height":37},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b9bbfe786fde499286fb69394e0b3a15","type":"page_info","conversion_output":false,"text":"Version 4.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,292],[1656,292],[1656,337],[305,337]],"region":{"top_left_x":305,"top_left_y":292,"width":1352,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ed005b548ba743f3b68dbca9a9aa2827","type":"text","conversion_output":true,"text":"Preclinical and clinical data exist to support the investigation of PRM-151 in the","text_display":"\n\nPreclinical and clinical data exist to support the investigation of PRM-151 in the","confidence":0.99951171875,"confidence_rate":0.9999943862169285},{"cnt":[[309,344],[806,344],[806,385],[309,385]],"region":{"top_left_x":309,"top_left_y":343,"width":497,"height":42},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"511718ee8d114fcea92ab05ac36718e0","type":"text","conversion_output":true,"text":"treatment of fibrotic diseases.","text_display":" treatment of fibrotic diseases.","confidence":1,"confidence_rate":1},{"cnt":[[309,412],[975,412],[975,466],[309,466]],"region":{"top_left_x":309,"top_left_y":412,"width":667,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dd4af7a5a9e40a0862c8379f7be822f","type":"section_header","conversion_output":false,"children_ids":["98c06b7ae7f84afa81a8e1cfc87369c6"],"text":"","text_display":""},{"cnt":[[314,417],[969,417],[969,466],[314,466]],"region":{"top_left_x":313,"top_left_y":416,"width":656,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98c06b7ae7f84afa81a8e1cfc87369c6","type":"text","conversion_output":true,"parent_id":"4dd4af7a5a9e40a0862c8379f7be822f","text":"1.2.1. Preclinical Pharmacology","text_display":"\n\n\\subsection*{1.2.1. Preclinical Pharmacology}","confidence":0.9970703125,"confidence_rate":0.99991850367004},{"cnt":[[309,490],[1798,490],[1798,535],[309,535]],"region":{"top_left_x":309,"top_left_y":489,"width":1490,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0d3f08b66ff44ad8b2f3fa541a21971","type":"text","conversion_output":true,"text":"Following the initial in vitro discovery by Gomer and Pilling suggesting that PTX-2 may","text_display":"\n\nFollowing the initial in vitro discovery by Gomer and Pilling suggesting that PTX-2 may","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[309,541],[1768,541],[1768,587],[309,587]],"region":{"top_left_x":309,"top_left_y":541,"width":1460,"height":46},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6dd7dfa76fa459a95f02a4760445ade","type":"text","conversion_output":true,"text":"regulate monocyte differentiation into spindle shaped fibrocytes (Pilling, Buckley et al.","text_display":" regulate monocyte differentiation into spindle shaped fibrocytes (Pilling, Buckley et al.","confidence":1,"confidence_rate":1},{"cnt":[[309,593],[1717,593],[1717,638],[309,638]],"region":{"top_left_x":309,"top_left_y":592,"width":1408,"height":47},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bfeefe5caac43c9bf2a3aa12df422e4","type":"text","conversion_output":true,"text":"2003), they, with others, published several studies on the activity of species-specific","text_display":" 2003), they, with others, published several studies on the activity of species-specific","confidence":0.9990234375,"confidence_rate":0.9999893800602199},{"cnt":[[309,645],[1682,645],[1682,692],[309,692]],"region":{"top_left_x":309,"top_left_y":644,"width":1374,"height":48},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"363d0123c5b24489887ac5e3756c916e","type":"text","conversion_output":true,"text":"serum-derived PTX-2 in preventing fibrosis in models of bleomycin-induced lung","text_display":" serum-derived PTX-2 in preventing fibrosis in models of bleomycin-induced lung","confidence":1,"confidence_rate":1},{"cnt":[[309,696],[1725,696],[1725,746],[309,746]],"region":{"top_left_x":309,"top_left_y":696,"width":1417,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70d6cb50ba7c4cfb85f4b9582bf663fe","type":"text","conversion_output":true,"text":"fibrosis in rats and mice and also in a model of ischemia reperfusion injury to mouse","text_display":" fibrosis in rats and mice and also in a model of ischemia reperfusion injury to mouse","confidence":1,"confidence_rate":1},{"cnt":[[309,750],[1596,750],[1596,797],[309,797]],"region":{"top_left_x":309,"top_left_y":749,"width":1288,"height":49},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6038916cc58a42b8acfe21848da21210","type":"text","conversion_output":true,"text":"heart (Pilling, Roife et al. 2007),(Haudek, Xia et al. 2006). Promedior and its","text_display":" heart (Pilling, Roife et al. 2007),(Haudek, Xia et al. 2006). 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Review of other pulmonary function tests (PTFs) showed an","text_display":" in FVC \\% predicted. Review of other pulmonary function tests (PTFs) showed an","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[309,812],[1721,812],[1721,862],[309,862]],"region":{"top_left_x":309,"top_left_y":812,"width":1412,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ebc18f60de24ee09b5d2edf3381aef9","type":"text","conversion_output":true,"text":"increase from Baseline in forced expiratory volume in 1 second \\(\\left( FEV _{1}\\right)\\) in all 3 dose","text_display":" increase from Baseline in forced expiratory volume in 1 second \\(\\left( FEV _{1}\\right)\\) in all 3 dose","confidence":0.97412109375,"confidence_rate":0.9997549864988852},{"cnt":[[309,864],[1738,864],[1738,913],[309,913]],"region":{"top_left_x":309,"top_left_y":863,"width":1430,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a5577a5295284c05a20d6bfd0480744e","type":"text","conversion_output":true,"text":"groups, whereas a decrease from Baseline was seen in the placebo group; none of the","text_display":" groups, whereas a decrease from Baseline was seen in the placebo group; none of the","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[309,915],[1712,915],[1712,965],[309,965]],"region":{"top_left_x":309,"top_left_y":915,"width":1404,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e1f2d24fbdfc49238ef8860e4e48f7d5","type":"text","conversion_output":true,"text":"between group differences was statistically significant. Mean PFTs at Baseline and","text_display":" between group differences was statistically significant. Mean PFTs at Baseline and","confidence":1,"confidence_rate":1},{"cnt":[[309,967],[1360,967],[1360,1016],[309,1016]],"region":{"top_left_x":309,"top_left_y":966,"width":1051,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4213208cf7094d0ab0aef50ad8961a6f","type":"text","conversion_output":true,"text":"change from Baseline on Day 57 are summarized in Table 1-1.","text_display":" change from Baseline on Day 57 are summarized in Table 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\\multirow[b]{2}{*}{Parameter} & \\multirow[b]{2}{*}{Placebo ( \\(N =6\\) )} & \\multicolumn{4}{|c|}{PRM-151} \\\\\n\\hline & & \\(1 ~ m g / k g\\) ( \\(N =5\\) ) & \\(5 ~ m g / k g\\) ( \\(N =5\\) ) & \\(1 0 ~ m g / k g\\) ( \\(N =4\\) ) & All Doses ( \\(N =14\\) ) \\\\\n\\hline \\multicolumn{6}{|l|}{FVC (liters)} \\\\\n\\hline Baseline & 2.2 (0.64) & 3.0 (0.85) & 2.8 (0.73) & 3.0 (0.71) & 2.9 (0.71) \\\\\n\\hline \\(\\Delta\\) from & -0.06 (0.116) & 0.06 (0.164) & 0.06 (0.074) & 0.08 (0.210) & 0.06 (0.142) \\\\\n\\hline \\multicolumn{6}{|l|}{FVC \\% predicted (\\%)} \\\\\n\\hline Baseline & 63 (16.7) & 82 (15.5) & 80 (7.8) & 73 (14.3) & 79 (12.5) \\\\\n\\hline \\(\\Delta\\) from & -1.5 (3.3) & 2.4 (4.6) & 2.8 (3.0) & 1.8 (5.3) & 2.4 (4.0) \\\\\n\\hline \\multicolumn{6}{|l|}{DLco (\\%)} \\\\\n\\hline Baseline & 35 (8.4) & 41 (10.5) & 53 (9.8) & 46 (7.2) & 47 (10.1) \\\\\n\\hline \\(\\Delta\\) from Baseline & -2.3 (2.1) & 0.2 (3.3) & -4.0 (6.8) & -1.5 (3.8) & -1.8 (4.9) \\\\\n\\hline 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group","confidence":0.9941522984322546,"confidence_rate":0.9999348369418319},{"cnt":[[309,2363],[1790,2363],[1790,2411],[309,2411]],"region":{"top_left_x":309,"top_left_y":2363,"width":1481,"height":48},"line":136,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51a4fb252cbe4a7ab430eec8873511e8","type":"text","conversion_output":true,"text":"compared with a numerical improvement in each of the \\(5 mg / kg , 10 mg / kg\\), and all dose","text_display":" compared with a numerical improvement in each of the \\(5 mg / kg , 10 mg / kg\\), and all dose","confidence":1,"confidence_rate":1},{"cnt":[[309,2415],[1721,2415],[1721,2464],[309,2464]],"region":{"top_left_x":309,"top_left_y":2414,"width":1412,"height":51},"line":137,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41381b3fec7e4a719130b8a1c0ff9d59","type":"text","conversion_output":true,"text":"combined groups \\([+6( SD , 43),+35( SD , 45)\\), and \\(+8( SD , 51)\\) meters, 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Protocol PRM-151-202","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1650,189],[1820,189],[1820,226],[1650,226]],"region":{"top_left_x":1650,"top_left_y":189,"width":170,"height":37},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be8340a3ee0d4f038e90a1ca97140fb6","type":"page_info","conversion_output":false,"text":"Version 4.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,288],[1760,288],[1760,339],[305,339]],"region":{"top_left_x":305,"top_left_y":287,"width":1455,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ef7c4c4f6714593bf9af7b3ccc1748c","type":"text","conversion_output":true,"text":"although these differences were not statistically significant. No infusion reactions, no","text_display":"\nalthough these differences were not statistically significant. No infusion reactions, no","confidence":0.99951171875,"confidence_rate":0.9999947483955305},{"cnt":[[305,339],[1699,339],[1699,393],[305,393]],"region":{"top_left_x":305,"top_left_y":339,"width":1395,"height":55},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bdab2094194741058dd3dae1e7a11209","type":"text","conversion_output":true,"text":"dose-limiting toxicity and no serious adverse events were observed. In addition, no","text_display":" dose-limiting toxicity and no serious adverse events were observed. In addition, no","confidence":1,"confidence_rate":1},{"cnt":[[305,391],[1695,391],[1695,443],[305,443]],"region":{"top_left_x":305,"top_left_y":391,"width":1391,"height":52},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2520326bff54a1ca978b56971ea199d","type":"text","conversion_output":true,"text":"antibodies to PRM-151 were measured. In the PRM-151-treated subjects, the most","text_display":" antibodies to PRM-151 were measured. In the PRM-151-treated subjects, the most","confidence":1,"confidence_rate":1},{"cnt":[[305,443],[1779,443],[1779,496],[305,496]],"region":{"top_left_x":305,"top_left_y":442,"width":1474,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88db9863d1c743b0bb7ba44118a3fcfb","type":"text","conversion_output":true,"text":"common adverse events recorded during the study were cough ( \\(n =7 ; 47 \\%\\) ), productive","text_display":" common adverse events recorded during the study were cough ( \\(n =7 ; 47 \\%\\) ), productive","confidence":0.9946377224997605,"confidence_rate":0.9999421876269684},{"cnt":[[305,494],[1723,494],[1723,548],[305,548]],"region":{"top_left_x":305,"top_left_y":494,"width":1419,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28ceb259dd8c438c9ec9a3fe79b4ff20","type":"text","conversion_output":true,"text":"cough ( \\(n =4 ; 27 \\%\\) ) followed by fatigue ( \\(n =3 ; 20 \\%\\) ) and headache ( \\(n =3 ; 20 \\%\\) ). The","text_display":" cough ( \\(n =4 ; 27 \\%\\) ) followed by fatigue ( \\(n =3 ; 20 \\%\\) ) and headache ( \\(n =3 ; 20 \\%\\) ). The","confidence":0.9926898427074775,"confidence_rate":0.9999280711416629},{"cnt":[[305,546],[1723,546],[1723,599],[305,599]],"region":{"top_left_x":305,"top_left_y":545,"width":1419,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4f4adee48ce349098a8c4934d2d9f14d","type":"text","conversion_output":true,"text":"incidence of these events was comparable in the placebo group [cough, \\(33 \\%( n =2)\\);","text_display":" incidence of these events was comparable in the placebo group [cough, \\(33 \\%( n =2)\\);","confidence":0.9970724578015506,"confidence_rate":0.9999677825428174},{"cnt":[[305,597],[1807,597],[1807,651],[305,651]],"region":{"top_left_x":305,"top_left_y":597,"width":1502,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9630879ec53b48c7835f3861c99e595e","type":"text","conversion_output":true,"text":"productive cough, \\(33 \\%( n =2)\\); fatigue, \\(17 \\%( n =1)\\) and headache, \\(17 \\%( n =1)]\\). Neither","text_display":" productive cough, \\(33 \\%( n =2)\\); fatigue, \\(17 \\%( n =1)\\) and headache, \\(17 \\%( n =1)]\\). Neither","confidence":0.7403986270073801,"confidence_rate":0.9970861317084766},{"cnt":[[305,653],[1760,653],[1760,707],[305,707]],"region":{"top_left_x":305,"top_left_y":653,"width":1455,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f8dba03f6d2428b82d07486cb947641","type":"text","conversion_output":true,"text":"the nature nor the frequency of these reported adverse events increased with ascending","text_display":" the nature nor the frequency of these reported adverse events increased with ascending","confidence":1,"confidence_rate":1},{"cnt":[[305,705],[1790,705],[1790,758],[305,758]],"region":{"top_left_x":305,"top_left_y":704,"width":1485,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3336fa6d9acf42e3b610089928a3ef1e","type":"text","conversion_output":true,"text":"PRM-151 dose levels. One subject in the \\(1 mg / kg\\) dose group experienced an episode of","text_display":" PRM-151 dose levels. One subject in the \\(1 mg / kg\\) dose group experienced an episode of","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[305,756],[1796,756],[1796,810],[305,810]],"region":{"top_left_x":305,"top_left_y":756,"width":1492,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0cb2d15c97840bfa6014c2fe7c31ca3","type":"text","conversion_output":true,"text":"moderate hypotension and dizziness just before administration of the third dose of PRM-","text_display":" moderate hypotension and dizziness just before administration of the third dose of PRM","confidence":1,"confidence_rate":1},{"cnt":[[309,808],[1790,808],[1790,862],[309,862]],"region":{"top_left_x":309,"top_left_y":807,"width":1481,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70917b5d1c254b84bed9c91588be8c36","type":"text","conversion_output":true,"text":"151. These symptoms were considered possibly related to PRM-151 administration, and","text_display":"151. These symptoms were considered possibly related to PRM-151 administration, and","confidence":0.9990234375,"confidence_rate":0.9999888973383643},{"cnt":[[305,862],[1555,862],[1555,913],[305,913]],"region":{"top_left_x":305,"top_left_y":861,"width":1251,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51f9c5d318c24b76ae871e0157b65bd8","type":"text","conversion_output":true,"text":"resulted in discontinuation of PRM-151 treatment for that specific subject.","text_display":" resulted in discontinuation of PRM-151 treatment for that specific subject.","confidence":1,"confidence_rate":1},{"cnt":[[305,935],[1798,935],[1798,986],[305,986]],"region":{"top_left_x":305,"top_left_y":934,"width":1494,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"14890a07feba4dd787537e9368171c5f","type":"text","conversion_output":true,"text":"In a Phase 2 study in subjects with myelofibrosis treated with PRM-151 either weekly or","text_display":"\n\nIn a Phase 2 study in subjects with myelofibrosis treated with PRM-151 either weekly or","confidence":1,"confidence_rate":1},{"cnt":[[305,986],[1815,986],[1815,1038],[305,1038]],"region":{"top_left_x":305,"top_left_y":986,"width":1511,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ad480e9dc2394513b379fd8f6fa4fcd5","type":"text","conversion_output":true,"text":"every 4 weeks, either alone or added to a stable dose of ruxolitinib, data on all 20 subjects","text_display":" every 4 weeks, either alone or added to a stable dose of ruxolitinib, data on all 20 subjects","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1775,1040],[1775,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1470,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d20db4178d44ebebb9f0fe3daae54eb","type":"text","conversion_output":true,"text":"who completed 24 weeks of treatment and 10 who have completed at least 36 weeks of","text_display":" who completed 24 weeks of treatment and 10 who have completed at least 36 weeks of","confidence":0.99755859375,"confidence_rate":0.9999745379143542},{"cnt":[[305,1091],[1792,1091],[1792,1141],[305,1141]],"region":{"top_left_x":305,"top_left_y":1091,"width":1487,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03e398bc32314c5d9d3f1730bf427770","type":"text","conversion_output":true,"text":"treatment as of Sept. 29, 2014 have demonstrated reduction in bone marrow fibrosis in 9","text_display":" treatment as of Sept. 29, 2014 have demonstrated reduction in bone marrow fibrosis in 9","confidence":0.99609375,"confidence_rate":0.9999583636399967},{"cnt":[[305,1143],[1781,1143],[1781,1195],[305,1195]],"region":{"top_left_x":305,"top_left_y":1142,"width":1477,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51bbdcc1db514784ba0e9c64a036165d","type":"text","conversion_output":true,"text":"subjects and improvement in anemia and/or thrombocytopenia in 9 subjects, 5 of whom","text_display":" subjects and improvement in anemia and/or thrombocytopenia in 9 subjects, 5 of whom","confidence":1,"confidence_rate":1},{"cnt":[[305,1195],[1721,1195],[1721,1246],[305,1246]],"region":{"top_left_x":305,"top_left_y":1194,"width":1416,"height":53},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d098989f9664fe4a81ea80a8a155e8f","type":"text","conversion_output":true,"text":"also had bone marrow improvement. Treatment emergent adverse events have been","text_display":" also had bone marrow improvement. Treatment emergent adverse events have been","confidence":1,"confidence_rate":1},{"cnt":[[305,1246],[1734,1246],[1734,1298],[305,1298]],"region":{"top_left_x":305,"top_left_y":1246,"width":1429,"height":52},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1de972c5c09c4ba3be47300286882788","type":"text","conversion_output":true,"text":"mostly mild (Grade 1 or 2 by the CTCAE criteria) and unrelated to PRM-151. There","text_display":" mostly mild (Grade 1 or 2 by the CTCAE criteria) and unrelated to PRM-151. There","confidence":1,"confidence_rate":1},{"cnt":[[305,1300],[1729,1300],[1729,1351],[305,1351]],"region":{"top_left_x":305,"top_left_y":1299,"width":1425,"height":53},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"892809cbf268459681c2d5a710bd4dd3","type":"text","conversion_output":true,"text":"were 2 instances of infusion reactions (Grade 2); in each case, subsequent treatments","text_display":" were 2 instances of infusion reactions (Grade 2); in each case, subsequent treatments","confidence":0.9951240993104875,"confidence_rate":0.9999474441050268},{"cnt":[[305,1354],[1669,1354],[1669,1403],[305,1403]],"region":{"top_left_x":305,"top_left_y":1353,"width":1365,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efc548ca586240b3a08ff7aed6331e04","type":"text","conversion_output":true,"text":"were uneventful with diphenhydramine and dexamethasone administered prior to","text_display":" were uneventful with diphenhydramine and dexamethasone administered prior to","confidence":1,"confidence_rate":1},{"cnt":[[305,1405],[1714,1405],[1714,1454],[305,1454]],"region":{"top_left_x":305,"top_left_y":1405,"width":1410,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8e4a993377d4b7c8fb8aeaa8829bafc","type":"text","conversion_output":true,"text":"treatment. There were 5 serious adverse events (SAEs) considered possibly related,","text_display":" treatment. There were 5 serious adverse events (SAEs) considered possibly related,","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[305,1457],[1781,1457],[1781,1506],[305,1506]],"region":{"top_left_x":305,"top_left_y":1456,"width":1477,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"781975d86c904f8aba9abbeebeaff877","type":"text","conversion_output":true,"text":"including 1 death. These included abdominal pain (recovered), sialadenitis (recovered),","text_display":" including 1 death. These included abdominal pain (recovered), sialadenitis (recovered),","confidence":1,"confidence_rate":1},{"cnt":[[305,1508],[1721,1508],[1721,1558],[305,1558]],"region":{"top_left_x":305,"top_left_y":1508,"width":1416,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c36c5bd4b334e16ae2de2787f5607a8","type":"text","conversion_output":true,"text":"respiratory syncytial virus (recovered), and gastroenteritis (norovirus documented in","text_display":" respiratory syncytial virus (recovered), and gastroenteritis (norovirus documented in","confidence":1,"confidence_rate":1},{"cnt":[[305,1560],[1687,1560],[1687,1611],[305,1611]],"region":{"top_left_x":305,"top_left_y":1559,"width":1382,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87f7d1593fdf4c569691845e95450139","type":"text","conversion_output":true,"text":"entire family) and pneumonia (death). There were two unrelated deaths including","text_display":" entire family) and pneumonia (death). There were two unrelated deaths including","confidence":1,"confidence_rate":1},{"cnt":[[305,1611],[1749,1611],[1749,1663],[305,1663]],"region":{"top_left_x":305,"top_left_y":1611,"width":1444,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30c028c4395241d58f644cc51b3a4d7a","type":"text","conversion_output":true,"text":"pneumonia (subject voluntarily discontinued all medications including antibiotics and","text_display":" pneumonia (subject voluntarily discontinued all medications including antibiotics and","confidence":1,"confidence_rate":1},{"cnt":[[305,1663],[1729,1663],[1729,1717],[305,1717]],"region":{"top_left_x":305,"top_left_y":1662,"width":1425,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fec5b9ed772c43bca51793974415a666","type":"text","conversion_output":true,"text":"subsequently died) and multi-organ failure and cardiac arrest (automatic implantable","text_display":" subsequently died) and multi-organ failure and cardiac arrest (automatic implantable","confidence":1,"confidence_rate":1},{"cnt":[[305,1714],[1742,1714],[1742,1768],[305,1768]],"region":{"top_left_x":305,"top_left_y":1714,"width":1438,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e033fb84b114d39b8bd2a1c19ff5b08","type":"text","conversion_output":true,"text":"cardioverter defibrillator failed) after bone marrow biopsy site hematoma in a subject","text_display":" cardioverter defibrillator failed) after bone marrow biopsy site hematoma in a subject","confidence":1,"confidence_rate":1},{"cnt":[[305,1766],[1646,1766],[1646,1820],[305,1820]],"region":{"top_left_x":305,"top_left_y":1766,"width":1341,"height":54},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"30abd593b89e4e05b8fb624cc74f27df","type":"text","conversion_output":true,"text":"with a pre-existing arrhythmia. 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Areas of moderate or severe LAA that are characteristic of","text_display":" parenchyma or mild LAA). Areas of moderate or severe LAA that are characteristic of","confidence":1,"confidence_rate":1},{"cnt":[[305,2007],[1807,2007],[1807,2056],[305,2056]],"region":{"top_left_x":305,"top_left_y":2006,"width":1502,"height":51},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e17b77b655bc4175ac833abc1a5cce49","type":"text","conversion_output":true,"text":"emphysema were excluded from the analysis. Quantitative imaging data was analyzed in","text_display":" emphysema were excluded from the analysis. Quantitative imaging data was analyzed in","confidence":1,"confidence_rate":1},{"cnt":[[309,2058],[1714,2058],[1714,2108],[309,2108]],"region":{"top_left_x":309,"top_left_y":2058,"width":1406,"height":50},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f34e348e815f409495cf5fb192ea97a3","type":"text","conversion_output":true,"text":"16 subjects who had \\(\\leq 36\\) days between screening CT and Day 1 PFTs. There was a","text_display":" 16 subjects who had \\(\\leq 36\\) days between screening CT and Day 1 PFTs. 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The","text_display":" possibly due the limitations inherent to retrospective analysis of the HRCT data. 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been","confidence":1,"confidence_rate":1},{"cnt":[[305,344],[872,344],[872,391],[305,391]],"region":{"top_left_x":305,"top_left_y":343,"width":568,"height":49},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5d93ca5c61514865b39974a81b5a42cf","type":"text","conversion_output":true,"text":"performed at TLC on the Day 57.","text_display":" performed at TLC on the Day 57.","confidence":1,"confidence_rate":1},{"cnt":[[305,406],[1111,406],[1111,471],[305,471]],"region":{"top_left_x":305,"top_left_y":406,"width":806,"height":65},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"43195cedcd104a8ebe75a45334d92154","type":"section_header","conversion_output":false,"children_ids":["7990197bb151429b80a6611e99f90355"],"text":"","text_display":""},{"cnt":[[309,412],[1104,412],[1104,466],[309,466]],"region":{"top_left_x":309,"top_left_y":412,"width":796,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7990197bb151429b80a6611e99f90355","type":"text","conversion_output":true,"parent_id":"43195cedcd104a8ebe75a45334d92154","text":"1.4 Rationale for Current Study","text_display":"\n\n\\subsection*{1.4 Rationale for Current Study}","confidence":0.5615234375,"confidence_rate":0.9840972017149997},{"cnt":[[305,490],[1708,490],[1708,539],[305,539]],"region":{"top_left_x":305,"top_left_y":489,"width":1404,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f81aa74f37d428bae4e48b847400cf2","type":"text","conversion_output":true,"text":"IPF is a progressive disease that leads to significant morbidity and mortality, with a","text_display":"\n\nIPF is a progressive disease that leads to significant morbidity and mortality, with a","confidence":1,"confidence_rate":1},{"cnt":[[305,541],[1815,541],[1815,591],[305,591]],"region":{"top_left_x":305,"top_left_y":541,"width":1511,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97cf4fb18bdc45e596e3b21f05bfbc2e","type":"text","conversion_output":true,"text":"median survival after diagnosis of 3 years and a 5 -year survival rate of 20 to \\(40 \\%\\) (Gomer","text_display":" median survival after diagnosis of 3 years and a 5 -year survival rate of 20 to \\(40 \\%\\) (Gomer","confidence":0.951351903462637,"confidence_rate":0.9995340221556563},{"cnt":[[307,593],[1755,593],[1755,642],[307,642]],"region":{"top_left_x":307,"top_left_y":592,"width":1449,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"962c319456e04085ba5af5e1ff5c3272","type":"text","conversion_output":true,"text":"and Lupher 2010). Despite the two recently approved therapies, no therapies have yet","text_display":" and Lupher 2010). Despite the two recently approved therapies, no therapies have yet","confidence":1,"confidence_rate":1},{"cnt":[[305,645],[1798,645],[1798,694],[305,694]],"region":{"top_left_x":305,"top_left_y":644,"width":1494,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8add152afc9a42a38733dcd03931fa35","type":"text","conversion_output":true,"text":"been developed for IPF that meaningfully reverse the progressive lung fibrosis that is the","text_display":" been developed for IPF that meaningfully reverse the progressive lung fibrosis that is the","confidence":1,"confidence_rate":1},{"cnt":[[305,696],[1783,696],[1783,746],[305,746]],"region":{"top_left_x":305,"top_left_y":696,"width":1479,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"271a0f23901f494fb9d19c4eabe79960","type":"text","conversion_output":true,"text":"basic pathologic feature of the disease and no therapies have reproducibly demonstrated","text_display":" basic pathologic feature of the disease and no therapies have reproducibly demonstrated","confidence":1,"confidence_rate":1},{"cnt":[[305,748],[1768,748],[1768,797],[305,797]],"region":{"top_left_x":305,"top_left_y":747,"width":1464,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aef98d48ec3447edb746b7b7d337aa3e","type":"text","conversion_output":true,"text":"an improvement in lung function. IPF remains a progressive disease with no cure other","text_display":" an improvement in lung function. IPF remains a progressive disease with no cure other","confidence":1,"confidence_rate":1},{"cnt":[[305,799],[1772,799],[1772,849],[305,849]],"region":{"top_left_x":305,"top_left_y":799,"width":1468,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2ba1e423d674ff19264508226291895","type":"text","conversion_output":true,"text":"than lung transplant in selected subjects. Thus, there is still a significant unmet medical","text_display":" than lung transplant in selected subjects. Thus, there is still a significant unmet medical","confidence":1,"confidence_rate":1},{"cnt":[[305,853],[1796,853],[1796,904],[305,904]],"region":{"top_left_x":305,"top_left_y":852,"width":1492,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3b19ab8815604862bc8144fd8b491696","type":"text","conversion_output":true,"text":"need for subjects with IPF, particularly those with severe disease (Nalysnyk, Cid-Ruzafa","text_display":" need for subjects with IPF, particularly those with severe disease (Nalysnyk, Cid-Ruzafa","confidence":1,"confidence_rate":1},{"cnt":[[305,907],[513,907],[513,952],[305,952]],"region":{"top_left_x":305,"top_left_y":906,"width":209,"height":46},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8ad0b8731fb5490d9d5c70b2dd0d5b39","type":"text","conversion_output":true,"text":"et al. 2012).","text_display":" et al. 2012).","confidence":1,"confidence_rate":1},{"cnt":[[305,980],[1820,980],[1820,1029],[305,1029]],"region":{"top_left_x":305,"top_left_y":979,"width":1515,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b396351be18843e6a8bc6802e81e54e1","type":"text","conversion_output":true,"text":"As summarized previously, encouraging efficacy data were obtained in a Phase 1 study of","text_display":"\n\nAs summarized previously, encouraging efficacy data were obtained in a Phase 1 study of","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,1079],[305,1025],[1663,1027],[1663,1081]],"region":{"top_left_x":305,"top_left_y":1024,"width":1358,"height":57},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba10332bfe6a4be6ba49d48245012953","type":"text","conversion_output":true,"text":"PRM-151 in a relatively small number of subjects with IPF \\(( n =15)\\) who received","text_display":" PRM-151 in a relatively small number of subjects with IPF \\(( n =15)\\) who received","confidence":0.6884749685414135,"confidence_rate":0.9957672072858404},{"cnt":[[305,1083],[1714,1083],[1714,1132],[305,1132]],"region":{"top_left_x":305,"top_left_y":1082,"width":1410,"height":51},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f0c869b6134490cbdd43f0e1c70ebbb","type":"text","conversion_output":true,"text":"PRM-151 administered via 30 -minute IV infusion at doses of 1,5 , and \\(10 mg / kg\\) on","text_display":" PRM-151 administered via 30 -minute IV infusion at doses of 1,5 , and \\(10 mg / kg\\) on","confidence":0.9305505752563477,"confidence_rate":0.9992804704695845},{"cnt":[[305,1134],[1656,1134],[1656,1184],[305,1184]],"region":{"top_left_x":305,"top_left_y":1134,"width":1352,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c40e9e62c8f456a82975b44cf4f794e","type":"text","conversion_output":true,"text":"Days 1, 3, 5, 8, and 15, with all 3 groups demonstrating improvement in FVC \\%","text_display":" Days 1, 3, 5, 8, and 15, with all 3 groups demonstrating improvement in FVC \\%","confidence":0.9887876510620117,"confidence_rate":0.999867353725714},{"cnt":[[305,1186],[1772,1186],[1772,1235],[305,1235]],"region":{"top_left_x":305,"top_left_y":1185,"width":1468,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"055ee99d0ff64c07bb701aef4432ab16","type":"text","conversion_output":true,"text":"predicted at Day 57. Furthermore, 6 out of 14 PRM-151 treated subjects experienced a","text_display":" predicted at Day 57. Furthermore, 6 out of 14 PRM-151 treated subjects experienced a","confidence":0.99951171875,"confidence_rate":0.9999948589553403},{"cnt":[[305,1238],[1751,1238],[1751,1287],[305,1287]],"region":{"top_left_x":305,"top_left_y":1237,"width":1446,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62215376a34940d4960d7df30b41c861","type":"text","conversion_output":true,"text":"relative improvement of at least \\(5 \\%\\) from Baseline in FVC \\% predicted. These results","text_display":" relative improvement of at least \\(5 \\%\\) from Baseline in FVC \\% predicted. These results","confidence":0.9902389049530029,"confidence_rate":0.9998922140858939},{"cnt":[[305,1291],[1727,1291],[1727,1338],[305,1338]],"region":{"top_left_x":305,"top_left_y":1291,"width":1423,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5026a66ed3d54db093b20230886b5755","type":"text","conversion_output":true,"text":"seen at 8 weeks post-Baseline after 5 PRM-151 doses administered over 2 weeks are","text_display":" seen at 8 weeks post-Baseline after 5 PRM-151 doses administered over 2 weeks are","confidence":1,"confidence_rate":1},{"cnt":[[305,1341],[1798,1341],[1798,1392],[305,1392]],"region":{"top_left_x":305,"top_left_y":1340,"width":1494,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aed3377aab914f8681d4b357ff10d5e5","type":"text","conversion_output":true,"text":"encouraging, particularly considering that the best result with pirfenidone and nintedanib","text_display":" encouraging, particularly considering that the best result with pirfenidone and nintedanib","confidence":1,"confidence_rate":1},{"cnt":[[305,1394],[1772,1394],[1772,1446],[305,1446]],"region":{"top_left_x":305,"top_left_y":1394,"width":1468,"height":52},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1c936270d2f4553a3af6b7d00c82108","type":"text","conversion_output":true,"text":"is a reduction in the rate of decline rather than improvement in FVC (King, Bradford et","text_display":" is a reduction in the rate of decline rather than improvement in FVC (King, Bradford et","confidence":1,"confidence_rate":1},{"cnt":[[305,1446],[1755,1446],[1755,1497],[305,1497]],"region":{"top_left_x":305,"top_left_y":1445,"width":1451,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e85ee7c020e47ab98d456e173fbf552","type":"text","conversion_output":true,"text":"al.; Richeldi, du Bois et al.). Improvements from Baseline were also observed in FVC","text_display":" al.; Richeldi, du Bois et al.). Improvements from Baseline were also observed in FVC","confidence":1,"confidence_rate":1},{"cnt":[[305,1497],[1800,1497],[1800,1549],[305,1549]],"region":{"top_left_x":305,"top_left_y":1497,"width":1496,"height":53},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0bc1127129e14e31ad19ffd552f82b5b","type":"text","conversion_output":true,"text":"measured in milliliters and in 6MWT distance for PRM-151-treated subjects. Review of","text_display":" measured in milliliters and in 6MWT distance for PRM-151-treated subjects. 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No SAEs were observed over 57 days, and","text_display":" and well tolerated in subjects with IPF. No SAEs were observed over 57 days, and","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[305,1654],[1811,1654],[1811,1704],[305,1704]],"region":{"top_left_x":305,"top_left_y":1654,"width":1507,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b32f4e2804954a2992eaa34f3db0c42e","type":"text","conversion_output":true,"text":"similar types and number of TEAEs were reported in both PRM-151- and placebo-treated","text_display":" similar types and number of TEAEs were reported in both PRM-151- and placebo-treated","confidence":0.9990234375,"confidence_rate":0.9999890220866866},{"cnt":[[305,1706],[458,1706],[458,1755],[305,1755]],"region":{"top_left_x":305,"top_left_y":1705,"width":153,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25773c8d4380484c930c50404c5e355d","type":"text","conversion_output":true,"text":"subjects.","text_display":" subjects.","confidence":1,"confidence_rate":1},{"cnt":[[305,1779],[1760,1779],[1760,1828],[305,1828]],"region":{"top_left_x":305,"top_left_y":1778,"width":1455,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"368f8a2978a94e9989c7682433c5046c","type":"text","conversion_output":true,"text":"Based on these encouraging data in a small cohort of subjects with IPF, Promedior has","text_display":"\n\nBased on these encouraging data in a small cohort of subjects with IPF, Promedior has","confidence":1,"confidence_rate":1},{"cnt":[[305,1830],[1760,1830],[1760,1882],[305,1882]],"region":{"top_left_x":305,"top_left_y":1830,"width":1455,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6af5a8614a2492b92d1eb3fe42e78ee","type":"text","conversion_output":true,"text":"planned to investigate the effects of PRM-151 in the proposed study involving a larger","text_display":" planned to investigate the effects of PRM-151 in the proposed study involving a larger","confidence":1,"confidence_rate":1},{"cnt":[[305,1882],[1016,1882],[1016,1936],[305,1936]],"region":{"top_left_x":305,"top_left_y":1882,"width":712,"height":54},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d5bbfd7885249c1921bb566c14282b4","type":"text","conversion_output":true,"text":"population of subjects with this condition.","text_display":" population of subjects with this condition.","confidence":1,"confidence_rate":1},{"cnt":[[305,1946],[1025,1946],[1025,2004],[305,2004]],"region":{"top_left_x":305,"top_left_y":1946,"width":720,"height":59},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fad8eb0bb4124c87bfa400e14fc7514b","type":"section_header","conversion_output":false,"children_ids":["b419081b9f03427eb6750f47a1fedfde"],"text":"","text_display":""},{"cnt":[[309,1951],[1021,1951],[1021,2000],[309,2000]],"region":{"top_left_x":309,"top_left_y":1950,"width":712,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b419081b9f03427eb6750f47a1fedfde","type":"text","conversion_output":true,"parent_id":"fad8eb0bb4124c87bfa400e14fc7514b","text":"1.5. Risk/Benefit Assessment","text_display":"\n\n\\subsection*{1.5. Risk/Benefit Assessment}","confidence":0.52197265625,"confidence_rate":0.980491586314344},{"cnt":[[305,2030],[1790,2030],[1790,2082],[305,2082]],"region":{"top_left_x":305,"top_left_y":2030,"width":1485,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b33a8b55d2f246a48b8ed97f4d5e32c0","type":"text","conversion_output":true,"text":"PRM-151, a recombinant form of an endogenous human protein, has been well tolerated","text_display":"\n\nPRM-151, a recombinant form of an endogenous human protein, has been well tolerated","confidence":0.99951171875,"confidence_rate":0.999994450009741},{"cnt":[[305,2082],[1738,2082],[1738,2133],[305,2133]],"region":{"top_left_x":305,"top_left_y":2081,"width":1434,"height":53},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"419c7c37730141478a706a13528aa31d","type":"text","conversion_output":true,"text":"in preclinical toxicology studies and Phase 1 and 2 clinical studies, and has shown an","text_display":" in preclinical toxicology studies and Phase 1 and 2 clinical studies, and has shown an","confidence":1,"confidence_rate":1},{"cnt":[[305,2133],[1790,2133],[1790,2185],[305,2185]],"region":{"top_left_x":305,"top_left_y":2133,"width":1485,"height":52},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7f3b36d9641348c38b562fb1e01a005b","type":"text","conversion_output":true,"text":"early trend towards efficacy in subjects with IPF. Based on encouraging Phase 1 data in","text_display":" early trend towards efficacy in subjects with IPF. Based on encouraging Phase 1 data in","confidence":1,"confidence_rate":1},{"cnt":[[305,2185],[1768,2185],[1768,2237],[305,2237]],"region":{"top_left_x":305,"top_left_y":2184,"width":1464,"height":53},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0b2a63321699474088fe636bfbd305b6","type":"text","conversion_output":true,"text":"subjects with IPF, PRM-151 has the potential to be a safe, disease modifying treatment","text_display":" subjects with IPF, PRM-151 has the potential to be a safe, disease modifying treatment","confidence":0.9985356330871582,"confidence_rate":0.9999838963917971},{"cnt":[[305,2239],[1246,2239],[1246,2288],[305,2288]],"region":{"top_left_x":305,"top_left_y":2238,"width":942,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"28c1241e51844eed9a693fcd31600f6e","type":"text","conversion_output":true,"text":"for a broad spectrum of fibrotic diseases, including IPF.","text_display":" for a broad spectrum of fibrotic diseases, including IPF.","confidence":1,"confidence_rate":1},{"cnt":[[305,2312],[1751,2312],[1751,2361],[305,2361]],"region":{"top_left_x":305,"top_left_y":2311,"width":1446,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"791f42bd412c45249c1c9b54e012827e","type":"text","conversion_output":true,"text":"PRM-151 represents the recombinant version of an endogenous human serum protein,","text_display":"\n\nPRM-151 represents the recombinant version of an endogenous human serum protein,","confidence":1,"confidence_rate":1},{"cnt":[[305,2363],[1815,2363],[1815,2413],[305,2413]],"region":{"top_left_x":305,"top_left_y":2363,"width":1511,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1bd5782c9ed147b9aba5b2c4a3fd5b0e","type":"text","conversion_output":true,"text":"and as such was predicted to have a very favorable safety index. This prediction has been","text_display":" and as such was predicted to have a very favorable safety index. This prediction has been","confidence":1,"confidence_rate":1},{"cnt":[[305,2415],[1742,2415],[1742,2464],[305,2464]],"region":{"top_left_x":305,"top_left_y":2414,"width":1438,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a997186508014e7194c03de025b7638d","type":"text","conversion_output":true,"text":"confirmed in multiple preclinical and clinical studies to date. Two Phase 1 studies of","text_display":" confirmed in multiple preclinical and clinical studies to date. Two Phase 1 studies of","confidence":1,"confidence_rate":1},{"cnt":[[1038,2557],[1089,2557],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2556,"width":53,"height":38},"line":45,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3f9ecf6761e14405bca52abd74d470d6","type":"page_info","conversion_output":false,"text":"26","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"05532668-04bd-4780-8ef0-43abd30e1f06-27","page":27,"lines":[{"cnt":[[305,138],[449,138],[449,174],[305,174]],"region":{"top_left_x":305,"top_left_y":137,"width":145,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"728252bfeea344e68efe45395fb2f483","type":"page_info","conversion_output":false,"text":"PRM-151","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,189],[733,189],[733,230],[309,230]],"region":{"top_left_x":309,"top_left_y":189,"width":424,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"70d93a8973804c72a0f54369a344fe57","type":"page_info","conversion_output":false,"text":"Study Protocol PRM-151-202","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1650,189],[1820,189],[1820,226],[1650,226]],"region":{"top_left_x":1650,"top_left_y":189,"width":170,"height":37},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d3614da8d464444e948d11b8a03060bc","type":"page_info","conversion_output":false,"text":"Version 4.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,288],[1772,288],[1772,339],[305,339]],"region":{"top_left_x":305,"top_left_y":287,"width":1468,"height":53},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7910bd4ab7fd4f22bc648cacc0b0d269","type":"text","conversion_output":true,"text":"PRM-151 administered IV to normal volunteers and IPF subjects have been completed,","text_display":"\n\nPRM-151 administered IV to normal volunteers and IPF subjects have been completed,","confidence":1,"confidence_rate":1},{"cnt":[[305,339],[1798,339],[1798,391],[305,391]],"region":{"top_left_x":305,"top_left_y":339,"width":1494,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a960b294675a4beabf21e2b364fc29ca","type":"text","conversion_output":true,"text":"with no SAEs reported and no other safety signals seen. The single ascending dose study","text_display":" with no SAEs reported and no other safety signals seen. The single ascending dose study","confidence":1,"confidence_rate":1},{"cnt":[[305,391],[1781,391],[1781,445],[305,445]],"region":{"top_left_x":305,"top_left_y":391,"width":1477,"height":54},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3f3747bc500549f8945907ab70353bc7","type":"text","conversion_output":true,"text":"(PRM151A-11EU) tested dose levels as high as \\(20 mg / kg\\). The multiple ascending dose","text_display":" (PRM151A-11EU) tested dose levels as high as \\(20 mg / kg\\). The multiple ascending dose","confidence":1,"confidence_rate":1},{"cnt":[[305,443],[1727,443],[1727,496],[305,496]],"region":{"top_left_x":305,"top_left_y":442,"width":1423,"height":55},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4353651939614c2ea58dfa3695be898d","type":"text","conversion_output":true,"text":"study (PRM151F-12GL) demonstrated that PRM-151 administered by 30 -minute IV","text_display":" study (PRM151F-12GL) demonstrated that PRM-151 administered by 30 -minute IV","confidence":0.9990234375,"confidence_rate":0.9999883686432659},{"cnt":[[305,494],[1691,494],[1691,548],[305,548]],"region":{"top_left_x":305,"top_left_y":494,"width":1386,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a81c8ef1ae34cc8a63b4142e87fb8fd","type":"text","conversion_output":true,"text":"infusion on Days \\(1,3,5,8\\) and 15 at up to \\(10 mg / kg\\) was safe and well tolerated in","text_display":" infusion on Days \\(1,3,5,8\\) and 15 at up to \\(10 mg / kg\\) was safe and well tolerated in","confidence":0.7490234375,"confidence_rate":0.9970852158093733},{"cnt":[[305,546],[1764,546],[1764,599],[305,599]],"region":{"top_left_x":305,"top_left_y":545,"width":1459,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2401ab3c95244a58b50303c2da1e2d26","type":"text","conversion_output":true,"text":"subjects with IPF, with no SAEs noted in 57 days; similar types and number of TEAEs","text_display":" subjects with IPF, with no SAEs noted in 57 days; similar types and number of TEAEs","confidence":1,"confidence_rate":1},{"cnt":[[305,597],[1689,597],[1689,651],[305,651]],"region":{"top_left_x":305,"top_left_y":597,"width":1384,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"93422ea62deb492ebf4caa18b4c5db6f","type":"text","conversion_output":true,"text":"were reported in both PRM-151 and placebo treated subjects. Safety data from 27","text_display":" were reported in both PRM-151 and placebo treated subjects. Safety data from 27","confidence":1,"confidence_rate":1},{"cnt":[[305,653],[1775,653],[1775,707],[305,707]],"region":{"top_left_x":305,"top_left_y":653,"width":1470,"height":54},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc3454c8c2ed4022b6b3d115277bd181","type":"text","conversion_output":true,"text":"subjects with MF, including 24 weeks of safety data in 20 subjects and an additional 12","text_display":" subjects with MF, including 24 weeks of safety data in 20 subjects and an additional 12","confidence":1,"confidence_rate":1},{"cnt":[[305,707],[1725,707],[1725,758],[305,758]],"region":{"top_left_x":305,"top_left_y":706,"width":1421,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"05cff2ae9ead4dffb76f15285a21046c","type":"text","conversion_output":true,"text":"weeks of safety data in 10, confirms the excellent safety profile of PRM-151 to date.","text_display":" weeks of safety data in 10, confirms the excellent safety profile of PRM-151 to date.","confidence":0.9791069030761719,"confidence_rate":0.9997654225596267},{"cnt":[[305,756],[1772,756],[1772,810],[305,810]],"region":{"top_left_x":305,"top_left_y":756,"width":1468,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bb795727a8634eb0b2cf0bf6b417b652","type":"text","conversion_output":true,"text":"Most adverse events have been Grade 1 or 2 and unrelated to PRM-151, and 5 possibly","text_display":" Most adverse events have been Grade 1 or 2 and unrelated to PRM-151, and 5 possibly","confidence":1,"confidence_rate":1},{"cnt":[[305,810],[1687,810],[1687,862],[305,862]],"region":{"top_left_x":305,"top_left_y":809,"width":1382,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec689cad57d54c6d872237b0d392af24","type":"text","conversion_output":true,"text":"related SAEs, including one death, have been reported in a group of older subjects","text_display":" related SAEs, including one death, have been reported in a group of older subjects","confidence":1,"confidence_rate":1},{"cnt":[[305,862],[1343,862],[1343,913],[305,913]],"region":{"top_left_x":305,"top_left_y":861,"width":1038,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bc112c226da641cd97f39196ccc9ab4a","type":"text","conversion_output":true,"text":"(median age 67 years) with a serious, life threatening disease.","text_display":" (median age 67 years) with a serious, life threatening disease.","confidence":1,"confidence_rate":1},{"cnt":[[305,935],[1704,935],[1704,986],[305,986]],"region":{"top_left_x":305,"top_left_y":934,"width":1399,"height":53},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"44ecdad1efe44f1386a16561e58d8c8d","type":"text","conversion_output":true,"text":"Risks associated with PRM-151 are inherent in its being the recombinant form of a","text_display":"\n\nRisks associated with PRM-151 are inherent in its being the recombinant form of a","confidence":0.99951171875,"confidence_rate":0.9999943209405665},{"cnt":[[305,986],[1734,986],[1734,1038],[305,1038]],"region":{"top_left_x":305,"top_left_y":986,"width":1429,"height":52},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca380efb7bee481da282825e8acf2fde","type":"text","conversion_output":true,"text":"naturally occurring human protein, and consist of potential development of anti-drug","text_display":" naturally occurring human protein, and consist of potential development of anti-drug","confidence":1,"confidence_rate":1},{"cnt":[[305,1040],[1678,1040],[1678,1089],[305,1089]],"region":{"top_left_x":305,"top_left_y":1039,"width":1373,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1245e77640b8468aa4755dfd871074f8","type":"text","conversion_output":true,"text":"antibodies and infusion reactions. PRM-151 has an endogenous counterpart, and,","text_display":" antibodies and infusion reactions. PRM-151 has an endogenous counterpart, and,","confidence":1,"confidence_rate":1},{"cnt":[[305,1091],[1794,1091],[1794,1141],[305,1141]],"region":{"top_left_x":305,"top_left_y":1091,"width":1489,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f42f1f31fb2449e5a55a9947599c944e","type":"text","conversion_output":true,"text":"therefore, anti-drug antibodies could develop that could potentially affect the efficacy of","text_display":" therefore, anti-drug antibodies could develop that could potentially affect the efficacy of","confidence":1,"confidence_rate":1},{"cnt":[[305,1143],[1766,1143],[1766,1192],[305,1192]],"region":{"top_left_x":305,"top_left_y":1142,"width":1462,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec8c5e0eb39c46b58bf6d87f3a5adf4e","type":"text","conversion_output":true,"text":"PRM-151 treatments in addition to having the potential to cross-react with endogenous","text_display":" PRM-151 treatments in addition to having the potential to cross-react with endogenous","confidence":1,"confidence_rate":1},{"cnt":[[305,1195],[1687,1195],[1687,1244],[305,1244]],"region":{"top_left_x":305,"top_left_y":1194,"width":1382,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"397a3674b73446f6a2908ce412042593","type":"text","conversion_output":true,"text":"hPTX-2. Anti-drug antibodies were detected in 3 subjects in the MF trial, with no","text_display":" hPTX-2. Anti-drug antibodies were detected in 3 subjects in the MF trial, with no","confidence":1,"confidence_rate":1},{"cnt":[[305,1246],[1671,1246],[1671,1300],[305,1300]],"region":{"top_left_x":305,"top_left_y":1246,"width":1367,"height":54},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0d81384d3da14d75bfe03e13863e1396","type":"text","conversion_output":true,"text":"apparent impact on pharmacokinetics, safety, or efficacy. Two subjects had mild","text_display":" apparent impact on pharmacokinetics, safety, or efficacy. 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Pregnancy testing should be","confidence":1,"confidence_rate":1},{"cnt":[[305,1955],[1304,1955],[1304,2007],[305,2007]],"region":{"top_left_x":305,"top_left_y":1955,"width":1000,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6abc83c40b3c407491f2f3eb001c5658","type":"text","conversion_output":true,"text":"repeated during treatment any time pregnancy is suspected.","text_display":" repeated during treatment any time pregnancy is suspected.","confidence":1,"confidence_rate":1},{"cnt":[[305,2028],[1794,2028],[1794,2078],[305,2078]],"region":{"top_left_x":305,"top_left_y":2028,"width":1489,"height":50},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cd6ebf55adf746fc89dd4b972e5912d7","type":"text","conversion_output":true,"text":"During Screening, results must be reviewed and confirmed to be negative for the subject","text_display":"\n\nDuring Screening, results must be reviewed and confirmed to be negative for the subject","confidence":1,"confidence_rate":1},{"cnt":[[305,2080],[1779,2080],[1779,2129],[305,2129]],"region":{"top_left_x":305,"top_left_y":2079,"width":1474,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9129e2839a0848dba288418727a34414","type":"text","conversion_output":true,"text":"to be eligible for enrollment in the study. 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Weight is to be measured throughout the study for use in","text_display":"\nof height during Screening. Weight is to be measured throughout the study for use in","confidence":1,"confidence_rate":1},{"cnt":[[305,335],[840,335],[840,385],[305,385]],"region":{"top_left_x":305,"top_left_y":335,"width":536,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65de3a2a0bb44b5ca8ff1e98c5e0eb92","type":"text","conversion_output":true,"text":"weight based dose calculations.","text_display":" weight based dose calculations.","confidence":1,"confidence_rate":1},{"cnt":[[305,408],[1674,408],[1674,458],[305,458]],"region":{"top_left_x":305,"top_left_y":408,"width":1369,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c537572f49c4245b32610f196d5f1e8","type":"text","conversion_output":true,"text":"Complete physical examinations also will include a review of the following body","text_display":"\n\nComplete physical examinations also will include a review of the following body","confidence":1,"confidence_rate":1},{"cnt":[[305,464],[458,464],[458,509],[305,509]],"region":{"top_left_x":305,"top_left_y":464,"width":153,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56dce8e74c8a448691f702e64a53b872","type":"text","conversion_output":true,"text":"systems:","text_display":" systems:","confidence":1,"confidence_rate":1},{"cnt":[[434,533],[844,533],[844,582],[434,582]],"region":{"top_left_x":433,"top_left_y":532,"width":412,"height":51},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb913c08b8d440d2b15ed67b4577f420","type":"text","conversion_output":true,"text":"- General appearance.","text_display":"\n- General appearance.","confidence":0.9990234375,"confidence_rate":0.9999624222580676},{"cnt":[[432,606],[1070,606],[1070,655],[432,655]],"region":{"top_left_x":431,"top_left_y":605,"width":639,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"19ee6dad282b454aae16798306c862b2","type":"text","conversion_output":true,"text":"- Head, eyes, ears, nose, and throat.","text_display":"\n- Head, eyes, ears, nose, and throat.","confidence":1,"confidence_rate":1},{"cnt":[[434,677],[707,677],[707,726],[434,726]],"region":{"top_left_x":433,"top_left_y":676,"width":274,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"87e9fbbbbf894865b2de113a7bafbb8b","type":"text","conversion_output":true,"text":"- Respiratory.","text_display":"\n- Respiratory.","confidence":1,"confidence_rate":1},{"cnt":[[434,748],[765,748],[765,793],[434,793]],"region":{"top_left_x":433,"top_left_y":747,"width":332,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc7a249874c9423e97257e612dc655e6","type":"text","conversion_output":true,"text":"- Cardiovascular.","text_display":"\n- Cardiovascular.","confidence":1,"confidence_rate":1},{"cnt":[[434,821],[677,821],[677,862],[434,862]],"region":{"top_left_x":433,"top_left_y":820,"width":244,"height":42},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d1cda67eb3f3457aa2f05ca033d4065f","type":"text","conversion_output":true,"text":"- Abdomen.","text_display":"\n- Abdomen.","confidence":0.9936552047729492,"confidence_rate":0.9995757560844373},{"cnt":[[434,889],[698,889],[698,939],[434,939]],"region":{"top_left_x":433,"top_left_y":889,"width":266,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7686b28ced0f4838a4fd554a5ec711d6","type":"text","conversion_output":true,"text":"- Neurologic.","text_display":"\n- Neurologic.","confidence":1,"confidence_rate":1},{"cnt":[[434,962],[707,962],[707,1008],[434,1008]],"region":{"top_left_x":433,"top_left_y":962,"width":274,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e6416ded1274431ac7040ed48c611e0","type":"text","conversion_output":true,"text":"- Extremities.","text_display":"\n- Extremities.","confidence":1,"confidence_rate":1},{"cnt":[[434,1036],[741,1036],[741,1085],[434,1085]],"region":{"top_left_x":433,"top_left_y":1035,"width":309,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b71973fbdf3c4fccb859c567751be5d0","type":"text","conversion_output":true,"text":"- Dermatologic.","text_display":"\n- Dermatologic.","confidence":1,"confidence_rate":1},{"cnt":[[305,1104],[1807,1104],[1807,1154],[305,1154]],"region":{"top_left_x":305,"top_left_y":1104,"width":1502,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a17e4614df814deaac34d5fce89b6d2c","type":"text","conversion_output":true,"text":"Full physical examinations are to be performed at screening; Abbreviated physical exams","text_display":"\n\nFull physical examinations are to be performed at screening; Abbreviated physical exams","confidence":1,"confidence_rate":1},{"cnt":[[305,1154],[823,1154],[823,1201],[305,1201]],"region":{"top_left_x":305,"top_left_y":1153,"width":518,"height":48},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c3ed52dd382d4719924f74fbdf0a9842","type":"text","conversion_output":true,"text":"are to be performed thereafter.","text_display":" are to be performed thereafter.","confidence":1,"confidence_rate":1},{"cnt":[[307,1222],[1463,1222],[1463,1270],[307,1270]],"region":{"top_left_x":307,"top_left_y":1222,"width":1157,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc9a7e2c66f84870b6b53952db16f5da","type":"text","conversion_output":true,"text":"The findings of each examination are to be documented in the eCRF.","text_display":"\n\nThe findings of each examination are to be documented in the eCRF.","confidence":1,"confidence_rate":1},{"cnt":[[305,1293],[1772,1293],[1772,1343],[305,1343]],"region":{"top_left_x":305,"top_left_y":1293,"width":1468,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fc9c5a7b53234bc4a10328296c120b1d","type":"text","conversion_output":true,"text":"If an abnormality noted on physical examination is considered by the Investigator to be","text_display":"\nIf an abnormality noted on physical examination is considered by the Investigator to be","confidence":0.99951171875,"confidence_rate":0.9999946913130248},{"cnt":[[305,1345],[1695,1345],[1695,1396],[305,1396]],"region":{"top_left_x":305,"top_left_y":1344,"width":1391,"height":53},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"120fde0cd3dc4bceb3c3a7c00e1be4d4","type":"text","conversion_output":true,"text":"clinically significant, then the abnormality is to be recorded as part of the subject's","text_display":" clinically significant, then the abnormality is to be recorded as part of the subject's","confidence":1,"confidence_rate":1},{"cnt":[[305,1399],[1749,1399],[1749,1448],[305,1448]],"region":{"top_left_x":305,"top_left_y":1398,"width":1444,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34cf90c6f8dc4f779fe1ff7efd103a17","type":"text","conversion_output":true,"text":"medical history if occurring prior to start of dosing and as an AE occurring if after the","text_display":" medical history if occurring prior to start of dosing and as an AE occurring if after the","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[307,1452],[1794,1452],[1794,1502],[307,1502]],"region":{"top_left_x":307,"top_left_y":1452,"width":1487,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8082b6fe8014506ad3874822c8ff2ad","type":"text","conversion_output":true,"text":"start of study drug administration at Week 0 , where the finding represents a change from","text_display":" start of study drug administration at Week 0 , where the finding represents a change from","confidence":0.880859375,"confidence_rate":0.9986930477395913},{"cnt":[[305,1504],[1732,1504],[1732,1553],[305,1553]],"region":{"top_left_x":305,"top_left_y":1503,"width":1427,"height":51},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36b39fcc9ba4452d9af74f5c32e0f44a","type":"text","conversion_output":true,"text":"Baseline. 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Vital Signs","text_display":"\n\n\\subsection*{7.8. 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Severity & Definition \\\\\n\\hline Grade 1 (Mild): & Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. \\\\\n\\hline Grade 2 (Moderate): & Moderate; minimal, local or noninvasive intervention indicated; limiting ageappropriate instrumental ADL. \\\\\n\\hline Grade 3 (Severe): & Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. \\\\\n\\hline Grade 4 (Life-threatening): & Life-threatening consequences; urgent intervention indicated. \\\\\n\\hline Grade 5 (Death): & Death related to AE. \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 7-2: Adverse Event Grading}\n\\begin{tabular}{|l|l|}\n\\hline Severity & Definition \\\\\n\\hline Grade 1 (Mild): & Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not 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Nevertheless, the sample-size has been calculated to ensure a","text_display":" to as the primary endpoint. 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Analyses of quantitative primary, secondary and exploratory efficacy","text_display":"\n\n\\subsection*{8.5.1.3.2. 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This analysis will be conducted on the FAS for","text_display":" to adjust for correlated errors over time. This analysis will be conducted on the FAS for","confidence":1,"confidence_rate":1},{"cnt":[[305,2320],[1729,2320],[1729,2370],[305,2370]],"region":{"top_left_x":305,"top_left_y":2320,"width":1425,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7acabea75cd94429b713bfc526404d4c","type":"text","conversion_output":true,"text":"all secondary and exploratory efficacy endpoints and on both the FAS and PP set for","text_display":" all secondary and exploratory efficacy endpoints and on both the FAS and PP set for","confidence":1,"confidence_rate":1},{"cnt":[[305,2368],[617,2368],[617,2417],[305,2417]],"region":{"top_left_x":305,"top_left_y":2367,"width":312,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd12acbf043146b4b8d35e2bfa390f53","type":"text","conversion_output":true,"text":"FVC \\% predicted.","text_display":" FVC \\% predicted.","confidence":1,"confidence_rate":1},{"cnt":[[1038,2557],[1089,2557],[1089,2593],[1038,2593]],"region":{"top_left_x":1037,"top_left_y":2556,"width":53,"height":38},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"324d7052434a4bc0a88f51f12b74d434","type":"page_info","conversion_output":false,"text":"56","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"05532668-04bd-4780-8ef0-43abd30e1f06-57","page":57,"lines":[{"cnt":[[309,138],[449,138],[449,174],[309,174]],"region":{"top_left_x":309,"top_left_y":137,"width":141,"height":38},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3813adb6faf74b339153213ecbff285e","type":"page_info","conversion_output":false,"text":"PRM-151","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[309,189],[733,189],[733,230],[309,230]],"region":{"top_left_x":309,"top_left_y":189,"width":424,"height":41},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c5d8b4c45d934f6b9cdaeafd39bd1598","type":"page_info","conversion_output":false,"text":"Study Protocol PRM-151-202","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1650,189],[1820,189],[1820,226],[1650,226]],"region":{"top_left_x":1650,"top_left_y":189,"width":170,"height":37},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"0438cb03c38f427983f503bc56ad9cd2","type":"page_info","conversion_output":false,"text":"Version 4.0","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[305,288],[1691,288],[1691,342],[305,342]],"region":{"top_left_x":305,"top_left_y":287,"width":1386,"height":55},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"985060c132824ef1a1db50d7e260c377","type":"text","conversion_output":true,"text":"8.5.1.3.3. 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(2004). \"Autoimmunity and glomerulonephritis","confidence":0.99951171875,"confidence_rate":0.9999946329759618},{"cnt":[[434,1190],[1721,1190],[1721,1235],[434,1235]],"region":{"top_left_x":433,"top_left_y":1190,"width":1288,"height":46},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea403c034e87436a9089fa76fbb898f4","type":"text","conversion_output":true,"text":"in mice with targeted deletion of the serum amyloid P component gene: SAP","text_display":" in mice with targeted deletion of the serum amyloid P component gene: SAP","confidence":0.7234060764312744,"confidence_rate":0.9961528412588512},{"cnt":[[434,1231],[1536,1231],[1536,1278],[434,1278]],"region":{"top_left_x":433,"top_left_y":1231,"width":1104,"height":48},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"209d7b03c85344fea03eda3bc0f94d0d","type":"text","conversion_output":true,"text":"deficiency or strain combination?\" Immunology 112(2): 255-264.","text_display":" deficiency or strain combination?\" Immunology 112(2): 255-264.","confidence":1,"confidence_rate":1},{"cnt":[[309,1293],[1777,1293],[1777,1338],[309,1338]],"region":{"top_left_x":309,"top_left_y":1293,"width":1468,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e993ac064713495a9219cc135f6254cd","type":"text","conversion_output":true,"text":"Gomer, R. H. and M. L. Lupher, Jr. (2010). \"Investigational approaches to therapies for","text_display":"\nGomer, R. H. and M. L. Lupher, Jr. (2010). \"Investigational approaches to therapies for","confidence":1,"confidence_rate":1},{"cnt":[[434,1336],[1687,1336],[1687,1381],[434,1381]],"region":{"top_left_x":433,"top_left_y":1336,"width":1254,"height":46},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a49361d33deb4e62ac5a94c8a4ff9081","type":"text","conversion_output":true,"text":"idiopathic pulmonary fibrosis.\" Expert Opin Investig Drugs 19(6): 737-45.","text_display":" idiopathic pulmonary fibrosis.\" Expert Opin Investig Drugs 19(6): 737-45.","confidence":1,"confidence_rate":1},{"cnt":[[309,1396],[1807,1396],[1807,1446],[309,1446]],"region":{"top_left_x":309,"top_left_y":1396,"width":1498,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fbab6085bfe41c984499d06413942c3","type":"text","conversion_output":true,"text":"Haudek, S. B., Y. Xia, et al. (2006). \"Bone marrow-derived fibroblast precursors mediate","text_display":"\nHaudek, S. B., Y. Xia, et al. (2006). \"Bone marrow-derived fibroblast precursors mediate","confidence":1,"confidence_rate":1},{"cnt":[[434,1439],[1790,1439],[1790,1487],[434,1487]],"region":{"top_left_x":433,"top_left_y":1439,"width":1357,"height":48},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"271d420cf50949c38abe696e843a2c0f","type":"text","conversion_output":true,"text":"ischemic cardiomyopathy in mice.\" Proc Natl Acad Sci U S A 103(48): 18284-9.","text_display":" ischemic cardiomyopathy in mice.\" Proc Natl Acad Sci U S A 103(48): 18284-9.","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[309,1502],[1751,1502],[1751,1549],[309,1549]],"region":{"top_left_x":309,"top_left_y":1501,"width":1442,"height":49},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6868fca7d0c74a899df1425f18003a7c","type":"text","conversion_output":true,"text":"Hawkins, P. N., R. Wootton, et al. (1990). \"Metabolic studies of radioiodinated serum","text_display":"\nHawkins, P. N., R. Wootton, et al. (1990). \"Metabolic studies of radioiodinated serum","confidence":1,"confidence_rate":1},{"cnt":[[434,1543],[1811,1543],[1811,1590],[434,1590]],"region":{"top_left_x":433,"top_left_y":1542,"width":1379,"height":48},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5bc61304bf144596996b7a2e240bfa94","type":"text","conversion_output":true,"text":"amyloid P component in normal subjects and patients with systemic amyloidosis.\"","text_display":" amyloid P component in normal subjects and patients with systemic amyloidosis.\"","confidence":0.9416444301605225,"confidence_rate":0.9993321393589609},{"cnt":[[434,1586],[900,1586],[900,1631],[434,1631]],"region":{"top_left_x":433,"top_left_y":1585,"width":468,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbfe042efab74e03b43185042ecd1550","type":"text","conversion_output":true,"text":"J Clin Invest 86(6): 1862-9.","text_display":" J Clin Invest 86(6): 1862-9.","confidence":1,"confidence_rate":1},{"cnt":[[309,1646],[1691,1646],[1691,1695],[309,1695]],"region":{"top_left_x":309,"top_left_y":1645,"width":1382,"height":51},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36382838d7864308bd813a4fea818387","type":"text","conversion_output":true,"text":"King, T. 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(2012). \"Incidence and prevalence of idiopathic","confidence":1,"confidence_rate":1},{"cnt":[[430,614],[1704,614],[1704,664],[430,664]],"region":{"top_left_x":429,"top_left_y":614,"width":1275,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"135aafe95e534f3e8e1655ad737e042f","type":"text","conversion_output":true,"text":"pulmonary fibrosis: review of the literature.\" European Respiratory Review","text_display":" pulmonary fibrosis: review of the literature.\" European Respiratory Review","confidence":1,"confidence_rate":1},{"cnt":[[430,657],[746,657],[746,707],[430,707]],"region":{"top_left_x":429,"top_left_y":657,"width":317,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4dc5fe1521114ed598b3e6244eb18be1","type":"text","conversion_output":true,"text":"21(126): 355-361.","text_display":" 21(126): 355-361.","confidence":1,"confidence_rate":1},{"cnt":[[305,718],[1676,718],[1676,767],[305,767]],"region":{"top_left_x":305,"top_left_y":717,"width":1371,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a8ecfbb7a35046a8868c33db25dbd5af","type":"text","conversion_output":true,"text":"Navaratnam, V., K. 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\\multirow{3}{*}{} & & \\multicolumn{2}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nWeek 0 \\\\\n(+/-1day)\n\\end{tabular}}} & \\begin{tabular}{l}\nW4, W8, W12, \\\\\nW16, \\\\\nW20,W24 \\\\\n(+/- 3d)\n\\end{tabular} & \\begin{tabular}{l}\nW28/ EOS \\\\\n(+/- 3d)\n\\end{tabular} & \\multicolumn{2}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nW28 \\\\\n(+/- 3d)\n\\end{tabular}}} & \\begin{tabular}{l}\nW32 \\\\\n(+/- 3d)\n\\end{tabular} & \\begin{tabular}{l}\nW36 \\\\\n(+/- 3d)\n\\end{tabular} & W40 & W44 & W48 & W52 & \\multicolumn{2}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nWeek 56 \\\\\n(+/-3days)\n\\end{tabular}}} \\\\\n\\hline & & & & & & & & & & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & \\multicolumn{2}{|c|}{} \\\\\n\\hline & & \\begin{tabular}{l}\nBaseline \\\\\nDosing \\\\\nDay 1\n\\end{tabular} & \\begin{tabular}{l}\nDosing \\\\\nDays \\\\\n3,5\n\\end{tabular} & Dosing Day 1 & & Dosing Day 1 & \\begin{tabular}{l}\nDosing \\\\\nDays \\\\\n3, 5\n\\end{tabular} & Dosing Day 1 & Dosing Day 1 & & & & & Baseline Dosing Day 1 & Dosing Days 3, 5 \\\\\n\\hline Informed Consent & x & & & & & & & & & & & & & & \\\\\n\\hline Demographics & x & & & & & & & & & & & & & & \\\\\n\\hline Past Medical History & x & & & & & & & & & & & & & & \\\\\n\\hline Inclusion/Exclusion & x & x & & & & & & & & & & & & & \\\\\n\\hline Vital Signs (pre and post dose and every 15 minutes for the duration of the infusion & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Physical Exam[1] & x & x & & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Height (cm) & x & & & & & & & & & & & & & & \\\\\n\\hline Weight (kg) & x & x & & x & & x & x & x & x & x & x & x & x & x & \\\\\n\\hline Prior/Concomitant Medications & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Special list of excluded medications & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline AE/SAE Assessment & & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline ECG \\& Cytokines (ONLY in the event of an IRR after Baseline) & & x & x & x & & & x & x & x & x & x & x & x & x & x \\\\\n\\hline Efficacy Assessment[2] & & & & & & & & & & & & & & & \\\\\n\\hline Patient Reported Outcomes; K-BILD \\& LCQ & x & x & & x & x & x & & x & x & x & x & x & x & & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|l|}\n\\hline \\multirow{3}{*}{} & & \\multicolumn{2}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nWeek 0 \\\\\n(+/-1day)\n\\end{tabular}}} & \\begin{tabular}{l}\nW4, W8, W12, \\\\\nW16, \\\\\nW20,W24 \\\\\n(+/- 3d)\n\\end{tabular} & \\begin{tabular}{l}\nW28/ EOS \\\\\n(+/- 3d)\n\\end{tabular} & \\multicolumn{2}{|c|}{\\multirow{2}{*}{\\begin{tabular}{l}\nW28 \\\\\n(+/- 3d)\n\\end{tabular}}} & \\begin{tabular}{l}\nW32 \\\\\n(+/- 3d)\n\\end{tabular} & \\begin{tabular}{l}\nW36 \\\\\n(+/- 3d)\n\\end{tabular} & W40 & W44 & W48 & W52 & 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\\multirow{3}{*}{} & & W60 & W64 & W68 & W72 & W76 & W80 & \\multicolumn{2}{|c|}{} & W88 & W92 & W96 & W100 & W104 & W108 & \\\\\n\\hline & & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & \\multicolumn{2}{|c|}{(+/-3days)} & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & \\\\\n\\hline & & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Baseline Dosing Day 1 & Dosing Days 3, 5 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Base Dosi Day \\\\\n\\hline Informed Consent & x & & & & & & & & & & & & & & & \\\\\n\\hline Demographics & x & & & & & & & & & & & & & & & \\\\\n\\hline Past Medical History & x & & & & & & & & & & & & & & & \\\\\n\\hline Inclusion/Exclusion & x & & & & & & & & & & & & & & & \\\\\n\\hline Vital Signs (pre and post dose and every 15 minutes for the duration of the infusion & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x 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& & W60 & W64 & W68 & W72 & W76 & W80 & \\multicolumn{2}{|c|}{} & W88 & W92 & W96 & W100 & W104 & W108 & \\\\\n\\hline & & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & \\multicolumn{2}{|c|}{(+/-3days)} & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & (+/- 3d) & \\\\\n\\hline & & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Baseline Dosing Day 1 & Dosing Days 3, 5 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Dosing Day 1 & Base Dosi Day \\\\\n\\hline Informed Consent & x & & & & & & & & & & & & & & & \\\\\n\\hline Demographics & x & & & & & & & & & & & & & & & \\\\\n\\hline Past Medical History & x & & & & & & & & & & & & & & & \\\\\n\\hline Inclusion/Exclusion & x & & & & & & & & & & & & & & & \\\\\n\\hline Vital Signs (pre and post dose and every 15 minutes for the duration of the infusion & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Physical Exam[1] & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Height (cm) & x & & & & & & & & & & & & & & & \\\\\n\\hline Weight (kg) & x & x & x & x & x & x & x & x & & x & x & x & x & x & x & x \\\\\n\\hline Prior/Concomitant Medications & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Special list of excluded medications & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline AE/SAE Assessment & & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline ECG \\& Cytokines (ONLY in the event of an IRR after Baseline) & & x & x & x & x & x & x & x & x & x & x & x & x & x & x & x \\\\\n\\hline Efficacy Assessment[2] & & & & & & & & & & & & & & & & \\\\\n\\hline Patient Reported Outcomes; K-BILD \\& LCQ & x & & x & & & x & & & & x & & & x & & & x 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Complete the","confidence":1,"confidence_rate":1},{"cnt":[[305,412],[810,412],[810,462],[305,462]],"region":{"top_left_x":305,"top_left_y":412,"width":505,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e95dc73c770c4793a5dfac6528c36a01","type":"text","conversion_output":true,"text":"first portion of the worksheet.","text_display":" first portion of the worksheet.","confidence":1,"confidence_rate":1},{"cnt":[[245,466],[1777,466],[1777,513],[245,513]],"region":{"top_left_x":244,"top_left_y":466,"width":1533,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5510d30dc348485399c47c29a8be56aa","type":"text","conversion_output":true,"text":"4. Pulseoximetry is optional. If it is performed, measure and record baseline heart rate and","text_display":"\n4. Pulseoximetry is optional. If it is performed, measure and record baseline heart rate and","confidence":1,"confidence_rate":1},{"cnt":[[307,518],[1863,518],[1863,565],[307,565]],"region":{"top_left_x":307,"top_left_y":517,"width":1556,"height":49},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce815e41a33b4927b1748d252269da53","type":"text","conversion_output":true,"text":"oxygen saturation (SpO2) and follow manufacturer's instructions to maximize the signal and","text_display":" oxygen saturation (SpO2) and follow manufacturer's instructions to maximize the signal and","confidence":0.7889842987060547,"confidence_rate":0.9975082794118424},{"cnt":[[307,571],[1785,571],[1785,617],[307,617]],"region":{"top_left_x":307,"top_left_y":571,"width":1479,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4d59730fed54f5e9236295a28e81264","type":"text","conversion_output":true,"text":"to minimize motion artifact \\((56,57)\\). Make sure the readings are stable before recording.","text_display":" to minimize motion artifact \\((56,57)\\). Make sure the readings are stable before recording.","confidence":0.9766151604708284,"confidence_rate":0.9997560853834612},{"cnt":[[307,623],[1876,623],[1876,668],[307,668]],"region":{"top_left_x":307,"top_left_y":623,"width":1569,"height":46},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"871520de43194c20a26ebbbd1a46a650","type":"text","conversion_output":true,"text":"Note pulse regularity and whether the oximeter signal quality is acceptable. The rationale for","text_display":" Note pulse regularity and whether the oximeter signal quality is acceptable. The rationale for","confidence":1,"confidence_rate":1},{"cnt":[[307,675],[1826,675],[1826,720],[307,720]],"region":{"top_left_x":307,"top_left_y":674,"width":1520,"height":46},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a6ea0a5bef54e7b840563958360de11","type":"text","conversion_output":true,"text":"measuring oxygen saturation is that although the distance is the primary outcome measure,","text_display":" measuring oxygen saturation is that although the distance is the primary outcome measure,","confidence":1,"confidence_rate":1},{"cnt":[[307,726],[1863,726],[1863,776],[307,776]],"region":{"top_left_x":307,"top_left_y":726,"width":1556,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cea336d21e2e4ae3a58241acf20cb760","type":"text","conversion_output":true,"text":"improvement during serial evaluations may be manifest either by an increased distance or by","text_display":" improvement during serial evaluations may be manifest either by an increased distance or by","confidence":1,"confidence_rate":1},{"cnt":[[307,778],[1803,778],[1803,827],[307,827]],"region":{"top_left_x":307,"top_left_y":777,"width":1496,"height":51},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcc71af7c7924834b1025783d398d182","type":"text","conversion_output":true,"text":"reduced symptoms with the same distance walked (39). The SpO 2 should not be used for","text_display":" reduced symptoms with the same distance walked (39). The SpO 2 should not be used for","confidence":0.9868226051330566,"confidence_rate":0.9998603783050994},{"cnt":[[307,829],[1813,829],[1813,879],[307,879]],"region":{"top_left_x":307,"top_left_y":829,"width":1507,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"071c97b1bf9e47e5893021d1afc61592","type":"text","conversion_output":true,"text":"constant monitoring during the exercise. The technician must not walk with the patient to","text_display":" constant monitoring during the exercise. The technician must not walk with the patient to","confidence":1,"confidence_rate":1},{"cnt":[[307,881],[1867,881],[1867,930],[307,930]],"region":{"top_left_x":307,"top_left_y":880,"width":1560,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4c1aa1b0577412dbfa2c16687c2cef4","type":"text","conversion_output":true,"text":"observe the SpO 2 . If worn during the walk, the pulse oximeter must be lightweight (less than","text_display":" observe the SpO 2 . If worn during the walk, the pulse oximeter must be lightweight (less than","confidence":1,"confidence_rate":1},{"cnt":[[305,932],[1863,932],[1863,982],[305,982]],"region":{"top_left_x":305,"top_left_y":932,"width":1558,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90fd13b8b4e146a0a3c57bc6fb7cde8c","type":"text","conversion_output":true,"text":"2 pounds), battery powered, and held in place (perhaps by a \"fanny pack\") so that the patient","text_display":" 2 pounds), battery powered, and held in place (perhaps by a \"fanny pack\") so that the patient","confidence":1,"confidence_rate":1},{"cnt":[[305,986],[1820,986],[1820,1033],[305,1033]],"region":{"top_left_x":305,"top_left_y":986,"width":1515,"height":48},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7ed62cfbd0224836b563b2e05926a823","type":"text","conversion_output":true,"text":"does not have to hold or stabilize it and so that stride is not affected. Many pulseoximeters","text_display":" does not have to hold or stabilize it and so that stride is not affected. Many pulseoximeters","confidence":0.99951171875,"confidence_rate":0.9999950163338663},{"cnt":[[305,1040],[1678,1040],[1678,1085],[305,1085]],"region":{"top_left_x":305,"top_left_y":1039,"width":1373,"height":46},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dae86d4e8ad14b1a8a389aed8b831506","type":"text","conversion_output":true,"text":"have considerable motion artifact that prevents accurate readings during the walk.","text_display":" have considerable motion artifact that prevents accurate readings during the walk.","confidence":1,"confidence_rate":1},{"cnt":[[245,1091],[1790,1091],[1790,1139],[245,1139]],"region":{"top_left_x":244,"top_left_y":1091,"width":1546,"height":48},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c44ffd73ed344769ce5df8f41fa8f57","type":"text","conversion_output":true,"text":"5. Have the patient stand and rate their baseline dyspnea and overall fatigue using the Borg","text_display":"\n5. Have the patient stand and rate their baseline dyspnea and overall fatigue using the Borg","confidence":1,"confidence_rate":1},{"cnt":[[305,1143],[1334,1143],[1334,1190],[305,1190]],"region":{"top_left_x":305,"top_left_y":1142,"width":1030,"height":49},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b0c706cf20914179ab1dc74bb9a32fe2","type":"text","conversion_output":true,"text":"scale (see APPENDIX E for the Borg scale and instructions).","text_display":" scale (see APPENDIX E for the Borg scale and instructions).","confidence":1,"confidence_rate":1},{"cnt":[[245,1195],[1869,1195],[1869,1244],[245,1244]],"region":{"top_left_x":244,"top_left_y":1194,"width":1626,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95cef56322ef4400b9f6a1ca16635443","type":"text","conversion_output":true,"text":"6. Set the lap counter to zero and the timer to 6 minutes. Assemble all necessary equipment (lap","text_display":"\n6. Set the lap counter to zero and the timer to 6 minutes. Assemble all necessary equipment (lap","confidence":1,"confidence_rate":1},{"cnt":[[305,1246],[1656,1246],[1656,1296],[305,1296]],"region":{"top_left_x":305,"top_left_y":1246,"width":1352,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ce39d6f488884ec29a7c24aca48caaf1","type":"text","conversion_output":true,"text":"counter, timer, clipboard, Borg Scale, worksheet) and move to the starting point.","text_display":" counter, timer, clipboard, Borg Scale, worksheet) and move to the starting point.","confidence":1,"confidence_rate":1},{"cnt":[[245,1298],[819,1298],[819,1347],[245,1347]],"region":{"top_left_x":244,"top_left_y":1297,"width":575,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"58b5b0f9d097428db7189d4d248b33c0","type":"text","conversion_output":true,"text":"7. Instruct the patient as follows:","text_display":"\n7. Instruct the patient as follows:","confidence":1,"confidence_rate":1},{"cnt":[[370,1371],[1876,1371],[1876,1420],[370,1420]],"region":{"top_left_x":369,"top_left_y":1370,"width":1507,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"768fde1cc90743e1be1e5f91cf632659","type":"text","conversion_output":true,"text":"\"The object of this test is to walk as far as possible for 6 minutes. You will walk back and","text_display":"\n\"The object of this test is to walk as far as possible for 6 minutes. You will walk back and","confidence":1,"confidence_rate":1},{"cnt":[[370,1422],[1871,1422],[1871,1472],[370,1472]],"region":{"top_left_x":369,"top_left_y":1422,"width":1503,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20d0277ea3624b58a4ab4b330f9758fe","type":"text","conversion_output":true,"text":"forth in this hallway. Six minutes is a long time to walk, so you will be exerting yourself.","text_display":" forth in this hallway. Six minutes is a long time to walk, so you will be exerting yourself.","confidence":1,"confidence_rate":1},{"cnt":[[370,1474],[1790,1474],[1790,1523],[370,1523]],"region":{"top_left_x":369,"top_left_y":1473,"width":1421,"height":51},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6ff7c2e7241742679a0d3e2238f0be5a","type":"text","conversion_output":true,"text":"You will probably get out of breath or become exhausted. You are permitted to slow","text_display":" You will probably get out of breath or become exhausted. You are permitted to slow","confidence":1,"confidence_rate":1},{"cnt":[[370,1525],[1846,1525],[1846,1577],[370,1577]],"region":{"top_left_x":369,"top_left_y":1525,"width":1477,"height":52},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"092c3768046a49e48252c6828959076c","type":"text","conversion_output":true,"text":"down, to stop, and to rest as necessary. You may lean against the wall while resting, but","text_display":" down, to stop, and to rest as necessary. You may lean against the wall while resting, but","confidence":1,"confidence_rate":1},{"cnt":[[370,1577],[1044,1577],[1044,1626],[370,1626]],"region":{"top_left_x":369,"top_left_y":1576,"width":676,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6de67504584d404eb523220a146ba08d","type":"text","conversion_output":true,"text":"resume walking as soon as you are able.","text_display":" resume walking as soon as you are able.","confidence":1,"confidence_rate":1},{"cnt":[[370,1652],[1824,1652],[1824,1702],[370,1702]],"region":{"top_left_x":369,"top_left_y":1652,"width":1456,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f99e924b5a2c48ee93d1073a6ca76421","type":"text","conversion_output":true,"text":"You will be walking back and forth around the cones. You should pivot briskly around","text_display":"\n\nYou will be walking back and forth around the cones. You should pivot briskly around","confidence":1,"confidence_rate":1},{"cnt":[[370,1706],[1815,1706],[1815,1755],[370,1755]],"region":{"top_left_x":369,"top_left_y":1705,"width":1447,"height":51},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94c98cbaf02646839e72ed42a9d5de1b","type":"text","conversion_output":true,"text":"the cones and continue back the other way without hesitation. Now I'm going to show","text_display":" the cones and continue back the other way without hesitation. Now I'm going to show","confidence":0.998046875,"confidence_rate":0.9999777839418279},{"cnt":[[370,1757],[1261,1757],[1261,1807],[370,1807]],"region":{"top_left_x":369,"top_left_y":1757,"width":893,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"339d73c62f554b75b1e03b3c6523ad0b","type":"text","conversion_output":true,"text":"you. Please watch the way I turn without hesitation.\"","text_display":" you. Please watch the way I turn without hesitation.\"","confidence":1,"confidence_rate":1},{"cnt":[[370,1830],[1721,1830],[1721,1880],[370,1880]],"region":{"top_left_x":369,"top_left_y":1830,"width":1352,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2022cdc62a2480b9a89e68200bebcbe","type":"text","conversion_output":true,"text":"Demonstrate by walking one lap yourself. Walk and pivot around a cone briskly.","text_display":"\n\nDemonstrate by walking one lap yourself. Walk and pivot around a cone briskly.","confidence":0.5849609375,"confidence_rate":0.9935604593394335},{"cnt":[[370,1904],[1846,1904],[1846,1953],[370,1953]],"region":{"top_left_x":369,"top_left_y":1903,"width":1477,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"716a675c01fc4c90846db9f868a9718b","type":"text","conversion_output":true,"text":"\"Are you ready to do that? I am going to use this counter to keep track of the number of","text_display":"\n\"Are you ready to do that? I am going to use this counter to keep track of the number of","confidence":1,"confidence_rate":1},{"cnt":[[370,1955],[1693,1955],[1693,2004],[370,2004]],"region":{"top_left_x":369,"top_left_y":1955,"width":1324,"height":50},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c0916776f4594d7fa289459dfb4ddb01","type":"text","conversion_output":true,"text":"laps you complete. I will click it each time you turn around at this starting line.","text_display":" laps you complete. I will click it each time you turn around at this starting line.","confidence":1,"confidence_rate":1},{"cnt":[[370,2007],[1876,2007],[1876,2056],[370,2056]],"region":{"top_left_x":369,"top_left_y":2006,"width":1507,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2e9796e95d74fe581a4ddf259594109","type":"text","conversion_output":true,"text":"Remember that the object is to walk AS FAR AS POSSIBLE for 6 minutes, but don't run","text_display":" Remember that the object is to walk AS FAR AS POSSIBLE for 6 minutes, but don't run","confidence":1,"confidence_rate":1},{"cnt":[[370,2058],[483,2058],[483,2108],[370,2108]],"region":{"top_left_x":369,"top_left_y":2058,"width":115,"height":50},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"904c68c6c4004429b10b0d32c2269b26","type":"text","conversion_output":true,"text":"or jog.","text_display":" or jog.","confidence":1,"confidence_rate":1},{"cnt":[[370,2131],[1023,2131],[1023,2181],[370,2181]],"region":{"top_left_x":369,"top_left_y":2131,"width":654,"height":50},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b82754d6666e41a4bc8f4b53677c27be","type":"text","conversion_output":true,"text":"Start now or whenever you are ready.\"","text_display":"\n\nStart now or whenever you are ready.\"","confidence":1,"confidence_rate":1},{"cnt":[[245,2204],[1820,2204],[1820,2254],[245,2254]],"region":{"top_left_x":244,"top_left_y":2204,"width":1576,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20e93d268b054ee396d47574b1b79a56","type":"text","conversion_output":true,"text":"8. Position the patient at the starting line. You should also stand near the starting line during","text_display":"\n8. Position the patient at the starting line. You should also stand near the starting line during","confidence":1,"confidence_rate":1},{"cnt":[[305,2258],[1811,2258],[1811,2305],[305,2305]],"region":{"top_left_x":305,"top_left_y":2258,"width":1507,"height":48},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c7aec368ca124c0799d52a49d4b93fed","type":"text","conversion_output":true,"text":"the test. Do not walk with the patient. As soon as the patient starts to walk, start the timer.","text_display":" the test. Do not walk with the patient. 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Do not get distracted and lose count of the","text_display":" phrases of encouragement. Watch the patient. Do not get distracted and lose count of the","confidence":0.9990236759185791,"confidence_rate":0.9999894968186404},{"cnt":[[305,2415],[1863,2415],[1863,2462],[305,2462]],"region":{"top_left_x":305,"top_left_y":2414,"width":1558,"height":49},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2242f2b16ad141e1ba7d5826b2e5765f","type":"text","conversion_output":true,"text":"laps. Each time the participant returns to the starting line, click the lap counter once (or mark","text_display":" laps. 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After the first minute, tell the patient the","confidence":1,"confidence_rate":1},{"cnt":[[305,357],[1858,357],[1858,410],[305,410]],"region":{"top_left_x":305,"top_left_y":356,"width":1554,"height":55},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5aad5630a31a4d8f943761f63f4ca450","type":"text","conversion_output":true,"text":"following (in even tones): \"You are doing well. You have 5 minutes to go.\" When the timer","text_display":" following (in even tones): \"You are doing well. You have 5 minutes to go.\" When the timer","confidence":1,"confidence_rate":1},{"cnt":[[305,408],[1792,408],[1792,462],[305,462]],"region":{"top_left_x":305,"top_left_y":408,"width":1487,"height":54},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20e5947700dc459fa0b7916095750b83","type":"text","conversion_output":true,"text":"shows 4 minutes remaining, tell the patient the following: \"Keep up the good work. You","text_display":" shows 4 minutes remaining, tell the patient the following: \"Keep up the good work. You","confidence":1,"confidence_rate":1},{"cnt":[[305,464],[1751,464],[1751,518],[305,518]],"region":{"top_left_x":305,"top_left_y":464,"width":1446,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"66682667a50447a7848ac951d64d35ab","type":"text","conversion_output":true,"text":"have 4 minutes to go.\" When the timer shows 3 minutes remaining, tell the patient the","text_display":" have 4 minutes to go.\" When the timer shows 3 minutes remaining, tell the patient the","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[305,516],[1828,516],[1828,569],[305,569]],"region":{"top_left_x":305,"top_left_y":515,"width":1524,"height":55},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c93a3f249854fbc98866978d8046af2","type":"text","conversion_output":true,"text":"following: \"You are doing well. You are halfway done.\" When the timer shows 2 minutes","text_display":" following: \"You are doing well. You are halfway done.\" When the timer shows 2 minutes","confidence":1,"confidence_rate":1},{"cnt":[[305,567],[1841,567],[1841,621],[305,621]],"region":{"top_left_x":305,"top_left_y":567,"width":1537,"height":54},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"10020c626a2146e49ef949e58c651786","type":"text","conversion_output":true,"text":"remaining, tell the patient the following: \"Keep up the good work. You have only2 minutes","text_display":" remaining, tell the patient the following: \"Keep up the good work. You have only2 minutes","confidence":1,"confidence_rate":1},{"cnt":[[305,619],[1846,619],[1846,672],[305,672]],"region":{"top_left_x":305,"top_left_y":618,"width":1541,"height":55},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a032495095c14e49804f3af410ee207a","type":"text","conversion_output":true,"text":"left.\" When the timer shows only 1 minute remaining, tell the patient: \"You are doing well.","text_display":" left.\" When the timer shows only 1 minute remaining, tell the patient: \"You are doing well.","confidence":1,"confidence_rate":1},{"cnt":[[305,670],[1858,670],[1858,724],[305,724]],"region":{"top_left_x":305,"top_left_y":670,"width":1554,"height":55},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae49304a964e4648887404dc6afd7d5e","type":"text","conversion_output":true,"text":"You have only 1 minute to go.\"Do not use other words of encouragement (or body language","text_display":" You have only 1 minute to go.\"Do not use other words of encouragement (or body language","confidence":0.96630859375,"confidence_rate":0.999639306743808},{"cnt":[[305,724],[531,724],[531,776],[305,776]],"region":{"top_left_x":305,"top_left_y":724,"width":226,"height":52},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6762c2e9d1874afdae69c13e0583da28","type":"text","conversion_output":true,"text":"to speed up).","text_display":" to speed up).","confidence":1,"confidence_rate":1},{"cnt":[[305,795],[1843,795],[1843,849],[305,849]],"region":{"top_left_x":305,"top_left_y":794,"width":1539,"height":55},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"07dbd5f47822433d969f0f1422feee03","type":"text","conversion_output":true,"text":"If the patient stops walking during the test and needs a rest, say this: \"You can lean against","text_display":"\n\nIf the patient stops walking during the test and needs a rest, say this: \"You can lean against","confidence":1,"confidence_rate":1},{"cnt":[[305,849],[1846,849],[1846,902],[305,902]],"region":{"top_left_x":305,"top_left_y":848,"width":1541,"height":55},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"702584612c0e47fab3f319f9e2406421","type":"text","conversion_output":true,"text":"the wall if you would like; then continue walking whenever you feel able.\" Do not stop the","text_display":" the wall if you would like; then continue walking whenever you feel able.\" Do not stop the","confidence":1,"confidence_rate":1},{"cnt":[[305,900],[1781,900],[1781,954],[305,954]],"region":{"top_left_x":305,"top_left_y":900,"width":1477,"height":54},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5181a84e970140fdaebef9bd2db16332","type":"text","conversion_output":true,"text":"timer. If the patient stops before the 6 minutes are up and refuses to continue (or you","text_display":" timer. 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When I do, just stop right where you are and I will come to you.\"","text_display":" to stop. When I do, just stop right where you are and I will come to you.\"","confidence":1,"confidence_rate":1},{"cnt":[[305,1255],[1865,1255],[1865,1308],[305,1308]],"region":{"top_left_x":305,"top_left_y":1254,"width":1560,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18ef4b61b1094eddbf7c8e962e971eb8","type":"text","conversion_output":true,"text":"When the timer rings (or buzzes), say this: \"Stop!\" Walk over to the patient. Consider taking","text_display":"\n\nWhen the timer rings (or buzzes), say this: \"Stop!\" Walk over to the patient. Consider taking","confidence":1,"confidence_rate":1},{"cnt":[[305,1306],[1878,1306],[1878,1360],[305,1360]],"region":{"top_left_x":305,"top_left_y":1306,"width":1573,"height":54},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35e2ee5740314807b2bb47da4914e9f8","type":"text","conversion_output":true,"text":"the chair if they look exhausted. Mark the spot where they stopped by placing a bean bag or a","text_display":" the chair if they look exhausted. Mark the spot where they stopped by placing a bean bag or a","confidence":0.9931671619415283,"confidence_rate":0.9999300403168763},{"cnt":[[305,1360],[746,1360],[746,1412],[305,1412]],"region":{"top_left_x":305,"top_left_y":1359,"width":441,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f236082064de42aa8add35f877eddfe2","type":"text","conversion_output":true,"text":"piece of tape on the floor.","text_display":" piece of tape on the floor.","confidence":1,"confidence_rate":1},{"cnt":[[245,1431],[1772,1431],[1772,1485],[245,1485]],"region":{"top_left_x":244,"top_left_y":1430,"width":1529,"height":55},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"94d0f0d2849e4fce9ca9c94adc1c30b3","type":"text","conversion_output":true,"text":"10. Post-test: Record the post walk Borg dyspnea and fatigue levels and ask this: \"What, if","text_display":"\n10. Post-test: Record the post walk Borg dyspnea and fatigue levels and ask this: \"What, if","confidence":1,"confidence_rate":1},{"cnt":[[305,1485],[1025,1485],[1025,1536],[305,1536]],"region":{"top_left_x":305,"top_left_y":1484,"width":720,"height":53},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8be51f277b5549d8b9fabef7cd9e598e","type":"text","conversion_output":true,"text":"anything, kept you from walking farther?\"","text_display":" anything, kept you from walking farther?\"","confidence":1,"confidence_rate":1},{"cnt":[[245,1536],[1841,1536],[1841,1588],[245,1588]],"region":{"top_left_x":244,"top_left_y":1536,"width":1598,"height":52},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c144f1867604157a97d597b7adc3f77","type":"text","conversion_output":true,"text":"11. If using a pulse oximeter, measure SpO 2 and pulse rate from the oximeter and then remove","text_display":"\n11. If using a pulse oximeter, measure SpO 2 and pulse rate from the oximeter and then remove","confidence":1,"confidence_rate":1},{"cnt":[[305,1590],[496,1590],[496,1635],[305,1635]],"region":{"top_left_x":305,"top_left_y":1589,"width":192,"height":46},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2164816e1a5842ebbba2212fe6330f93","type":"text","conversion_output":true,"text":"the sensor.","text_display":" the sensor.","confidence":1,"confidence_rate":1},{"cnt":[[247,1641],[1611,1641],[1611,1693],[247,1693]],"region":{"top_left_x":247,"top_left_y":1641,"width":1365,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2c72fa20ee24bc2b3341bed1c3afe67","type":"text","conversion_output":true,"text":"12. Record the number of laps from the counter (or tick marks on the worksheet).","text_display":"\n12. Record the number of laps from the counter (or tick marks on the worksheet).","confidence":1,"confidence_rate":1},{"cnt":[[245,1693],[1833,1693],[1833,1747],[245,1747]],"region":{"top_left_x":244,"top_left_y":1692,"width":1589,"height":55},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fd56dbf977d4054bade3c2811e369f2","type":"text","conversion_output":true,"text":"13. Record the additional distance covered (the number of meters in the final partial lap) using","text_display":"\n13. Record the additional distance covered (the number of meters in the final partial lap) using","confidence":1,"confidence_rate":1},{"cnt":[[305,1745],[1837,1745],[1837,1798],[305,1798]],"region":{"top_left_x":305,"top_left_y":1744,"width":1532,"height":55},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2314192ecc2347488e1d11ce459298ad","type":"text","conversion_output":true,"text":"the markers on the wall as distance guides. Calculate the total distance walked, rounding to","text_display":" the markers on the wall as distance guides. Calculate the total distance walked, rounding to","confidence":1,"confidence_rate":1},{"cnt":[[305,1796],[1139,1796],[1139,1848],[305,1848]],"region":{"top_left_x":305,"top_left_y":1796,"width":834,"height":52},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea4ee7fa746c4f0ea54c7cca8a6d4e9f","type":"text","conversion_output":true,"text":"the nearest meter, and record it on the worksheet.","text_display":" the nearest meter, and record it on the worksheet.","confidence":1,"confidence_rate":1},{"cnt":[[245,1848],[1416,1848],[1416,1901],[245,1901]],"region":{"top_left_x":244,"top_left_y":1847,"width":1172,"height":55},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"21106bc694de4fc59afe98a1bb79cca5","type":"text","conversion_output":true,"text":"14. 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\\multicolumn{7}{|l|}{1. In the last 2 weeks, I have been breathless climbing stairs or walling up an incline or hill.} \\\\\n\\hline 1. Every time & 2. Most times & 3. Several Times & 4. Some times & 5. Occasionally & 6. Rarely & 7. Never \\\\\n\\hline \\multicolumn{7}{|l|}{2. In the last \\(2\\) weeks, because of my lung condition, my chest has felt tight.} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{3. In the last 2 weeks have you worried about the seriousness of your lung complaint?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{4. In the last 2 weeks have you avoided doing things that make you breathless?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{5. In the last \\(2\\) weeks have you felt in control of your lung condition?} \\\\\n\\hline 1. None of the time & 2. Hardly any of the time & 3. A little of the time & 4. Some of the time & 5. A good bit of the time & 6. Most of the time & 7. All of the time \\\\\n\\hline \\multicolumn{7}{|l|}{6. In the last 2 weeks, has your lung complaint made you feel fed up or down in the dumps?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{7. In the last \\(2\\) weeks, I have felt the urge to breathe, also known as 'air hunger'.} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{8. In the last 2 weeks, my lung condition has made me feel anxious.} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{9. In the last 2 weeks, how often have you experienced 'wheeze' or whisting sounds from your chest?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{10. In the last 2 weeks, how much of the time have you felt your lung disease is getting worse?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{11. In the last 2 weeks has your lung condition interfered with your job or other daily tasks?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{12. In the last 2 weeks have you expected your lung complaint to get worse?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{13. In the last 2 weeks, how much has your lung condition limited you carrying things, for example, groceries?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{14. In the last 2 weeks, has your lung condition made you think more about the end of your life?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{15. Are you financially worse off because of your lung condition?} \\\\\n\\hline 1. A significant amount & 2. A large amount & 3. A considerable amount & 4.A reasonable amount & 5. A small amount & 6. Hardly at all & 7. Not at all \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline \\multicolumn{7}{|l|}{1. In the last 2 weeks, I have been breathless climbing stairs or walling up an incline or hill.} \\\\\n\\hline 1. Every time & 2. Most times & 3. Several Times & 4. Some times & 5. Occasionally & 6. Rarely & 7. Never \\\\\n\\hline \\multicolumn{7}{|l|}{2. In the last \\(2\\) weeks, because of my lung condition, my chest has felt tight.} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{3. In the last 2 weeks have you worried about the seriousness of your lung complaint?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{4. In the last 2 weeks have you avoided doing things that make you breathless?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{5. In the last \\(2\\) weeks have you felt in control of your lung condition?} \\\\\n\\hline 1. None of the time & 2. Hardly any of the time & 3. A little of the time & 4. Some of the time & 5. A good bit of the time & 6. Most of the time & 7. All of the time \\\\\n\\hline \\multicolumn{7}{|l|}{6. In the last 2 weeks, has your lung complaint made you feel fed up or down in the dumps?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{7. In the last \\(2\\) weeks, I have felt the urge to breathe, also known as 'air hunger'.} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{8. In the last 2 weeks, my lung condition has made me feel anxious.} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{9. In the last 2 weeks, how often have you experienced 'wheeze' or whisting sounds from your chest?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{10. In the last 2 weeks, how much of the time have you felt your lung disease is getting worse?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{11. In the last 2 weeks has your lung condition interfered with your job or other daily tasks?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{12. In the last 2 weeks have you expected your lung complaint to get worse?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{13. In the last 2 weeks, how much has your lung condition limited you carrying things, for example, groceries?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{14. In the last 2 weeks, has your lung condition made you think more about the end of your life?} \\\\\n\\hline 1. All of the time & 2. Most of the time & 3. A good bit of the time & 4. Some of the time & 5. A little of the time & 6. Hardly any of the time & 7. None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{15. Are you financially worse off because of your lung condition?} \\\\\n\\hline 1. A significant amount & 2. A large amount & 3. A considerable amount & 4.A reasonable amount & 5. A small amount & 6. Hardly at all & 7. 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Section(s) & Change \\\\\n\\hline \\begin{tabular}{l}\nSynopsis: (Study Endpoints) \\\\\nSecondary: \\\\\nPulmonary \\\\\nFunction Tests; \\\\\n2.2\n\\end{tabular} & \\begin{tabular}{l}\nRemoved PFTs: \\\\\n- Time-weighted average (TWA) of change in FVC\\% predicted from Baseline to Week 28. \\\\\n- TWA of change in FVC in ml from Baseline to Week 28. \\\\\nAdded PFTs: \\\\\n- Proportion of subjects with stable disease by FVC \\%, defined as a change in FVC \\% predicted of <5\\% from Baseline to Week 28. \\\\\n- Proportion of subjects with stable disease by absolute FVC, defined as a change in FVC of \\(<100 ml\\) from Baseline to Week 28.\n\\end{tabular} \\\\\n\\hline \\begin{tabular}{l}\nSynopsis: (Study Endpoints) \\\\\nSecondary: \\\\\nExploratory; \\\\\n2.3\n\\end{tabular} & \\begin{tabular}{l}\nAdded Other Weeks \\\\\n- Examine the change from baseline at Weeks 4, 8, 12, 16, 20, and 24 for the FVC \\% predicted, FVC (l), and 6MWT distance \\\\\nAdded Structural Imaging \\\\\n- 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the procedure for the Data Monitoring Committee. The DMC to review the safety data in a blinded manner, but a procedure will be in place to allow the committee an immediate unblinding of either specific cases or of the whole study in case of detection of a potential safety signal necessitating an unblinded review of some (or all) subjects.","text_display":"Modified the procedure for the Data Monitoring Committee. The DMC to review the safety data in a blinded manner, but a procedure will be in place to allow the committee an immediate unblinding of either specific cases or of the whole study in case of detection of a potential safety signal necessitating an unblinded review of some (or all) subjects.","cell_row":2,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.9990234375,"confidence_rate":0.9999973231826297},{"cnt":[[573,680],[1710,680],[1710,726],[573,726]],"region":{"top_left_x":573,"top_left_y":680,"width":1138,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"be9d8dfed466423f9def3ab08e86140d","type":"text","conversion_output":false,"parent_id":"147542611091411c85fe4b99bf0f03f4","text":"Modified the procedure for the Data Monitoring Committee. The DMC to","text_display":"Modified the procedure for the Data Monitoring Committee. The DMC to","confidence":0.9990234375,"confidence_rate":0.999986615984802},{"cnt":[[573,728],[1732,728],[1732,775],[573,775]],"region":{"top_left_x":573,"top_left_y":727,"width":1159,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3ac2fd388cd0461ea5d8c17bfb751813","type":"text","conversion_output":false,"parent_id":"147542611091411c85fe4b99bf0f03f4","text":"review the safety data in a blinded manner, but a procedure will be in place","text_display":" review the safety data in a blinded manner, but a procedure will be in place","confidence":1,"confidence_rate":1},{"cnt":[[573,775],[1723,775],[1723,825],[573,825]],"region":{"top_left_x":573,"top_left_y":775,"width":1151,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbec4540b3d2452db23bfada07e1ed8c","type":"text","conversion_output":false,"parent_id":"147542611091411c85fe4b99bf0f03f4","text":"to allow the committee an immediate unblinding of either specific cases or","text_display":" to allow the committee an immediate unblinding of either specific cases or","confidence":1,"confidence_rate":1},{"cnt":[[573,827],[1580,827],[1580,873],[573,873]],"region":{"top_left_x":573,"top_left_y":827,"width":1008,"height":46},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a720ff3816b64c1d9c10b52ef88812bf","type":"text","conversion_output":false,"parent_id":"147542611091411c85fe4b99bf0f03f4","text":"of the whole study in case of detection of a potential safety signal","text_display":" of the whole study in case of detection of a potential safety signal","confidence":1,"confidence_rate":1},{"cnt":[[573,875],[1487,875],[1487,920],[573,920]],"region":{"top_left_x":573,"top_left_y":874,"width":914,"height":47},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1e1ea67f0d334de1bf804323258c27cb","type":"text","conversion_output":false,"parent_id":"147542611091411c85fe4b99bf0f03f4","text":"necessitating an unblinded review of some (or all) subjects.","text_display":" necessitating an unblinded review of some (or all) subjects.","confidence":1,"confidence_rate":1},{"cnt":[[261,949],[480,949],[480,1046],[261,1046]],"region":{"top_left_x":261,"top_left_y":948,"width":220,"height":99},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95afbca94dd04a26872f4760a67d5b2c","type":"complex_cell","conversion_output":false,"parent_id":"dd0fe85bd2e74ae5b46207c06e6fdea7","children_ids":["42033fd792234432b373e3c4182e72f7","8417e11b473343669f4c82d4390e6596"],"text":"6.2; 7.12.1.2; Appendix A","text_display":"6.2; 7.12.1.2; Appendix A","cell_row":3,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[266,953],[476,953],[476,994],[266,994]],"region":{"top_left_x":265,"top_left_y":952,"width":211,"height":43},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42033fd792234432b373e3c4182e72f7","type":"text","conversion_output":false,"parent_id":"95afbca94dd04a26872f4760a67d5b2c","text":"6.2; 7.12.1.2;","text_display":"6.2; 7.12.1.2;","confidence":1,"confidence_rate":1},{"cnt":[[266,996],[463,996],[463,1042],[266,1042]],"region":{"top_left_x":265,"top_left_y":996,"width":198,"height":46},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8417e11b473343669f4c82d4390e6596","type":"text","conversion_output":false,"parent_id":"95afbca94dd04a26872f4760a67d5b2c","text":"Appendix A","text_display":" Appendix A","confidence":1,"confidence_rate":1},{"cnt":[[569,962],[1725,962],[1725,1115],[569,1115]],"region":{"top_left_x":568,"top_left_y":961,"width":1158,"height":155},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e07c95d9cc5046ea8af3a41812a8ecf5","type":"complex_cell","conversion_output":false,"parent_id":"dd0fe85bd2e74ae5b46207c06e6fdea7","children_ids":["ab3a2c3fe6a54299b5b77a681cca0e49","9385ec1733204443bb3a667e0050d893","e194ff314e0e4197a394403cba9f8069"],"text":"Clarified that if a subject experiences an infusion related reaction, an ECG and a blood sample for cytokines should be collected as soon as possible after stabilization of the subject.","text_display":"Clarified that if a subject experiences an infusion related reaction, an ECG and a blood sample for cytokines should be collected as soon as possible after stabilization of the subject.","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[573,966],[1719,966],[1719,1011],[573,1011]],"region":{"top_left_x":573,"top_left_y":965,"width":1146,"height":47},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ab3a2c3fe6a54299b5b77a681cca0e49","type":"text","conversion_output":false,"parent_id":"e07c95d9cc5046ea8af3a41812a8ecf5","text":"Clarified that if a subject experiences an infusion related reaction, an ECG","text_display":"Clarified that if a subject experiences an infusion related reaction, an ECG","confidence":1,"confidence_rate":1},{"cnt":[[573,1014],[1693,1014],[1693,1063],[573,1063]],"region":{"top_left_x":573,"top_left_y":1013,"width":1120,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9385ec1733204443bb3a667e0050d893","type":"text","conversion_output":false,"parent_id":"e07c95d9cc5046ea8af3a41812a8ecf5","text":"and a blood sample for cytokines should be collected as soon as possible","text_display":" and a blood sample for cytokines should be collected as soon as possible","confidence":1,"confidence_rate":1},{"cnt":[[573,1066],[1071,1066],[1071,1111],[573,1111]],"region":{"top_left_x":573,"top_left_y":1065,"width":499,"height":47},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e194ff314e0e4197a394403cba9f8069","type":"text","conversion_output":false,"parent_id":"e07c95d9cc5046ea8af3a41812a8ecf5","text":"after stabilization of the subject.","text_display":" after stabilization of the 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In the last 2 weeks, have you been tired because of your cough?","confidence":1,"confidence_rate":1},{"cnt":[[327,694],[1115,694],[1115,758],[327,758]],"region":{"top_left_x":326,"top_left_y":693,"width":790,"height":66},"line":27,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"fd81f704742643cea6ef67027f8310c9","type":"multiple_choice_block","conversion_output":false,"children_ids":["43a201e84a914500950b8573a952af71","01a17abaabfe4e3387727c0d01796348","9b36d3c4670d42e8b1f97bbffc83e085","34b2ef7026f9432c9da756b06f3713f3"],"text":"","text_display":""},{"cnt":[[329,692],[350,692],[350,722],[329,722]],"region":{"top_left_x":328,"top_left_y":691,"width":23,"height":31},"line":28,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"43a201e84a914500950b8573a952af71","type":"text","conversion_output":true,"parent_id":"fd81f704742643cea6ef67027f8310c9","text":"1","text_display":"\n1","confidence":1,"confidence_rate":1},{"cnt":[[552,700],[569,700],[569,722],[552,722]],"region":{"top_left_x":552,"top_left_y":700,"width":18,"height":22},"line":29,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"01a17abaabfe4e3387727c0d01796348","type":"text","conversion_output":true,"parent_id":"fd81f704742643cea6ef67027f8310c9","text":"2","text_display":"\n2","confidence":1,"confidence_rate":1},{"cnt":[[765,696],[995,696],[995,720],[765,720]],"region":{"top_left_x":764,"top_left_y":696,"width":231,"height":24},"line":30,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"9b36d3c4670d42e8b1f97bbffc83e085","type":"text","conversion_output":true,"parent_id":"fd81f704742643cea6ef67027f8310c9","text":"34","text_display":"\n34","confidence":1,"confidence_rate":1},{"cnt":[[980,718],[1124,718],[1124,746],[980,746]],"region":{"top_left_x":979,"top_left_y":717,"width":145,"height":29},"line":31,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"34b2ef7026f9432c9da756b06f3713f3","type":"text","conversion_output":true,"parent_id":"fd81f704742643cea6ef67027f8310c9","text":"Some of the time","text_display":"\nSome of the time","confidence":1,"confidence_rate":1},{"cnt":[[1190,696],[1347,696],[1347,748],[1190,748]],"region":{"top_left_x":1190,"top_left_y":696,"width":158,"height":52},"line":32,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"30a182dd6e9341298ee8419032258dc7","type":"multiple_choice_option","conversion_output":false,"children_ids":["dde7dc8377724daab7bf32a73cd70acf","d532a542af26424db16b9edde8207b1a"],"text":"","text_display":""},{"cnt":[[1195,692],[1216,692],[1216,722],[1195,722]],"region":{"top_left_x":1194,"top_left_y":691,"width":23,"height":31},"line":33,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"dde7dc8377724daab7bf32a73cd70acf","type":"text","conversion_output":true,"parent_id":"30a182dd6e9341298ee8419032258dc7","text":"5","text_display":"\n5","confidence":1,"confidence_rate":1},{"cnt":[[1195,722],[1343,722],[1343,746],[1195,746]],"region":{"top_left_x":1194,"top_left_y":721,"width":149,"height":25},"line":34,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"d532a542af26424db16b9edde8207b1a","type":"text","conversion_output":true,"parent_id":"30a182dd6e9341298ee8419032258dc7","text":"A little of the time","text_display":"\nA little of the time","confidence":1,"confidence_rate":1},{"cnt":[[303,761],[982,761],[982,793],[303,793]],"region":{"top_left_x":302,"top_left_y":760,"width":680,"height":33},"line":35,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"6e476c1e1815499e9ef9d78a9050b471","type":"text","conversion_output":true,"text":"4. In the last 2 weeks, have you felt in control of your cough?","text_display":"\n4. In the last 2 weeks, have you felt in control of your cough?","confidence":1,"confidence_rate":1},{"cnt":[[327,795],[1128,795],[1128,862],[327,862]],"region":{"top_left_x":326,"top_left_y":794,"width":802,"height":68},"line":36,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"a33815b545e24f668256e13470301820","type":"table","conversion_output":true,"text":"\\begin{tabular}{llll}\n1 & 2 & 3 & 4 \\\\\nNone of the time & Hardly any of the time & A little of the time & Some of the time\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{llll}\n1 & 2 & 3 & 4 \\\\\nNone of the time & Hardly any of the time & A little of the time & Some of the time\n\\end{tabular}","confidence":0.99951171875,"confidence_rate":0.9999962139567942},{"cnt":[[1192,795],[1766,795],[1766,849],[1192,849]],"region":{"top_left_x":1192,"top_left_y":794,"width":575,"height":55},"line":37,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"3d17cd0dc50e4f0494f0e86aded7e6f0","type":"table","conversion_output":true,"text":"\\begin{tabular}{lll}\n5 & 6 & 7 \\\\\nA good bit of the time & Most of the time & All of the time\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{lll}\n5 & 6 & 7 \\\\\nA good bit of the time & Most of the time & All of the time\n\\end{tabular}","confidence":1,"confidence_rate":1},{"cnt":[[303,862],[1222,862],[1222,896],[303,896]],"region":{"top_left_x":302,"top_left_y":861,"width":921,"height":35},"line":38,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ca8b92dcff294c7f80928887d18de0c7","type":"text","conversion_output":true,"text":"5. How often during the last 2 weeks have you felt embarrassed by your coughing?","text_display":"\n5. How often during the last 2 weeks have you felt embarrassed by your coughing?","confidence":1,"confidence_rate":1},{"cnt":[[327,894],[1772,894],[1772,952],[327,952]],"region":{"top_left_x":326,"top_left_y":893,"width":1447,"height":59},"line":39,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"165d384382814932aed7f69d5e904d72","type":"table","conversion_output":true,"text":"\\begin{tabular}{lllllll}\n1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\nAll of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{lllllll}\n1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\nAll of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time\n\\end{tabular}","confidence":0.9383796411526646,"confidence_rate":0.9997122555369035},{"cnt":[[305,962],[965,962],[965,995],[305,995]],"region":{"top_left_x":305,"top_left_y":962,"width":660,"height":33},"line":40,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8265c6f6108a430792b31e927c602e12","type":"text","conversion_output":true,"text":"6. In the last 2 weeks, my cough has made me feel anxious","text_display":"\n6. In the last 2 weeks, my cough has made me feel anxious","confidence":1,"confidence_rate":1},{"cnt":[[327,997],[1768,997],[1768,1055],[327,1055]],"region":{"top_left_x":326,"top_left_y":996,"width":1443,"height":59},"line":41,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"f6d5ffef3f3e45f78a418b88fad85c02","type":"table","conversion_output":true,"text":"\\begin{tabular}{lllllll}\n1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\nAll of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{lllllll}\n1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\nAll of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time\n\\end{tabular}","confidence":0.7611022801937382,"confidence_rate":0.9987655249097112},{"cnt":[[301,1066],[1182,1066],[1182,1098],[301,1098]],"region":{"top_left_x":300,"top_left_y":1065,"width":882,"height":33},"line":42,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ea6e55027f244288825d0c222afc0785","type":"text","conversion_output":true,"text":"7. In the last 2 weeks, my cough has interfered with my job, or other daily tasks","text_display":"\n7. In the last 2 weeks, my cough has interfered with my job, or other daily tasks","confidence":1,"confidence_rate":1},{"cnt":[[327,1100],[1772,1100],[1772,1156],[327,1156]],"region":{"top_left_x":326,"top_left_y":1100,"width":1447,"height":56},"line":43,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"5fa87c63b2bc4ab4903443db413c6852","type":"table","conversion_output":true,"text":"\\begin{tabular}{lllllll}\n1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\nAll of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{lllllll}\n1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\nAll of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time\n\\end{tabular}","confidence":0.9476908849584932,"confidence_rate":0.9997569214007956},{"cnt":[[301,1164],[1287,1164],[1287,1197],[301,1197]],"region":{"top_left_x":300,"top_left_y":1164,"width":987,"height":33},"line":44,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"8b41fbcd8c444d08b966022eae1b2e8d","type":"text","conversion_output":true,"text":"8. In the last 2 weeks, I felt that my cough interfered with the overall enjoyment of my life","text_display":"\n8. 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In the last 2 weeks, has your cough disturbed your sleep?} \\\\\n\\hline 1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\n\\hline All of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|l|l|l|l|}\n\\hline 1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\n\\hline All of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{In the last 2 weeks, exposure to paints or fumes has made me cough} \\\\\n\\hline 1 & 2 & 3 & 4 & 5 & 6 & 7 \\\\\n\\hline All of the time & Most of the time & A good bit of the time & Some of the time & A little of the time & Hardly any of the time & None of the time \\\\\n\\hline \\multicolumn{7}{|l|}{0. 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