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to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) \\\\\n\\hline Indication & Heart failure with preserved ejection fraction \\\\\n\\hline Location & Approximately 20 clinical centers in the United States \\\\\n\\hline Brief Rationale & \\begin{tabular}{l}\nApproximately half of Americans with heart failure (HF) have preserved ejection fraction (HFpEF). There is no proven treatment that improves outcome. The pathophysiology is complex and includes left ventricular (LV) systolic and diastolic dysfunction, pulmonary vascular disease, endothelial dysfunction, and peripheral abnormalities. Multiple lines of evidence point to impaired NO-cGMP bioavailability as playing a central role in each of these abnormalities. \\\\\nNO-cGMP levels can be increased using direct NO donors, such as the organic nitrates. The HFN NEAT trial tested whether treatment with organic nitrates (isosorbide mononitrate, ISMN) for 4 weeks could improve daily activity levels as assessed by accelerometry. \\\\\nHowever, organic nitrates have several shortcomings, including the development of tolerance, greater vulnerability to hypotension in patients with HFpEF, development of 'pseudo-tolerance', where chronic venodilation leads to renal sodium retention, and increases in oxidative stress and endothelial dysfunction. \\\\\nAn alternative strategy to restore Nitric oxide-cyclic guanosine monophosphate (NO-cGMP) signaling is via inorganic nitrite (NO2). While previously considered to be an inert byproduct of NO metabolism, NO2 has been shown to be an important in vivo reservoir for NO generation. Notably, reduction of \\(NO _{2}\\) to NO is enhanced under hypoxic and acidemic conditions, meaning that the molecule becomes most active at the time of greatest need (e.g., during exercise). \\\\\nAncillary analyses from the CHAMPION trial have revealed that reduction in pulmonary artery (PA) and PA wedge pressure are associated with marked reduction in HF hospitalizations in HFpEF, emphasizing the importance of filling pressure reduction to improve morbidity in HFpEF. To this end, recent studies have shown that acute \\(NO _{2}\\) infusion markedly blunts the increase in PA and PA wedge pressure during exercise in HFpEF, while improving cardiac output reserve. A similar noninvasive study using inorganic nitrate \\(\\left( NO _{3}\\right)\\) (naturally occurring in beetroot juice) similarly improved aerobic capacity and enhanced cardiac output reserve and systemic vasodilation in HFpEF. \\\\\nAccordingly, INDIE-HFpEF will test the effects of longer term \\(NO _{2}\\) therapy on exercise capacity and chronic daily activity levels in HFpEF.\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|}\n\\hline Title & Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF (INDIE-HFpEF) \\\\\n\\hline Indication & Heart failure with preserved ejection fraction \\\\\n\\hline Location & Approximately 20 clinical centers in the United States \\\\\n\\hline Brief Rationale & \\begin{tabular}{l}\nApproximately half of Americans with heart failure (HF) have preserved ejection fraction (HFpEF). There is no proven treatment that improves outcome. The pathophysiology is complex and includes left ventricular (LV) systolic and diastolic dysfunction, pulmonary vascular disease, endothelial dysfunction, and peripheral abnormalities. Multiple lines of evidence point to impaired NO-cGMP bioavailability as playing a central role in each of these abnormalities. \\\\\nNO-cGMP levels can be increased using direct NO donors, such as the organic nitrates. 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A similar noninvasive study using inorganic nitrate \\(\\left( NO _{3}\\right)\\) (naturally occurring in beetroot juice) similarly improved aerobic capacity and enhanced cardiac output reserve and systemic vasodilation in HFpEF. \\\\\nAccordingly, INDIE-HFpEF will test the effects of longer term \\(NO _{2}\\) therapy on exercise capacity and chronic daily activity levels in HFpEF.\n\\end{tabular} 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half of Americans with heart failure (HF) have preserved ejection fraction (HFpEF). There is no proven treatment that improves outcome. The pathophysiology is complex and includes left ventricular (LV) systolic and diastolic dysfunction, pulmonary vascular disease, endothelial dysfunction, and peripheral abnormalities. Multiple lines of evidence point to impaired NO-cGMP bioavailability as playing a central role in each of these abnormalities. \\\\\nNO-cGMP levels can be increased using direct NO donors, such as the organic nitrates. The HFN NEAT trial tested whether treatment with organic nitrates (isosorbide mononitrate, ISMN) for 4 weeks could improve daily activity levels as assessed by accelerometry. \\\\\nHowever, organic nitrates have several shortcomings, including the development of tolerance, greater vulnerability to hypotension in patients with HFpEF, development of 'pseudo-tolerance', where chronic venodilation leads to renal sodium retention, and increases in oxidative stress and endothelial dysfunction. \\\\\nAn alternative strategy to restore Nitric oxide-cyclic guanosine monophosphate (NO-cGMP) signaling is via inorganic nitrite (NO2). While previously considered to be an inert byproduct of NO metabolism, NO2 has been shown to be an important in vivo reservoir for NO generation. Notably, reduction of \\(NO _{2}\\) to NO is enhanced under hypoxic and acidemic conditions, meaning that the molecule becomes most active at the time of greatest need (e.g., during exercise). \\\\\nAncillary analyses from the CHAMPION trial have revealed that reduction in pulmonary artery (PA) and PA wedge pressure are associated with marked reduction in HF hospitalizations in HFpEF, emphasizing the importance of filling pressure reduction to improve morbidity in HFpEF. To this end, recent studies have shown that acute \\(NO _{2}\\) infusion markedly blunts the increase in PA and PA wedge pressure during exercise in HFpEF, while improving cardiac output reserve. A similar noninvasive study using inorganic nitrate \\(\\left( NO _{3}\\right)\\) (naturally occurring in beetroot juice) similarly improved aerobic capacity and enhanced cardiac output reserve and systemic vasodilation in HFpEF. \\\\\nAccordingly, INDIE-HFpEF will test the effects of longer term \\(NO _{2}\\) therapy on exercise capacity and chronic daily activity levels in HFpEF.\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nApproximately half of Americans with heart failure (HF) have preserved ejection fraction (HFpEF). There is no proven treatment that improves outcome. The pathophysiology is complex and includes left ventricular (LV) systolic and diastolic dysfunction, pulmonary vascular disease, endothelial dysfunction, and peripheral abnormalities. Multiple lines of evidence point to impaired NO-cGMP bioavailability as playing a central role in each of these abnormalities. \\\\\nNO-cGMP levels can be increased using direct NO donors, such as the organic nitrates. The HFN NEAT trial tested whether treatment with organic nitrates (isosorbide mononitrate, ISMN) for 4 weeks could improve daily activity levels as assessed by accelerometry. \\\\\nHowever, organic nitrates have several shortcomings, including the development of tolerance, greater vulnerability to hypotension in patients with HFpEF, development of 'pseudo-tolerance', where chronic venodilation leads to renal sodium retention, and increases in oxidative stress and endothelial dysfunction. \\\\\nAn alternative strategy to restore Nitric oxide-cyclic guanosine monophosphate (NO-cGMP) signaling is via inorganic nitrite (NO2). While previously considered to be an inert byproduct of NO metabolism, NO2 has been shown to be an important in vivo reservoir for NO generation. Notably, reduction of \\(NO _{2}\\) to NO is enhanced under hypoxic and acidemic conditions, meaning that the molecule becomes most active at the time of greatest need (e.g., during exercise). \\\\\nAncillary analyses from the CHAMPION trial have revealed that reduction in pulmonary artery (PA) and PA wedge pressure are associated with marked reduction in HF hospitalizations in HFpEF, emphasizing the importance of filling pressure reduction to improve morbidity in HFpEF. To this end, recent studies have shown that acute \\(NO _{2}\\) infusion markedly blunts the increase in PA and PA wedge pressure during exercise in HFpEF, while improving cardiac output reserve. A similar noninvasive study using inorganic nitrate \\(\\left( NO _{3}\\right)\\) (naturally occurring in beetroot juice) similarly improved aerobic capacity and enhanced cardiac output reserve and systemic vasodilation in HFpEF. \\\\\nAccordingly, INDIE-HFpEF will test the effects of longer term \\(NO _{2}\\) therapy on exercise capacity and chronic daily activity levels in HFpEF.\n\\end{tabular}","cell_row":3,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":0.5843898260500282,"confidence_rate":0.9994209585806338},{"cnt":[[647,591],[1853,591],[1853,636],[647,636]],"region":{"top_left_x":647,"top_left_y":590,"width":1207,"height":47},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"077748a6785e4a19b1dc66e99fc58aaf","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"Approximately half of Americans with heart failure (HF) have preserved","text_display":"Approximately half of Americans with heart failure (HF) have preserved","confidence":0.6857001781463623,"confidence_rate":0.994981769536569},{"cnt":[[649,638],[1843,638],[1843,688],[649,688]],"region":{"top_left_x":649,"top_left_y":638,"width":1194,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d522b2b6f1644ef1b2f9cce6d5b5653e","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"ejection fraction (HFpEF). There is no proven treatment that improves","text_display":" ejection fraction (HFpEF). There is no proven treatment that improves","confidence":1,"confidence_rate":1},{"cnt":[[647,690],[1851,690],[1851,736],[647,736]],"region":{"top_left_x":647,"top_left_y":690,"width":1205,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a56b6fe270a445ecacdf034c1416ef1b","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"outcome. The pathophysiology is complex and includes left ventricular","text_display":" outcome. The pathophysiology is complex and includes left ventricular","confidence":1,"confidence_rate":1},{"cnt":[[649,740],[1793,740],[1793,788],[649,788]],"region":{"top_left_x":649,"top_left_y":739,"width":1144,"height":49},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5a99f3c741e4192bd51f4349a07aad2","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"(LV) systolic and diastolic dysfunction, pulmonary vascular disease,","text_display":" (LV) systolic and diastolic dysfunction, pulmonary vascular disease,","confidence":1,"confidence_rate":1},{"cnt":[[649,790],[1847,790],[1847,840],[649,840]],"region":{"top_left_x":649,"top_left_y":789,"width":1198,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"42f337d46b904e26b446c8c47046208f","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"endothelial dysfunction, and peripheral abnormalities. Multiple lines of","text_display":" endothelial dysfunction, and peripheral abnormalities. Multiple lines of","confidence":1,"confidence_rate":1},{"cnt":[[649,842],[1864,842],[1864,892],[649,892]],"region":{"top_left_x":649,"top_left_y":841,"width":1216,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8478afeb47724e51a31ea556b944ca32","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"evidence point to impaired NO-cGMP bioavailability as playing a central","text_display":" evidence point to impaired NO-cGMP bioavailability as playing a central","confidence":1,"confidence_rate":1},{"cnt":[[649,894],[1245,894],[1245,935],[649,935]],"region":{"top_left_x":649,"top_left_y":893,"width":596,"height":42},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba0d7143630947c68d8f28cafa58c50d","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"role in each of these abnormalities.","text_display":" role in each of these abnormalities.","confidence":1,"confidence_rate":1},{"cnt":[[647,972],[1860,972],[1860,1017],[647,1017]],"region":{"top_left_x":647,"top_left_y":971,"width":1213,"height":47},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"71c4d3e992754db7be28b146c2b5c4bb","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"NO-cGMP levels can be increased using direct NO donors, such as the","text_display":"\nNO-cGMP levels can be increased using direct NO donors, such as the","confidence":1,"confidence_rate":1},{"cnt":[[649,1019],[1799,1019],[1799,1069],[649,1069]],"region":{"top_left_x":649,"top_left_y":1019,"width":1151,"height":51},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8460d00351c343838176fb710d706a58","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"organic nitrates. The HFN NEAT trial tested whether treatment with","text_display":" organic nitrates. The HFN NEAT trial tested whether treatment with","confidence":1,"confidence_rate":1},{"cnt":[[649,1071],[1765,1071],[1765,1119],[649,1119]],"region":{"top_left_x":649,"top_left_y":1071,"width":1116,"height":48},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7e3c504f59740c3a1b4e733b9c4db81","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"organic nitrates (isosorbide mononitrate, ISMN) for 4 weeks could","text_display":" organic nitrates (isosorbide mononitrate, ISMN) for 4 weeks could","confidence":1,"confidence_rate":1},{"cnt":[[647,1123],[1648,1123],[1648,1169],[647,1169]],"region":{"top_left_x":647,"top_left_y":1123,"width":1001,"height":46},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abf4f3e6c0e046d7a0e53db9f96692b6","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"improve daily activity levels as assessed by accelerometry.","text_display":" improve daily activity levels as assessed by accelerometry.","confidence":1,"confidence_rate":1},{"cnt":[[649,1201],[1791,1201],[1791,1247],[649,1247]],"region":{"top_left_x":649,"top_left_y":1201,"width":1142,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"72c2a435335b417f82cf3d0579fd2e49","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"However, organic nitrates have several shortcomings, including the","text_display":"\nHowever, organic nitrates have several shortcomings, including the","confidence":1,"confidence_rate":1},{"cnt":[[649,1251],[1882,1251],[1882,1299],[649,1299]],"region":{"top_left_x":649,"top_left_y":1251,"width":1233,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4c2428ef7da44d7a5899896acb86f03","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"development of tolerance, greater vulnerability to hypotension in patients","text_display":" development of tolerance, greater vulnerability to hypotension in patients","confidence":1,"confidence_rate":1},{"cnt":[[647,1301],[1721,1301],[1721,1346],[647,1346]],"region":{"top_left_x":647,"top_left_y":1300,"width":1075,"height":47},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d12a082ed03940d796712b49f3374d38","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"with HFpEF, development of 'pseudo-tolerance', where chronic","text_display":" with HFpEF, development of 'pseudo-tolerance', where chronic","confidence":1,"confidence_rate":1},{"cnt":[[647,1348],[1853,1348],[1853,1396],[647,1396]],"region":{"top_left_x":647,"top_left_y":1348,"width":1207,"height":49},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"772f9a860b364daf870b626ef347e173","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"venodilation leads to renal sodium retention, and increases in oxidative","text_display":" venodilation leads to renal sodium retention, and increases in oxidative","confidence":1,"confidence_rate":1},{"cnt":[[649,1400],[1241,1400],[1241,1450],[649,1450]],"region":{"top_left_x":649,"top_left_y":1400,"width":592,"height":51},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"842c90a966e144e08508cf0b0bd2a844","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"stress and endothelial dysfunction.","text_display":" stress and endothelial dysfunction.","confidence":1,"confidence_rate":1},{"cnt":[[647,1478],[1700,1478],[1700,1528],[647,1528]],"region":{"top_left_x":647,"top_left_y":1478,"width":1053,"height":51},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"379da8318d694bd4a8c5016508ec5c96","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"An alternative strategy to restore Nitric oxide-cyclic guanosine","text_display":"\nAn alternative strategy to restore Nitric oxide-cyclic guanosine","confidence":1,"confidence_rate":1},{"cnt":[[647,1530],[1890,1530],[1890,1580],[647,1580]],"region":{"top_left_x":647,"top_left_y":1530,"width":1244,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4fb5081df2074c4a9f006130e9d72083","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"monophosphate (NO-cGMP) signaling is via inorganic nitrite (NO2). While","text_display":" monophosphate (NO-cGMP) signaling is via inorganic nitrite (NO2). While","confidence":0.9926962580234961,"confidence_rate":0.9999035501135977},{"cnt":[[649,1582],[1847,1582],[1847,1628],[649,1628]],"region":{"top_left_x":649,"top_left_y":1582,"width":1198,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bcd708169f17421180246597a5f13736","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"previously considered to be an inert byproduct of NO metabolism, NO2","text_display":" previously considered to be an inert byproduct of NO metabolism, NO2","confidence":0.6429555416107178,"confidence_rate":0.9939678600130241},{"cnt":[[647,1630],[1851,1630],[1851,1678],[647,1678]],"region":{"top_left_x":647,"top_left_y":1629,"width":1205,"height":49},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d68a17cdc8c14f648d962f255955a964","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"has been shown to be an important in vivo reservoir for NO generation.","text_display":" has been shown to be an important in vivo reservoir for NO generation.","confidence":0.9951210021972656,"confidence_rate":0.9999347896067039},{"cnt":[[647,1682],[1739,1682],[1739,1730],[647,1730]],"region":{"top_left_x":647,"top_left_y":1681,"width":1092,"height":49},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a804732bb94e4aa1b856a9426b85899c","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"Notably, reduction of \\(NO _{2}\\) to NO is enhanced under hypoxic and","text_display":" Notably, reduction of \\(NO _{2}\\) to NO is enhanced under hypoxic and","confidence":0.994140625,"confidence_rate":0.9999308658194189},{"cnt":[[647,1730],[1871,1730],[1871,1779],[647,1779]],"region":{"top_left_x":647,"top_left_y":1729,"width":1224,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b7c3451158d4bc4a439ad1f4ffe0876","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"acidemic conditions, meaning that the molecule becomes most active at","text_display":" acidemic conditions, meaning that the molecule becomes most active at","confidence":1,"confidence_rate":1},{"cnt":[[647,1782],[1468,1782],[1468,1831],[647,1831]],"region":{"top_left_x":647,"top_left_y":1781,"width":822,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2144ec4ef3334ab9a9371206cfa24db8","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"the time of greatest need (e.g., during exercise).","text_display":" the time of greatest need (e.g., during exercise).","confidence":1,"confidence_rate":1},{"cnt":[[647,1860],[1895,1860],[1895,1909],[647,1909]],"region":{"top_left_x":647,"top_left_y":1859,"width":1248,"height":51},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f1066cea0404d8f892cb916ed6ad2c2","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"Ancillary analyses from the CHAMPION trial have revealed that reduction","text_display":"\nAncillary analyses from the CHAMPION trial have revealed that reduction","confidence":1,"confidence_rate":1},{"cnt":[[647,1911],[1825,1911],[1825,1961],[647,1961]],"region":{"top_left_x":647,"top_left_y":1911,"width":1179,"height":51},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2eb513bb798e492b873a5f71e7268047","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"in pulmonary artery (PA) and PA wedge pressure are associated with","text_display":" in pulmonary artery (PA) and PA wedge pressure are associated with","confidence":1,"confidence_rate":1},{"cnt":[[647,1961],[1795,1961],[1795,2009],[647,2009]],"region":{"top_left_x":647,"top_left_y":1961,"width":1149,"height":48},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"edac18e28a0845aa8c1ba0d6df426e94","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"marked reduction in HF hospitalizations in HFpEF, emphasizing the","text_display":" marked reduction in HF hospitalizations in HFpEF, emphasizing the","confidence":1,"confidence_rate":1},{"cnt":[[647,2011],[1847,2011],[1847,2061],[647,2061]],"region":{"top_left_x":647,"top_left_y":2011,"width":1200,"height":50},"line":46,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3b96092d5b442e9a9a1fe2c7f74667a","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"importance of filling pressure reduction to improve morbidity in HFpEF.","text_display":" importance of filling pressure reduction to improve morbidity in HFpEF.","confidence":0.9990234375,"confidence_rate":0.9999871442977954},{"cnt":[[649,2063],[1888,2063],[1888,2111],[649,2111]],"region":{"top_left_x":649,"top_left_y":2063,"width":1240,"height":48},"line":47,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c18418fd339840d3b69888ec2bbe9255","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"To this end, recent studies have shown that acute \\(NO _{2}\\) infusion markedly","text_display":" To this end, recent studies have shown that acute \\(NO _{2}\\) infusion markedly","confidence":0.99951171875,"confidence_rate":0.9999945123690109},{"cnt":[[647,2111],[1808,2111],[1808,2161],[647,2161]],"region":{"top_left_x":647,"top_left_y":2110,"width":1161,"height":51},"line":48,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"629a4f865a3b45edb9fb9a24d5d0610e","type":"text","conversion_output":false,"parent_id":"e7e7b274d61f424b9524d9e41b510b4f","text":"blunts the increase in PA and PA wedge pressure during exercise in","text_display":" blunts the increase in PA and PA wedge pressure during exercise 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Approximately 100 participants will be enrolled in this 2*2 crossover study. \\\\\n\\hline Treatment & Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day. \\\\\n\\hline Primary Objective and Endpoint & The primary endpoint will be the peak \\(VO _{2}\\) after 4 weeks treatment with inorganic nitrite as compared to the peak \\(VO _{2}\\) after 4 weeks treatment with placebo as assessed by cardiopulmonary exercise testing (CPET) performed at peak drug levels. \\\\\n\\hline Secondary Objectives and Endpoints & \\begin{tabular}{l}\n1. To evaluate whether inorganic nitrite improves submaximal activity tolerance chronically. \\\\\n- Average arbitrary accelerometer units (AAU) during at least 14 days and up to 21 days of the maximally tolerated dose of study drug (from 28 days post Study Visit 1 until Study Visit 2 and from 28 days post Study Visit 2 until Study Visit 3). \\\\\n2. To evaluate whether inorganic nitrite improves quality of life. \\\\\n- Quality of Life (Kansas City Cardiomyopathy Questionnaire score, KCCQ) \\\\\n- NYHA class \\\\\n- Participant preference for study phase (active vs. placebo) \\\\\n3. To evaluate whether inorganic nitrite improves chronic filling pressures as assessed by echocardiography and natriuretic peptide levels. \\\\\n- E/e' ratio on echocardiography \\\\\n- Left atrial volume index on echocardiography \\\\\n- Pulmonary artery systolic pressure on echocardiography \\\\\n- N-terminal pro-B-type natriuretic peptide level \\\\\n4. 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To evaluate whether inorganic nitrite improves submaximal activity tolerance chronically. \\\\\n- Average arbitrary accelerometer units (AAU) during at least 14 days and up to 21 days of the maximally tolerated dose of study drug (from 28 days post Study Visit 1 until Study Visit 2 and from 28 days post Study Visit 2 until Study Visit 3). \\\\\n2. To evaluate whether inorganic nitrite improves quality of life. \\\\\n- Quality of Life (Kansas City Cardiomyopathy Questionnaire score, KCCQ) \\\\\n- NYHA class \\\\\n- Participant preference for study phase (active vs. placebo) \\\\\n3. To evaluate whether inorganic nitrite improves chronic filling pressures as assessed by echocardiography and natriuretic peptide levels. \\\\\n- E/e' ratio on echocardiography \\\\\n- Left atrial volume index on echocardiography \\\\\n- Pulmonary artery systolic pressure on echocardiography \\\\\n- N-terminal pro-B-type natriuretic peptide level \\\\\n4. To evaluate whether inorganic nitrite improves ventilatory efficiency or submaximal exercise capacity at peak drug levels. \\\\\n- \\(V _{ E } / VCO _{2}\\) slope \\\\\n- \\(\\quad VO _{2}\\) at ventilatory threshold \\\\\n5. To evaluate safety and tolerability of inhaled, nebulized sodium inorganic nitrite. \\\\\n- Headache \\\\\n- Lightheadedness/orthostasis \\\\\n- Other AEs\n\\end{tabular}","text_display":"\\begin{tabular}{l}\n1. To evaluate whether inorganic nitrite improves submaximal activity tolerance chronically. \\\\\n- Average arbitrary accelerometer units (AAU) during at least 14 days and up to 21 days of the maximally tolerated dose of study drug (from 28 days post Study Visit 1 until Study Visit 2 and from 28 days post Study Visit 2 until Study Visit 3). \\\\\n2. To evaluate whether inorganic nitrite improves quality of life. \\\\\n- Quality of Life (Kansas City Cardiomyopathy Questionnaire score, KCCQ) \\\\\n- NYHA class \\\\\n- Participant preference for study phase (active vs. placebo) \\\\\n3. To evaluate whether inorganic nitrite improves chronic filling pressures as assessed by echocardiography and natriuretic peptide levels. \\\\\n- E/e' ratio on echocardiography \\\\\n- Left atrial volume index on echocardiography \\\\\n- Pulmonary artery systolic pressure on echocardiography \\\\\n- N-terminal pro-B-type natriuretic peptide level \\\\\n4. To evaluate whether inorganic nitrite improves ventilatory efficiency or submaximal exercise capacity at peak drug levels. \\\\\n- \\(V _{ E } / VCO _{2}\\) slope \\\\\n- \\(\\quad VO _{2}\\) at ventilatory threshold \\\\\n5. 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participate). \\\\\n- Obtain limited echocardiogram**. \\\\\n- Perform CPET with Study Drug administered immediately before starting the CPET (primary endpoint). \\\\\n- Return accelerometer and phase-2 study drug. \\\\\n- End of study drug (phase out). \\\\\nPhone Visit and End of Study (14 Days Post Study Visit 3) \\\\\n- A final phone visit is conducted to assess for adverse events.\n\\end{tabular} 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filling pressures during","text_display":" major barrier to treatment in HFpEF, \\({ }^{10}\\) because interventions that reduce filling pressures during","confidence":0.9833984375,"confidence_rate":0.9998518613021083},{"cnt":[[245,2299],[1803,2299],[1803,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2298,"width":1559,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1c6a347b30b54a4ca04358c37ecb7153","type":"text","conversion_output":true,"text":"exercise also reduce resting pressures, increasing the vulnerability to hypotension in people","text_display":" exercise also reduce resting pressures, increasing the vulnerability to hypotension in people","confidence":1,"confidence_rate":1},{"cnt":[[245,2350],[1818,2350],[1818,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2350,"width":1574,"height":50},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"65855d3e6c734b3798db040d2f5baf8f","type":"text","conversion_output":true,"text":"with HFpEF. \\({ }^{18}\\) It has recently been pointed out that HFpEF is a heterogenous syndrome and","text_display":" with HFpEF. \\({ }^{18}\\) It has recently been pointed out that HFpEF is a heterogenous syndrome and","confidence":0.97802734375,"confidence_rate":0.9997863915627857},{"cnt":[[245,2400],[1863,2400],[1863,2449],[245,2449]],"region":{"top_left_x":244,"top_left_y":2399,"width":1619,"height":51},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b5bc2f74614c4512a53e5fe8b215e236","type":"text","conversion_output":true,"text":"that this may explain the failure of previous trials testing therapies that are efficacious in HFrEF.","text_display":" that this may explain the failure of previous trials testing therapies that are efficacious in HFrEF.","confidence":0.99951171875,"confidence_rate":0.9999953924587458},{"cnt":[[245,2449],[1807,2449],[1807,2499],[245,2499]],"region":{"top_left_x":244,"top_left_y":2449,"width":1563,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78269eba5f994d5098fa2326510f6ff6","type":"text","conversion_output":true,"text":"However, elevation in left ventricular filling pressures and pulmonary artery pressures during","text_display":" However, elevation in left ventricular filling pressures and pulmonary artery pressures 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contributes to symptoms and thus represents a","confidence":0.5849609375,"confidence_rate":0.9947568308290843},{"cnt":[[243,249],[1725,249],[1725,299],[243,299]],"region":{"top_left_x":242,"top_left_y":249,"width":1484,"height":50},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b6ac68ee1dd34d6baca033f57cbf8cec","type":"text","conversion_output":true,"text":"viable target. Other abnormalities including limited cardiac output reserve or peripheral","text_display":" viable target. Other abnormalities including limited cardiac output reserve or peripheral","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1154,301],[1154,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":910,"height":51},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a128a99591ff422d8f4bfa13625e692b","type":"text","conversion_output":true,"text":"limitations may apply to some patients but not others.","text_display":" limitations may apply to some patients but not others.","confidence":0.99951171875,"confidence_rate":0.9999917220597181},{"cnt":[[245,372],[1876,372],[1876,421],[245,421]],"region":{"top_left_x":244,"top_left_y":371,"width":1632,"height":51},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"95a226d55b574445a42f41760a1c76c3","type":"text","conversion_output":true,"text":"Improving hemodynamics by enhancing nitric oxide signaling in HFpEF: Nitric oxide-cyclic","text_display":"\n\nImproving hemodynamics by enhancing nitric oxide signaling in HFpEF: Nitric oxide-cyclic","confidence":1,"confidence_rate":1},{"cnt":[[245,423],[1826,423],[1826,473],[245,473]],"region":{"top_left_x":244,"top_left_y":423,"width":1583,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"722548ae17ff41a2b63e7e31e9fe16e6","type":"text","conversion_output":true,"text":"guanosine monophosphate (NO-cGMP) dependent, flow-mediated vasodilation is impaired in","text_display":" guanosine monophosphate (NO-cGMP) dependent, flow-mediated vasodilation is impaired in","confidence":1,"confidence_rate":1},{"cnt":[[245,473],[1835,473],[1835,522],[245,522]],"region":{"top_left_x":244,"top_left_y":472,"width":1591,"height":51},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d5bbf37710754f36a388cfd3293aa42a","type":"text","conversion_output":true,"text":"people with HFpEF. \\({ }^{9}\\) Intriguingly, the magnitude of impaired vasodilation is directly correlated","text_display":" people with HFpEF. \\({ }^{9}\\) Intriguingly, the magnitude of impaired vasodilation is directly correlated","confidence":1,"confidence_rate":1},{"cnt":[[245,524],[1772,524],[1772,574],[245,574]],"region":{"top_left_x":244,"top_left_y":524,"width":1529,"height":50},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f95b5f7a8567495398c514b9223289f0","type":"text","conversion_output":true,"text":"with severity of dyspnea and fatigue during submaximal exercise, as well as the degree of","text_display":" with severity of dyspnea and fatigue during submaximal exercise, as well as the degree of","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,576],[1858,576],[1858,625],[245,625]],"region":{"top_left_x":244,"top_left_y":575,"width":1615,"height":51},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"3890826d052b4a3fa9b1ee9d3449bdee","type":"text","conversion_output":true,"text":"reduction in exercise capacity. Cardiomyocyte studies from human tissue have shown that NO-","text_display":" reduction in exercise capacity. 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Inorganic nitrate-nitrite represents a novel candidate molecule to","text_display":" SOCRATES-preserved). Inorganic nitrate-nitrite represents a novel candidate molecule to","confidence":1,"confidence_rate":1},{"cnt":[[245,1051],[1820,1051],[1820,1102],[245,1102]],"region":{"top_left_x":244,"top_left_y":1050,"width":1576,"height":53},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19259aa2ef4642e99263f9ca33916a7f","type":"text","conversion_output":true,"text":"preferentially restore NO-cGMP signaling during exercise stress, since reduction of inorganic","text_display":" preferentially restore NO-cGMP signaling during exercise stress, since reduction of inorganic","confidence":1,"confidence_rate":1},{"cnt":[[245,1100],[1742,1100],[1742,1149],[245,1149]],"region":{"top_left_x":244,"top_left_y":1100,"width":1499,"height":50},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f1cb5f0546ae41d1bc30eec5a7194a26","type":"text","conversion_output":true,"text":"nitrite to NO is enhanced in the setting of tissue hypoxia and acidosis, as develop during","text_display":" nitrite to NO is enhanced in the setting of tissue hypoxia and acidosis, as develop during","confidence":1,"confidence_rate":1},{"cnt":[[245,1152],[406,1152],[406,1197],[245,1197]],"region":{"top_left_x":244,"top_left_y":1151,"width":163,"height":46},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d14c795e9813471585bba04439a4442d","type":"text","conversion_output":true,"text":"exercise.","text_display":" exercise.","confidence":1,"confidence_rate":1},{"cnt":[[245,1222],[1876,1222],[1876,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1222,"width":1632,"height":53},"line":20,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8ce4c0a26b3d4e0c9caa9befcf56add5","type":"text","conversion_output":true,"text":"Exercise capacity is a clinically-meaningful, patient-centric endpoint in HF trials: Exercise","text_display":"\n\nExercise capacity is a clinically-meaningful, patient-centric endpoint in HF trials: Exercise","confidence":0.705078125,"confidence_rate":0.9964405675387812},{"cnt":[[245,1272],[1714,1272],[1714,1321],[245,1321]],"region":{"top_left_x":244,"top_left_y":1271,"width":1471,"height":51},"line":21,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d821922ffff34e21ba6d563511242bc3","type":"text","conversion_output":true,"text":"intolerance is the ultimate symptomatic manifestation of HFpEF and can be objectively","text_display":" intolerance is the ultimate symptomatic manifestation of HFpEF and can be objectively","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[245,1319],[1807,1319],[1807,1373],[245,1373]],"region":{"top_left_x":244,"top_left_y":1319,"width":1563,"height":54},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"f38064455d304b3bae0d9acf01df8127","type":"text","conversion_output":true,"text":"quantified by measurement of peak \\(VO _{2} .{ }^{21}\\) Cardiopulmonary exercise testing (CPET), unlike","text_display":" quantified by measurement of peak \\(VO _{2} .{ }^{21}\\) Cardiopulmonary exercise testing (CPET), unlike","confidence":0.9785454177763313,"confidence_rate":0.9998080885279028},{"cnt":[[245,1375],[1796,1375],[1796,1424],[245,1424]],"region":{"top_left_x":244,"top_left_y":1375,"width":1553,"height":50},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c653be3985724504badd3e283937dde6","type":"text","conversion_output":true,"text":"other measures such as 6-minute walk distance (6 MWD), permits direct assessment of the","text_display":" other measures such as 6-minute walk distance (6 MWD), permits direct assessment of the","confidence":0.5058297049254179,"confidence_rate":0.9926191642525406},{"cnt":[[245,1422],[1828,1422],[1828,1474],[245,1474]],"region":{"top_left_x":244,"top_left_y":1422,"width":1585,"height":52},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"4a3daf8720e347b2846fd7fc940cf4b2","type":"text","conversion_output":true,"text":"organ system limiting gas exchange. This is crucial in people with HFpEF who are older-aged","text_display":" organ system limiting gas exchange. This is crucial in people with HFpEF who are older-aged","confidence":1,"confidence_rate":1},{"cnt":[[245,1474],[1747,1474],[1747,1523],[245,1523]],"region":{"top_left_x":244,"top_left_y":1473,"width":1503,"height":51},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"be4c5269aebb41c281ba1359d8ca9543","type":"text","conversion_output":true,"text":"and often display pulmonary, mechanical, or orthopedic limitations to exercise that might","text_display":" and often display pulmonary, mechanical, or orthopedic limitations to exercise that might","confidence":1,"confidence_rate":1},{"cnt":[[245,1525],[1837,1525],[1837,1575],[245,1575]],"region":{"top_left_x":244,"top_left_y":1525,"width":1593,"height":50},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77854716ae3949f9869087e5da50af04","type":"text","conversion_output":true,"text":"contribute to low 6 MWD. CPET also allows for assessment of the adequacy of exercise effort","text_display":" contribute to low 6 MWD. 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protocol as the intravenous nitrite study above. \\({ }^{45}\\) Inhaled nitrite","text_display":"\nexercise, using the same protocol as the intravenous nitrite study above. \\({ }^{45}\\) Inhaled nitrite","confidence":1,"confidence_rate":1},{"cnt":[[245,2322],[1755,2322],[1755,2370],[245,2370]],"region":{"top_left_x":244,"top_left_y":2322,"width":1512,"height":48},"line":56,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a40d0a72a3554181a205456c81b4edb2","type":"text","conversion_output":true,"text":"therapy produced similar increases in plasma nitrite levels as the intravenous formulation","text_display":" therapy produced similar increases in plasma nitrite levels as the intravenous formulation","confidence":0.99853515625,"confidence_rate":0.9999845694066055},{"cnt":[[245,2372],[1869,2372],[1869,2421],[245,2421]],"region":{"top_left_x":244,"top_left_y":2371,"width":1626,"height":51},"line":57,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f9fdeb7d0fc4cba86c47ad3e6645de4","type":"text","conversion_output":true,"text":"(Figure 6A), with similar reductions in PCWP at rest and during exercise as was observed in the","text_display":" (Figure 6A), with similar reductions in PCWP at rest and during exercise as was observed in the","confidence":0.99951171875,"confidence_rate":0.9999951160069457},{"cnt":[[245,2423],[763,2423],[763,2473],[245,2473]],"region":{"top_left_x":244,"top_left_y":2423,"width":519,"height":50},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"243b5749a176433288dec8c9cea8167e","type":"text","conversion_output":true,"text":"intravenous study (Figure 6B).","text_display":" intravenous study 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(Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1822,2539],[1869,2539],[1869,2574],[1822,2574]],"region":{"top_left_x":1821,"top_left_y":2539,"width":49,"height":35},"line":60,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"dab588e2ffdd4afd86472d271cf843c9","type":"page_info","conversion_output":false,"text":"17","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"2797815c-2843-46aa-81fc-4fe2b5548cd2-18","page":18,"lines":[{"cnt":[[245,247],[1833,247],[1833,299],[245,299]],"region":{"top_left_x":244,"top_left_y":247,"width":1589,"height":52},"line":1,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"763079a1d8b5417b87df0b75080f5d80","type":"text","conversion_output":true,"text":"In the HFpEF exercise studies of both Zamani et al. \\({ }^{44}\\) and Borlaug et al. \\({ }^{45}\\) there was improved","text_display":"\n\nIn the HFpEF exercise studies of both Zamani et al. \\({ }^{44}\\) and Borlaug et al. \\({ }^{45}\\) there was improved","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1717,301],[1717,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1473,"height":51},"line":2,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79399026621244ddac3a8b5e54a5c987","type":"text","conversion_output":true,"text":"vasodilation (reduction in systemic vascular resistance) with exercise but no significant","text_display":" vasodilation (reduction in systemic vascular resistance) with exercise but no significant","confidence":1,"confidence_rate":1},{"cnt":[[245,352],[1747,352],[1747,400],[245,400]],"region":{"top_left_x":244,"top_left_y":352,"width":1503,"height":48},"line":3,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"50afd42262f544f78f70a95ef625b4ff","type":"text","conversion_output":true,"text":"decrease in blood pressure with nitrate/nitrite, in contrast to marked reductions in arterial","text_display":" decrease in blood pressure with nitrate/nitrite, in contrast to marked reductions in arterial","confidence":1,"confidence_rate":1},{"cnt":[[245,400],[1820,400],[1820,451],[245,451]],"region":{"top_left_x":244,"top_left_y":399,"width":1576,"height":53},"line":4,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"861450516f75428181b80eca201543b5","type":"text","conversion_output":true,"text":"pressure previously noted with organic nitrates in HFpEF. \\({ }^{18}\\) Nitrite infusion achieving plasma","text_display":" pressure previously noted with organic nitrates in HFpEF. \\({ }^{18}\\) Nitrite infusion achieving plasma","confidence":1,"confidence_rate":1},{"cnt":[[245,451],[1854,451],[1854,501],[245,501]],"region":{"top_left_x":244,"top_left_y":451,"width":1611,"height":50},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"1a477ada128c46c8b0b29e82da3c7477","type":"text","conversion_output":true,"text":"levels \\(30 \\%\\) higher than what will be tested in INDIE-HF had no effect on arterial blood pressure","text_display":" levels \\(30 \\%\\) higher than what will be tested in INDIE-HF had no effect on arterial blood pressure","confidence":0.9926819801330566,"confidence_rate":0.9999286925625881},{"cnt":[[245,501],[1160,501],[1160,552],[245,552]],"region":{"top_left_x":244,"top_left_y":500,"width":917,"height":53},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"a7c8d1d46b744b229b76b806454a95a5","type":"text","conversion_output":true,"text":"in a study of primates \\((95 \\pm 3\\) vs \\(98 \\pm 2 mmHg , p =0.8) .^{37}\\)","text_display":" in a study of primates \\((95 \\pm 3\\) vs \\(98 \\pm 2 mmHg , p =0.8) .^{37}\\)","confidence":0.5535547861741568,"confidence_rate":0.9915870946520693},{"cnt":[[245,604],[1865,604],[1865,655],[245,655]],"region":{"top_left_x":244,"top_left_y":603,"width":1621,"height":53},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6ccfa39870064143a33c1883ad541d1f","type":"text","conversion_output":true,"text":"Inhaled nitrite has been administered at a dose of 90 mg three times daily in healthy volunteers,","text_display":"\n\nInhaled nitrite has been administered at a dose of 90 mg three times daily in healthy volunteers,","confidence":0.99951171875,"confidence_rate":0.9999954355197808},{"cnt":[[245,653],[1828,653],[1828,703],[245,703]],"region":{"top_left_x":244,"top_left_y":653,"width":1585,"height":50},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"266285f75c9442539c5fef9cd55344f7","type":"text","conversion_output":true,"text":"with no hypotension and no orthostatic intolerance. \\({ }^{46}\\) In an unpublished, open label study, 29","text_display":" with no hypotension and no orthostatic intolerance. \\({ }^{46}\\) In an unpublished, open label study, 29","confidence":0.99951171875,"confidence_rate":0.9999954777833909},{"cnt":[[245,705],[1807,705],[1807,754],[245,754]],"region":{"top_left_x":244,"top_left_y":704,"width":1563,"height":51},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e1daf4fb0c79468dad7ffe14b765683e","type":"text","conversion_output":true,"text":"patients with Group 1 pulmonary hypertension were treated with inhaled nitrite for 16 weeks,","text_display":" patients with Group 1 pulmonary hypertension were treated with inhaled nitrite for 16 weeks,","confidence":0.9970703125,"confidence_rate":0.9999715150908018},{"cnt":[[245,752],[1828,752],[1828,804],[245,804]],"region":{"top_left_x":244,"top_left_y":751,"width":1585,"height":53},"line":10,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ffa6ab931cc64e169ec2c73652b0d9ec","type":"text","conversion_output":true,"text":"with open label extension out to 57 weeks. \\({ }^{47}\\) There were no withdrawals and no symptomatic","text_display":" with open label extension out to 57 weeks. \\({ }^{47}\\) There were no withdrawals and no symptomatic","confidence":1,"confidence_rate":1},{"cnt":[[245,804],[1811,804],[1811,855],[245,855]],"region":{"top_left_x":244,"top_left_y":803,"width":1568,"height":53},"line":11,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"84e2de6d4c0041fd899755d8cba59faf","type":"text","conversion_output":true,"text":"hypotensive episodes. In this trial, systolic blood pressure was unchanged during treatment,","text_display":" hypotensive episodes. In this trial, systolic blood pressure was unchanged during treatment,","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1863,855],[1863,907],[245,907]],"region":{"top_left_x":244,"top_left_y":855,"width":1619,"height":52},"line":12,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e92e584827c642b4bbb6354027d6960b","type":"text","conversion_output":true,"text":"from \\(117(95 \\% Cl : 108,126) mmHg\\) at study entry to \\(114(107,121) mmHg\\) at study completion","text_display":" from \\(117(95 \\% Cl : 108,126) mmHg\\) at study entry to \\(114(107,121) mmHg\\) at study completion","confidence":0.9217520285892808,"confidence_rate":0.999201504838948},{"cnt":[[245,907],[1871,907],[1871,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1628,"height":51},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b72d10984bb34600a80d3b09a86f0ab8","type":"text","conversion_output":true,"text":"( \\(p =\\) NS). Diastolic pressure similarly remained unchanged from \\(74(68,80) mmHg\\) to \\(73(67,78)\\)","text_display":" ( \\(p =\\) NS). Diastolic pressure similarly remained unchanged from \\(74(68,80) mmHg\\) to \\(73(67,78)\\)","confidence":0.46665248006212323,"confidence_rate":0.9927675150021856},{"cnt":[[245,958],[849,958],[849,1008],[245,1008]],"region":{"top_left_x":244,"top_left_y":958,"width":605,"height":50},"line":14,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"77341feff71e4f1bab8d7ca112fe6b96","type":"text","conversion_output":true,"text":"mmHg at study completion ( \\(p = NS\\) ).","text_display":" mmHg at study completion ( \\(p = NS\\) ).","confidence":0.89501953125,"confidence_rate":0.9977842636095621},{"cnt":[[236,1066],[827,1066],[827,1128],[236,1128]],"region":{"top_left_x":236,"top_left_y":1065,"width":592,"height":63},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7799162dde264cfb8814c94f7bbae919","type":"section_header","conversion_output":false,"children_ids":["6c2f971ca0a04c3491fc454a650eba0d"],"text":"","text_display":""},{"cnt":[[245,1072],[821,1072],[821,1121],[245,1121]],"region":{"top_left_x":244,"top_left_y":1072,"width":577,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c2f971ca0a04c3491fc454a650eba0d","type":"text","conversion_output":true,"parent_id":"7799162dde264cfb8814c94f7bbae919","text":"7 BASIC STUDY DESIGN","text_display":"\n\n\\section*{7 BASIC STUDY DESIGN}","confidence":0.99951171875,"confidence_rate":0.9999796501863057},{"cnt":[[245,1171],[1830,1171],[1830,1222],[245,1222]],"region":{"top_left_x":244,"top_left_y":1170,"width":1587,"height":53},"line":17,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"ef3326bf147e4d5791b252dbab64739f","type":"text","conversion_output":true,"text":"The INDIE-HFpEF study is a randomized, double-blind, placebo-controlled crossover study to","text_display":"\n\nThe INDIE-HFpEF study is a randomized, double-blind, placebo-controlled crossover study to","confidence":1,"confidence_rate":1},{"cnt":[[245,1222],[1777,1222],[1777,1274],[245,1274]],"region":{"top_left_x":244,"top_left_y":1222,"width":1533,"height":53},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cd8537a0cf93470581d39dc2aa74beba","type":"text","conversion_output":true,"text":"assess the effect of inorganic nitrite on peak exercise capacity (peak \\(VO _{2}\\) ) as assessed by","text_display":" assess the effect of inorganic nitrite on peak exercise capacity (peak \\(VO _{2}\\) ) as assessed by","confidence":0.9586637634783983,"confidence_rate":0.999612782536899},{"cnt":[[245,1272],[960,1272],[960,1326],[245,1326]],"region":{"top_left_x":244,"top_left_y":1271,"width":717,"height":55},"line":19,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"afa7808ef2d84d1f94396721a3f236f4","type":"text","conversion_output":true,"text":"cardiopulmonary exercise testing (CPET).","text_display":" cardiopulmonary exercise testing (CPET).","confidence":1,"confidence_rate":1},{"cnt":[[236,1371],[737,1371],[737,1437],[236,1437]],"region":{"top_left_x":236,"top_left_y":1370,"width":501,"height":68},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2e7a0a95adb42499adebd154949e063","type":"section_header","conversion_output":false,"children_ids":["46f68bea382b46668e756ee98ecc46c0"],"text":"","text_display":""},{"cnt":[[245,1379],[728,1379],[728,1429],[245,1429]],"region":{"top_left_x":244,"top_left_y":1379,"width":485,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46f68bea382b46668e756ee98ecc46c0","type":"text","conversion_output":true,"parent_id":"e2e7a0a95adb42499adebd154949e063","text":"7.1 Screening / Baseline","text_display":"\n\n\\subsection*{7.1 Screening / Baseline}","confidence":0.998046875,"confidence_rate":0.9999325872780016},{"cnt":[[245,1448],[1841,1448],[1841,1502],[245,1502]],"region":{"top_left_x":244,"top_left_y":1448,"width":1598,"height":54},"line":22,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"5a0413bab3b944a3b4a837b65d34a45e","type":"text","conversion_output":true,"text":"Patients with a diagnosis of HFpEF are screened for entry criteria. Willing participants meeting","text_display":"\n\nPatients with a diagnosis of HFpEF are screened for entry criteria. Willing participants meeting","confidence":0.55810546875,"confidence_rate":0.9942423094761013},{"cnt":[[245,1500],[1807,1500],[1807,1551],[245,1551]],"region":{"top_left_x":244,"top_left_y":1499,"width":1563,"height":53},"line":23,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"e6f150cabd094fc8bda09caa3020035a","type":"text","conversion_output":true,"text":"entry criteria will be consented and questioned to confirm that HF symptoms are the primary","text_display":" entry criteria will be consented and questioned to confirm that HF symptoms are the primary","confidence":0.9951171875,"confidence_rate":0.9999490140875682},{"cnt":[[245,1551],[1858,1551],[1858,1601],[245,1601]],"region":{"top_left_x":244,"top_left_y":1551,"width":1615,"height":50},"line":24,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"6a455448472547f0b703a53e7e5498ad","type":"text","conversion_output":true,"text":"limitation to activity. If the participant does not meet this criteria, they will be considered screen","text_display":" limitation to activity. If the participant does not meet this criteria, they will be considered screen","confidence":1,"confidence_rate":1},{"cnt":[[245,1603],[743,1603],[743,1648],[245,1648]],"region":{"top_left_x":244,"top_left_y":1602,"width":500,"height":46},"line":25,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"79de01ad5ce0409f9e716583307fc85b","type":"text","conversion_output":true,"text":"failures and will not continue.","text_display":" failures and will not continue.","confidence":1,"confidence_rate":1},{"cnt":[[245,1704],[1846,1704],[1846,1755],[245,1755]],"region":{"top_left_x":244,"top_left_y":1703,"width":1602,"height":53},"line":26,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"b45db94483cf4cd8a541d01c1d1828f0","type":"text","conversion_output":true,"text":"All consented participants continuing to meet the screening criteria will undergo baseline blood","text_display":"\n\nAll consented participants continuing to meet the screening criteria will undergo baseline blood","confidence":1,"confidence_rate":1},{"cnt":[[245,1753],[1837,1753],[1837,1803],[245,1803]],"region":{"top_left_x":244,"top_left_y":1753,"width":1593,"height":50},"line":27,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"35132da876c84a8bab916de34e3deb0b","type":"text","conversion_output":true,"text":"draws to include complete blood count (CBC), complete chemistry panel (Sodium, Potassium,","text_display":" draws to include complete blood count (CBC), complete chemistry panel (Sodium, Potassium,","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[245,1805],[1824,1805],[1824,1854],[245,1854]],"region":{"top_left_x":244,"top_left_y":1804,"width":1581,"height":51},"line":28,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"64711a1fd0fc4f129fb26d059d73b964","type":"text","conversion_output":true,"text":"Chloride, Carbon Dioxide, BUN, Creatinine, Glucose, AL, AST, Alkaline Phosphatase \\& Total","text_display":" Chloride, Carbon Dioxide, BUN, Creatinine, Glucose, AL, AST, Alkaline Phosphatase \\& Total","confidence":1,"confidence_rate":1},{"cnt":[[245,1852],[1869,1852],[1869,1906],[245,1906]],"region":{"top_left_x":244,"top_left_y":1851,"width":1626,"height":55},"line":29,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7ef658b6166d4b3f8e7fa10877f8b4ff","type":"text","conversion_output":true,"text":"Bilirubin), HFN biomarkers (cystatin C, NT-proBNP, cGMP and nitrosothiols), HFN biorepository","text_display":" Bilirubin), HFN biomarkers (cystatin C, NT-proBNP, cGMP and nitrosothiols), HFN biorepository","confidence":1,"confidence_rate":1},{"cnt":[[245,1904],[1760,1904],[1760,1955],[245,1955]],"region":{"top_left_x":244,"top_left_y":1903,"width":1516,"height":53},"line":30,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7a0d35fc6bc545048855e8c2f6e091e0","type":"text","conversion_output":true,"text":"and genetics samples (if agreed to participate). Afterwards, the participant will undergo a","text_display":" and genetics samples (if agreed to participate). 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If the participant does not meet the CPET criteria, they will be considered screen","text_display":" ratio \\(\\geq 1.0\\). If the participant does not meet the CPET criteria, they will be considered screen","confidence":1,"confidence_rate":1},{"cnt":[[245,2058],[741,2058],[741,2103],[245,2103]],"region":{"top_left_x":244,"top_left_y":2058,"width":498,"height":46},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"992a1c9e56f54409b5bb8cb07e79f7b8","type":"text","conversion_output":true,"text":"failures and will not continue.","text_display":" failures and will not continue.","confidence":1,"confidence_rate":1},{"cnt":[[245,2157],[1837,2157],[1837,2206],[245,2206]],"region":{"top_left_x":244,"top_left_y":2157,"width":1593,"height":50},"line":34,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"83cae26d24c74a759bdfbbcd35409b73","type":"text","conversion_output":true,"text":"For participants that meet the above criteria, the remaining baseline studies will be performed:","text_display":"\n\nFor participants that meet the above criteria, the remaining baseline studies will be performed:","confidence":1,"confidence_rate":1},{"cnt":[[245,2209],[1439,2209],[1439,2258],[245,2258]],"region":{"top_left_x":244,"top_left_y":2208,"width":1196,"height":51},"line":35,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"eab7efe17dc947a2936bf733c7e91ba6","type":"text","conversion_output":true,"text":"history and physical exam, NYHA class assessment, ECG and KCCQ.","text_display":" history and physical exam, NYHA class assessment, ECG and KCCQ.","confidence":1,"confidence_rate":1},{"cnt":[[245,2310],[1811,2310],[1811,2357],[245,2357]],"region":{"top_left_x":244,"top_left_y":2309,"width":1568,"height":48},"line":36,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"61f852985f8f4346b5a2d7d0f66739c5","type":"text","conversion_output":true,"text":"Note: The baseline bloods are to be done prior to the CPET as the biomarker values can be","text_display":"\n\nNote: The baseline bloods are to be done prior to the CPET as the biomarker values can be","confidence":1,"confidence_rate":1},{"cnt":[[245,2359],[1807,2359],[1807,2408],[245,2408]],"region":{"top_left_x":244,"top_left_y":2358,"width":1563,"height":51},"line":37,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"24f21c008e01449aabb0dddc5a1378ae","type":"text","conversion_output":true,"text":"affected from the exertion of the CPET. 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If the seated SBP is","text_display":" Just prior to this test dose, a seated and standing BP must be obtained. If the seated SBP is","confidence":1,"confidence_rate":1},{"cnt":[[245,352],[1820,352],[1820,402],[245,402]],"region":{"top_left_x":244,"top_left_y":352,"width":1576,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f348025c71714aa38a297966da3273b7","type":"text","conversion_output":true,"text":"\\(<115 mmHg\\) or the standing SBP is \\(<90 mmHg\\) the patient is considered a screen failure and","text_display":" \\(<115 mmHg\\) or the standing SBP is \\(<90 mmHg\\) the patient is considered a screen failure and","confidence":1,"confidence_rate":1},{"cnt":[[245,404],[801,404],[801,449],[245,449]],"region":{"top_left_x":244,"top_left_y":403,"width":558,"height":47},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d1e717adb304be49953f0bd76d18b50","type":"text","conversion_output":true,"text":"should not receive the test dose.","text_display":" should not receive the test dose.","confidence":1,"confidence_rate":1},{"cnt":[[245,503],[1811,503],[1811,552],[245,552]],"region":{"top_left_x":244,"top_left_y":502,"width":1568,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d9c8b5c3ab0746fd800d513d80bcaf2d","type":"text","conversion_output":true,"text":"Participants that pass the SBP criteria will receive one full dose ( 80 mg ) of nebulized sodium","text_display":"\n\nParticipants that pass the SBP criteria will receive one full dose ( 80 mg ) of nebulized sodium","confidence":0.8662109375,"confidence_rate":0.9986459475263882},{"cnt":[[245,554],[1760,554],[1760,604],[245,604]],"region":{"top_left_x":244,"top_left_y":554,"width":1516,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20e1f01314054f90b4b79a2fb3c6d0a1","type":"text","conversion_output":true,"text":"nitrite with monitoring for 60 minutes following dosage for adverse effects or symptomatic","text_display":" nitrite with monitoring for 60 minutes following dosage for adverse effects or symptomatic","confidence":1,"confidence_rate":1},{"cnt":[[245,604],[1867,604],[1867,655],[245,655]],"region":{"top_left_x":244,"top_left_y":603,"width":1623,"height":53},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8e58341e3b294bbc9fd2b980400e9b19","type":"text","conversion_output":true,"text":"hypotension. Systemic blood pressures will be monitored (seated and 3 minutes after standing)","text_display":" hypotension. Systemic blood pressures will be monitored (seated and 3 minutes after standing)","confidence":1,"confidence_rate":1},{"cnt":[[245,653],[1863,653],[1863,707],[245,707]],"region":{"top_left_x":244,"top_left_y":653,"width":1619,"height":54},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dae4936ddca746f58541c4db39da5742","type":"text","conversion_output":true,"text":"every 15 minutes for 60 minutes. Participants developing hypotension (SBP \\(<90 mmHg\\) seated","text_display":" every 15 minutes for 60 minutes. Participants developing hypotension (SBP \\(<90 mmHg\\) seated","confidence":0.979074178612791,"confidence_rate":0.999798611999916},{"cnt":[[245,705],[1835,705],[1835,754],[245,754]],"region":{"top_left_x":244,"top_left_y":704,"width":1591,"height":51},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2e40b7e7971343cfa0325886b030bf40","type":"text","conversion_output":true,"text":"OR standing), lightheadedness, or who otherwise do not tolerate the single-dose run-in will be","text_display":" OR standing), lightheadedness, or who otherwise do not tolerate the single-dose run-in will be","confidence":1,"confidence_rate":1},{"cnt":[[245,756],[1156,756],[1156,801],[245,801]],"region":{"top_left_x":244,"top_left_y":756,"width":912,"height":46},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9a34ef0f4f44cbea1af15396c797298","type":"text","conversion_output":true,"text":"considered run-in failures and will not be randomized.","text_display":" considered run-in failures and will not be randomized.","confidence":1,"confidence_rate":1},{"cnt":[[243,859],[634,859],[634,909],[243,909]],"region":{"top_left_x":242,"top_left_y":859,"width":392,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7fda3d873a34d808ecf1c4777374e36","type":"section_header","conversion_output":false,"children_ids":["940392a93797432ca61a4142aa84a536"],"text":"","text_display":""},{"cnt":[[249,864],[629,864],[629,904],[249,904]],"region":{"top_left_x":249,"top_left_y":863,"width":381,"height":42},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"940392a93797432ca61a4142aa84a536","type":"text","conversion_output":true,"parent_id":"a7fda3d873a34d808ecf1c4777374e36","text":"7.2 Randomization","text_display":"\n\n\\subsection*{7.2 Randomization}","confidence":1,"confidence_rate":1},{"cnt":[[245,932],[1835,932],[1835,982],[245,982]],"region":{"top_left_x":244,"top_left_y":932,"width":1591,"height":50},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"62afa25a8c41400482052a72f61542b8","type":"text","conversion_output":true,"text":"Eligible patients successfully completing baseline and run-in activities will then be randomized","text_display":"\n\nEligible patients successfully completing baseline and run-in activities will then be randomized","confidence":1,"confidence_rate":1},{"cnt":[[245,982],[1796,982],[1796,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":981,"width":1553,"height":53},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50ef581c68784952a5675f91d7bb8f16","type":"text","conversion_output":true,"text":"using procedures determined by the Coordinating Center (CC) to one of 2 treatment groups","text_display":" using procedures determined by the Coordinating Center (CC) to one of 2 treatment groups","confidence":0.9960973262786865,"confidence_rate":0.9999592684438828},{"cnt":[[245,1033],[1721,1033],[1721,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1033,"width":1477,"height":52},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1290aa2917a24ffb83961f0baa9da7d1","type":"text","conversion_output":true,"text":"(placebo first with crossover to inorganic nitrite or inorganic nitrite first with crossover to","text_display":" (placebo first with crossover to inorganic nitrite or inorganic nitrite first with crossover to","confidence":1,"confidence_rate":1},{"cnt":[[245,1083],[1764,1083],[1764,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1082,"width":1520,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"35421653f4ae41eeb772eca374e3474f","type":"text","conversion_output":true,"text":"placebo). A permuted block randomization method stratified by site will be used to ensure","text_display":" placebo). A permuted block randomization method stratified by site will be used to ensure","confidence":1,"confidence_rate":1},{"cnt":[[245,1134],[1571,1134],[1571,1184],[245,1184]],"region":{"top_left_x":244,"top_left_y":1134,"width":1327,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90ef87c4c7a945a9b6c9e2cb4720eb1b","type":"text","conversion_output":true,"text":"relatively equal distribution of participants to each arm within each clinical site.","text_display":" relatively equal distribution of participants to each arm within each clinical site.","confidence":0.99853515625,"confidence_rate":0.9999835291504493},{"cnt":[[245,1238],[1858,1238],[1858,1287],[245,1287]],"region":{"top_left_x":244,"top_left_y":1237,"width":1615,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fbe27299e2a84589993718312bf575cb","type":"text","conversion_output":true,"text":"Following randomization, participants will receive training in use of the nebulizer device and the","text_display":"\n\nFollowing randomization, participants will receive training in use of the nebulizer device and the","confidence":1,"confidence_rate":1},{"cnt":[[245,1289],[1833,1289],[1833,1336],[245,1336]],"region":{"top_left_x":244,"top_left_y":1289,"width":1589,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6fa6137999fb49b69f32011d8e5ccd6d","type":"text","conversion_output":true,"text":"accelerometry belt. Participants will be required to demonstrate capability to administer study","text_display":" accelerometry belt. Participants will be required to demonstrate capability to administer study","confidence":1,"confidence_rate":1},{"cnt":[[245,1336],[1618,1336],[1618,1386],[245,1386]],"region":{"top_left_x":244,"top_left_y":1336,"width":1374,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"39e73dc33c22494f965c065f51d3a51c","type":"text","conversion_output":true,"text":"drug using the nebulizer device on their own prior to dismissal from Study Visit 1.","text_display":" drug using the nebulizer device on their own prior to dismissal from Study Visit 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per day during the active portion of the participant's day.","confidence":1,"confidence_rate":1},{"cnt":[[402,1929],[1734,1929],[1734,1974],[402,1974]],"region":{"top_left_x":401,"top_left_y":1929,"width":1333,"height":46},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5a745f0078ef46fa8ba35082c13bd7df","type":"text","conversion_output":true,"text":"Participants will be encouraged to call study staff promptly to report any adverse","text_display":" Participants will be encouraged to call study staff promptly to report any adverse","confidence":1,"confidence_rate":1},{"cnt":[[402,1972],[569,1972],[569,2013],[402,2013]],"region":{"top_left_x":401,"top_left_y":1972,"width":169,"height":42},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18455f1577844c738e5fee75dde7c089","type":"text","conversion_output":true,"text":"reactions.","text_display":" 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One of the following:","confidence":1,"confidence_rate":1},{"cnt":[[432,920],[1796,920],[1796,969],[432,969]],"region":{"top_left_x":431,"top_left_y":919,"width":1366,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c723a098c6764570ab7f5bc0f32c4ade","type":"text","conversion_output":true,"text":"- Previous hospitalization for HF with radiographic evidence (pulmonary venous","text_display":"\n- Previous hospitalization for HF with radiographic evidence (pulmonary venous","confidence":1,"confidence_rate":1},{"cnt":[[494,971],[1706,971],[1706,1021],[494,1021]],"region":{"top_left_x":494,"top_left_y":971,"width":1212,"height":50},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e629b67ce98b454e89edce02b222d7cb","type":"text","conversion_output":true,"text":"hypertension, vascular congestion, interstitial edema, pleural effusion) of","text_display":" hypertension, vascular congestion, interstitial edema, pleural effusion) of","confidence":1,"confidence_rate":1},{"cnt":[[494,1023],[924,1023],[924,1072],[494,1072]],"region":{"top_left_x":494,"top_left_y":1022,"width":430,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b341d41d87245f08908eb33fcf6793e","type":"text","conversion_output":true,"text":"pulmonary congestion or","text_display":" pulmonary congestion or","confidence":1,"confidence_rate":1},{"cnt":[[432,1074],[1764,1074],[1764,1124],[432,1124]],"region":{"top_left_x":431,"top_left_y":1074,"width":1333,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"de91b85b2c2a460f821a641496da15f9","type":"text","conversion_output":true,"text":"- Catheterization documented elevated filling pressures at rest (PCWP \\(\\geq 15\\) or","text_display":"\n- Catheterization documented elevated filling pressures at rest (PCWP \\(\\geq 15\\) or","confidence":1,"confidence_rate":1},{"cnt":[[494,1121],[1257,1121],[1257,1175],[494,1175]],"region":{"top_left_x":494,"top_left_y":1121,"width":763,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a405fe75027428eb9d72bfc4d9b21d0","type":"text","conversion_output":true,"text":"LVEDP \\(\\geq 18\\) ) or with exercise (PCWP \\(\\geq 25\\) ) or","text_display":" LVEDP \\(\\geq 18\\) ) or with exercise (PCWP \\(\\geq 25\\) ) or","confidence":1,"confidence_rate":1},{"cnt":[[432,1177],[1472,1177],[1472,1227],[432,1227]],"region":{"top_left_x":431,"top_left_y":1177,"width":1041,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dce1fe57a2c945f1922783fa8661bbe1","type":"text","conversion_output":true,"text":"- Elevated NT-proBNP ( \\(>400 pg / ml\\) ) or BNP( \\(>200 pg / ml\\) ) or","text_display":"\n- Elevated NT-proBNP ( \\(>400 pg / ml\\) ) or BNP( \\(>200 pg / ml\\) ) or","confidence":0.9965834617614746,"confidence_rate":0.9999572210658835},{"cnt":[[432,1229],[1764,1229],[1764,1283],[432,1283]],"region":{"top_left_x":431,"top_left_y":1228,"width":1333,"height":55},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9c99f75fbe8f4c55b87c9e4b22693dcc","type":"text","conversion_output":true,"text":"- Echo evidence of diastolic dysfunction/elevated filling pressures manifest by","text_display":"\n- Echo evidence of diastolic dysfunction/elevated filling pressures manifest by","confidence":1,"confidence_rate":1},{"cnt":[[494,1280],[1807,1280],[1807,1330],[494,1330]],"region":{"top_left_x":494,"top_left_y":1280,"width":1313,"height":50},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"51751572f4254e3fa356210fb3ce4a2d","type":"text","conversion_output":true,"text":"medial \\(E / e ^{\\prime}\\) ratio \\(\\geq 15\\) and/or left atrial enlargement and chronic treatment with a","text_display":" medial \\(E / e ^{\\prime}\\) ratio \\(\\geq 15\\) and/or left atrial enlargement and chronic treatment with a","confidence":0.9179308805291839,"confidence_rate":0.9991847783335308},{"cnt":[[494,1332],[1334,1332],[1334,1381],[494,1381]],"region":{"top_left_x":494,"top_left_y":1332,"width":841,"height":50},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eb97fd33ea884f55a5d868f04a50c307","type":"text","conversion_output":true,"text":"loop diuretic for signs or symptoms of heart failure","text_display":" loop diuretic for signs or symptoms of heart failure","confidence":1,"confidence_rate":1},{"cnt":[[322,1381],[1734,1381],[1734,1433],[322,1433]],"region":{"top_left_x":322,"top_left_y":1381,"width":1412,"height":53},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"958535d1c9de457eab88dfdfc8a4b8b1","type":"text","conversion_output":true,"text":"5. 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Peak \\(VO _{2} \\leq 75 \\%\\) predicted with peak respiratory exchange ratio \\(\\geq 1.0 CPET\\)","confidence":0.754514217376709,"confidence_rate":0.9969093884677945},{"cnt":[[642,1835],[1485,1835],[1485,2473],[642,2473]],"region":{"top_left_x":642,"top_left_y":1834,"width":843,"height":639},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6aab3f81464e4fdabeee14b31f738d7a","type":"table","conversion_output":true,"text":"\\begin{tabular}{|l|c|c|}\n\\hline & \\begin{tabular}{c} \nNormal \\\\\nValues for \\\\\nPeak VO \\(_{2}{ }^{*}\\)\n\\end{tabular} & \\begin{tabular}{c} \nCriteria (ml/kg/min) \\\\\n\\(<75 \\%\\) Normal \\\\\nValue\n\\end{tabular} \\\\\n\\hline \\(20-29 M\\) & \\(43 \\pm 7.2\\) & \\(<32.3\\) \\\\\n\\hline \\(20-29 F\\) & \\(36 \\pm 6.9\\) & \\(<27.0\\) \\\\\n\\hline \\(30-39 M\\) & \\(42 \\pm 7.0\\) & \\(<31.5\\) \\\\\n\\hline \\(30-39 F\\) & \\(34 \\pm 6.2\\) & \\(<25.5\\) \\\\\n\\hline \\(40-49 M\\) & \\(40 \\pm 7.2\\) & \\(<30.0\\) \\\\\n\\hline \\(40-49 F\\) & \\(32 \\pm 6.2\\) & \\(<24.0\\) \\\\\n\\hline \\(50-59 M\\) & \\(36 \\pm 7.1\\) & \\(<27.0\\) \\\\\n\\hline \\(50-59 F\\) & \\(29 \\pm 5.4\\) & \\(<21.8\\) \\\\\n\\hline \\(60-69 M\\) & \\(33 \\pm 7.3\\) & \\(<24.8\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|c|c|}\n\\hline & \\begin{tabular}{c} \nNormal \\\\\nValues for \\\\\nPeak VO \\(_{2}{ }^{*}\\)\n\\end{tabular} & \\begin{tabular}{c} \nCriteria (ml/kg/min) \\\\\n\\(<75 \\%\\) Normal \\\\\nValue\n\\end{tabular} \\\\\n\\hline \\(20-29 M\\) & \\(43 \\pm 7.2\\) & \\(<32.3\\) \\\\\n\\hline \\(20-29 F\\) & \\(36 \\pm 6.9\\) & \\(<27.0\\) \\\\\n\\hline \\(30-39 M\\) & \\(42 \\pm 7.0\\) & \\(<31.5\\) \\\\\n\\hline \\(30-39 F\\) & \\(34 \\pm 6.2\\) & \\(<25.5\\) \\\\\n\\hline \\(40-49 M\\) & \\(40 \\pm 7.2\\) & \\(<30.0\\) \\\\\n\\hline \\(40-49 F\\) & \\(32 \\pm 6.2\\) & \\(<24.0\\) \\\\\n\\hline \\(50-59 M\\) & \\(36 \\pm 7.1\\) & \\(<27.0\\) \\\\\n\\hline \\(50-59 F\\) & \\(29 \\pm 5.4\\) & \\(<21.8\\) \\\\\n\\hline \\(60-69 M\\) & \\(33 \\pm 7.3\\) & \\(<24.8\\) \\\\\n\\hline\n\\end{tabular}","confidence":0.47597119343563565,"confidence_rate":0.9982505934501003},{"cnt":[[245,2535],[849,2535],[849,2574],[245,2574]],"region":{"top_left_x":244,"top_left_y":2535,"width":605,"height":39},"line":33,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"e72ad2dfdabd434fba2f47162b087b22","type":"page_info","conversion_output":false,"text":"INDIE-HFpEF Protocol v1.3, 22April2016 (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1818,2535],[1863,2535],[1863,2570],[1818,2570]],"region":{"top_left_x":1817,"top_left_y":2535,"width":46,"height":35},"line":34,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"7409b1b29abf4ef8933d01b8b3c4b9d7","type":"page_info","conversion_output":false,"text":"23","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"2797815c-2843-46aa-81fc-4fe2b5548cd2-24","page":24,"lines":[{"cnt":[[640,196],[1480,196],[1480,363],[640,363]],"region":{"top_left_x":640,"top_left_y":195,"width":841,"height":169},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"314e2538348641dd9bceaf5c853ce09b","type":"table","conversion_output":true,"text":"\\begin{tabular}{|l|l|l|}\n\\hline \\(60-69 F\\) & \\(27 \\pm 4.7\\) & \\(<20.3\\) \\\\\n\\hline\\(>70 M\\) & \\(29 \\pm 7.3\\) & \\(<21.8\\) \\\\\n\\hline\\(>70 F\\) & \\(27 \\pm 5.8\\) & \\(<20.3\\) \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{tabular}{|l|l|l|}\n\\hline \\(60-69 F\\) & \\(27 \\pm 4.7\\) & \\(<20.3\\) \\\\\n\\hline\\(>70 M\\) & \\(29 \\pm 7.3\\) & \\(<21.8\\) \\\\\n\\hline\\(>70 F\\) & \\(27 \\pm 5.8\\) & \\(<20.3\\) \\\\\n\\hline\n\\end{tabular}","confidence":0.9585161209106445,"confidence_rate":0.9995764007660689},{"cnt":[[492,404],[1321,404],[1321,458],[492,458]],"region":{"top_left_x":491,"top_left_y":403,"width":831,"height":55},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a56a2716054e479ca267a015e82c6d9f","type":"text","conversion_output":true,"text":"*Fletcher GF et al. Circulation. 1995; 91:580-615.","text_display":"\n*Fletcher GF et al. Circulation. 1995; 91:580-615.","confidence":0.9956090442137793,"confidence_rate":0.9999199918490815},{"cnt":[[305,509],[1878,509],[1878,561],[305,561]],"region":{"top_left_x":305,"top_left_y":509,"width":1573,"height":52},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aee0546372794db58bc4db573e02d024","type":"text","conversion_output":true,"text":"7. No chronic nitrate therapy or not using intermittent sublingual nitroglycerin (requirement for","text_display":"\n7. No chronic nitrate therapy or not using intermittent sublingual nitroglycerin (requirement for","confidence":1,"confidence_rate":1},{"cnt":[[370,561],[1205,561],[1205,608],[370,608]],"region":{"top_left_x":369,"top_left_y":560,"width":837,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ceb2e7b7b0784fcca70c4e17f57094c7","type":"text","conversion_output":true,"text":"\\(>1\\) SL nitroglycerin per week) within last 6 months","text_display":" \\(>1\\) SL nitroglycerin per week) within last 6 months","confidence":0.7216796875,"confidence_rate":0.9942939925993136},{"cnt":[[305,610],[1843,610],[1843,660],[305,660]],"region":{"top_left_x":305,"top_left_y":610,"width":1539,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"622dd8ec8aa54371a8f2950ba001d018","type":"text","conversion_output":true,"text":"8. No daily use of phosphodiesterase 5 inhibitors or soluble guanylyl cyclase activators and","text_display":"\n8. No daily use of phosphodiesterase 5 inhibitors or soluble guanylyl cyclase activators and","confidence":1,"confidence_rate":1},{"cnt":[[370,662],[1706,662],[1706,711],[370,711]],"region":{"top_left_x":369,"top_left_y":661,"width":1337,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d5d0cf1024414e229cac8ac500560c11","type":"text","conversion_output":true,"text":"willing to withhold prn use of phosphodiesterase 5 inhibitors for duration of study","text_display":" willing to withhold prn use of phosphodiesterase 5 inhibitors for duration of study","confidence":1,"confidence_rate":1},{"cnt":[[305,713],[1188,713],[1188,763],[305,763]],"region":{"top_left_x":305,"top_left_y":713,"width":884,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"83a214d1eda544abb5d4233538c04390","type":"text","conversion_output":true,"text":"9. Ambulatory (not wheelchair / scooter dependent)","text_display":"\n9. Ambulatory (not wheelchair / scooter dependent)","confidence":0.99853515625,"confidence_rate":0.9999733473064166},{"cnt":[[296,763],[1846,763],[1846,810],[296,810]],"region":{"top_left_x":296,"top_left_y":762,"width":1550,"height":48},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f99fcecdd47d4c36a9ab88f535f435a3","type":"text","conversion_output":true,"text":"10. Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably","text_display":"\n10. Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably","confidence":1,"confidence_rate":1},{"cnt":[[370,812],[1815,812],[1815,862],[370,862]],"region":{"top_left_x":369,"top_left_y":812,"width":1447,"height":50},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"893b6875bb4e44e0818a64a17f027611","type":"text","conversion_output":true,"text":"fasten the test belt provided for the screening process (belt designed to fit persons with","text_display":" fasten the test belt provided for the screening process (belt designed to fit persons with","confidence":1,"confidence_rate":1},{"cnt":[[370,864],[1476,864],[1476,913],[370,913]],"region":{"top_left_x":369,"top_left_y":863,"width":1107,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"08e7a760e999497ab6796f17df4e9395","type":"text","conversion_output":true,"text":"BMI \\(20-40 kg / m ^{2}\\) but belt may fit some persons outside this range)","text_display":" BMI \\(20-40 kg / m ^{2}\\) but belt may fit some persons outside this range)","confidence":0.9990234375,"confidence_rate":0.9999885054819704},{"cnt":[[294,915],[1519,915],[1519,965],[294,965]],"region":{"top_left_x":294,"top_left_y":915,"width":1225,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6f9f235960d14185ab63e0b99040a8c4","type":"text","conversion_output":true,"text":"11. Willingness to wear the accelerometer belt for the duration of the trial","text_display":"\n11. Willingness to wear the accelerometer belt for the duration of the trial","confidence":0.99951171875,"confidence_rate":0.9999939703823991},{"cnt":[[294,965],[1042,965],[1042,1016],[294,1016]],"region":{"top_left_x":294,"top_left_y":964,"width":748,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"480a688ff9cf4c58a164d94489b39923","type":"text","conversion_output":true,"text":"12. Willingness to provide informed consent","text_display":"\n12. Willingness to provide informed consent","confidence":1,"confidence_rate":1},{"cnt":[[245,1070],[681,1070],[681,1115],[245,1115]],"region":{"top_left_x":244,"top_left_y":1069,"width":438,"height":47},"line":13,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"78a8011cd40e469da4c8be2baa48841d","type":"section_header","conversion_output":true,"text":"9.3 Exclusion Criteria","text_display":"\n\n\\subsection*{9.3 Exclusion Criteria}","confidence":0.99755859375,"confidence_rate":0.9999094710853311},{"cnt":[[305,1143],[1210,1143],[1210,1190],[305,1190]],"region":{"top_left_x":305,"top_left_y":1142,"width":905,"height":49},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f33963b968874e29aca6e0c10afb1c92","type":"text","conversion_output":true,"text":"1. Recent (< 1 month) hospitalization for heart failure","text_display":"\n1. Recent (< 1 month) hospitalization for heart failure","confidence":0.9689919948577881,"confidence_rate":0.9995001419807273},{"cnt":[[305,1192],[1747,1192],[1747,1240],[305,1240]],"region":{"top_left_x":305,"top_left_y":1192,"width":1442,"height":48},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ac1798e069c7442da7c05092386310c4","type":"text","conversion_output":true,"text":"2. Ongoing requirement for PDE5 inhibitor, organic nitrate or soluble guanylyl cyclase","text_display":"\n2. Ongoing requirement for PDE5 inhibitor, organic nitrate or soluble guanylyl cyclase","confidence":1,"confidence_rate":1},{"cnt":[[370,1246],[539,1246],[539,1287],[370,1287]],"region":{"top_left_x":369,"top_left_y":1246,"width":171,"height":41},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"01937e49de7a45b89dcd7dc1b52f3124","type":"text","conversion_output":true,"text":"activators","text_display":" activators","confidence":1,"confidence_rate":1},{"cnt":[[305,1293],[1467,1293],[1467,1343],[305,1343]],"region":{"top_left_x":305,"top_left_y":1293,"width":1163,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"645edaad5e264ae09f9972be93bc4b3d","type":"text","conversion_output":true,"text":"3. Hemoglobin \\(( Hgb )<8.0 g / dl\\) within 30 days prior to randomization","text_display":"\n3. Hemoglobin \\(( Hgb )<8.0 g / dl\\) within 30 days prior to randomization","confidence":0.6170411895175221,"confidence_rate":0.9943358725941445},{"cnt":[[305,1343],[1420,1343],[1420,1394],[305,1394]],"region":{"top_left_x":305,"top_left_y":1342,"width":1116,"height":53},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7bd1d64de42e42a1a08ce9d80154b355","type":"text","conversion_output":true,"text":"4. \\(GFR <20 ml / min / 1.73 m^{2}\\) within 30 days prior to randomization","text_display":"\n4. \\(GFR <20 ml / min / 1.73 m^{2}\\) within 30 days prior to randomization","confidence":0.99951171875,"confidence_rate":0.9999945733425232},{"cnt":[[305,1394],[1876,1394],[1876,1446],[305,1446]],"region":{"top_left_x":305,"top_left_y":1394,"width":1571,"height":52},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e7cd84fa7fd54713ade6764dbb98957f","type":"text","conversion_output":true,"text":"5. Systolic blood pressure \\(<115 mmHg\\) seated or \\(<90 mmHg\\) standing just prior to test dose","text_display":"\n5. Systolic blood pressure \\(<115 mmHg\\) seated or \\(<90 mmHg\\) standing just prior to test dose","confidence":0.9990236759185791,"confidence_rate":0.9999905165401506},{"cnt":[[305,1446],[1033,1446],[1033,1493],[305,1493]],"region":{"top_left_x":305,"top_left_y":1445,"width":729,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d7dc65512f44791ba7bbd46b46613dc","type":"text","conversion_output":true,"text":"6. Resting HR \\(>110\\) just prior to test dose","text_display":"\n6. Resting HR \\(>110\\) just prior to test dose","confidence":0.9791007041931152,"confidence_rate":0.9995776736569375},{"cnt":[[305,1495],[1794,1495],[1794,1545],[305,1545]],"region":{"top_left_x":305,"top_left_y":1495,"width":1489,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"34d10a358d14443f93063c2b3e6a858d","type":"text","conversion_output":true,"text":"7. Previous adverse reaction to the study drug which necessitated withdrawal of therapy","text_display":"\n7. Previous adverse reaction to the study drug which necessitated withdrawal of therapy","confidence":1,"confidence_rate":1},{"cnt":[[305,1547],[1742,1547],[1742,1596],[305,1596]],"region":{"top_left_x":305,"top_left_y":1546,"width":1438,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"883b4befff6c4e1ea15f629fb0736a2c","type":"text","conversion_output":true,"text":"8. Significant chronic obstructive pulmonary disease thought to contribute to dyspnea","text_display":"\n8. Significant chronic obstructive pulmonary disease thought to contribute to dyspnea","confidence":1,"confidence_rate":1},{"cnt":[[305,1598],[1072,1598],[1072,1646],[305,1646]],"region":{"top_left_x":305,"top_left_y":1598,"width":768,"height":48},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"25e9e6570f41452c810d9eb6cb640d89","type":"text","conversion_output":true,"text":"9. Ischemia thought to contribute to dyspnea","text_display":"\n9. Ischemia thought to contribute to dyspnea","confidence":1,"confidence_rate":1},{"cnt":[[296,1646],[1001,1646],[1001,1695],[296,1695]],"region":{"top_left_x":296,"top_left_y":1645,"width":706,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41782af1e2db458fb2fbafce93c5bb40","type":"text","conversion_output":true,"text":"10. Documentation of previous \\(EF <45 \\%\\)","text_display":"\n10. Documentation of previous \\(EF <45 \\%\\)","confidence":0.6713786947075278,"confidence_rate":0.99077716741998},{"cnt":[[294,1697],[1876,1697],[1876,1747],[294,1747]],"region":{"top_left_x":294,"top_left_y":1697,"width":1582,"height":50},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e8ecc2c9adb349f1983f0178f9cb2bcc","type":"text","conversion_output":true,"text":"11. Acute coronary syndrome within 3 months defined by electrocardiographic (ECG) changes","text_display":"\n11. Acute coronary syndrome within 3 months defined by electrocardiographic (ECG) changes","confidence":0.99560546875,"confidence_rate":0.9999545967463781},{"cnt":[[370,1749],[1807,1749],[1807,1798],[370,1798]],"region":{"top_left_x":369,"top_left_y":1748,"width":1438,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2a8ebb7e5b074b30be9986fa8bed62f9","type":"text","conversion_output":true,"text":"and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting","text_display":" and biomarkers of myocardial necrosis (e.g., troponin) in an appropriate clinical setting","confidence":0.99951171875,"confidence_rate":0.999994804263518},{"cnt":[[370,1800],[1033,1800],[1033,1850],[370,1850]],"region":{"top_left_x":369,"top_left_y":1800,"width":665,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57f9e69248ca4bc3bed9a9ec571fa7c6","type":"text","conversion_output":true,"text":"(chest discomfort or anginal equivalent)","text_display":" (chest discomfort or anginal equivalent)","confidence":1,"confidence_rate":1},{"cnt":[[294,1850],[1796,1850],[1796,1897],[294,1897]],"region":{"top_left_x":294,"top_left_y":1849,"width":1503,"height":49},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"577d0b911e9b4f738255c90574fef997","type":"text","conversion_output":true,"text":"12. PCI, coronary artery bypass grafting, or new biventricular pacing within past 3 months","text_display":"\n12. PCI, coronary artery bypass grafting, or new biventricular pacing within past 3 months","confidence":0.8697710037231445,"confidence_rate":0.9985772853042699},{"cnt":[[296,1899],[1001,1899],[1001,1949],[296,1949]],"region":{"top_left_x":296,"top_left_y":1899,"width":706,"height":50},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3254d471763942af9d6fe5f28e8894b4","type":"text","conversion_output":true,"text":"13. Primary hypertrophic cardiomyopathy","text_display":"\n13. Primary hypertrophic cardiomyopathy","confidence":1,"confidence_rate":1},{"cnt":[[296,1951],[978,1951],[978,2000],[296,2000]],"region":{"top_left_x":296,"top_left_y":1950,"width":682,"height":51},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b6487370e2c4af0b61dc9dc3fedeb1c","type":"text","conversion_output":true,"text":"14. Infiltrative cardiomyopathy (amyloid)","text_display":"\n14. Infiltrative cardiomyopathy (amyloid)","confidence":1,"confidence_rate":1},{"cnt":[[296,2002],[1008,2002],[1008,2047],[296,2047]],"region":{"top_left_x":296,"top_left_y":2002,"width":712,"height":46},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2c3a335263e84d9fbb1d5842c85a4831","type":"text","conversion_output":true,"text":"15. Constrictive pericarditis or tamponade","text_display":"\n15. Constrictive pericarditis or tamponade","confidence":1,"confidence_rate":1},{"cnt":[[296,2052],[681,2052],[681,2099],[296,2099]],"region":{"top_left_x":296,"top_left_y":2051,"width":386,"height":49},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"136cd16039014fe3934cf8c3cd5327f8","type":"text","conversion_output":true,"text":"16. Active myocarditis","text_display":"\n16. Active myocarditis","confidence":1,"confidence_rate":1},{"cnt":[[294,2101],[943,2101],[943,2151],[294,2151]],"region":{"top_left_x":294,"top_left_y":2101,"width":650,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8f30816de05c4225be9c78aad53027b4","type":"text","conversion_output":true,"text":"17. Complex congenital heart disease","text_display":"\n17. Complex congenital heart disease","confidence":1,"confidence_rate":1},{"cnt":[[296,2153],[920,2153],[920,2202],[296,2202]],"region":{"top_left_x":296,"top_left_y":2152,"width":624,"height":51},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ff31d46377b54a55b2ee9d0c4e33fa92","type":"text","conversion_output":true,"text":"18. Active collagen vascular disease","text_display":"\n18. 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Intrinsic (prolapse, rheumatic) valve disease with moderate to severe or severe mitral,","confidence":1,"confidence_rate":1},{"cnt":[[370,2305],[879,2305],[879,2353],[370,2353]],"region":{"top_left_x":369,"top_left_y":2305,"width":510,"height":48},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f83cb7e74580493e9801335019c06778","type":"text","conversion_output":true,"text":"tricuspid or aortic regurgitation","text_display":" tricuspid or aortic regurgitation","confidence":1,"confidence_rate":1},{"cnt":[[292,2355],[1609,2355],[1609,2404],[292,2404]],"region":{"top_left_x":292,"top_left_y":2354,"width":1318,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ada92213e588489fb971e4716818a44f","type":"text","conversion_output":true,"text":"21. Acute or chronic severe liver disease as evidenced by any of the following:","text_display":"\n21. 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The metered, PURPLE latch medication chamber administers the lower dose of","text_display":" the nebulizer. The metered, PURPLE latch medication chamber administers the lower dose of","confidence":1,"confidence_rate":1},{"cnt":[[245,1508],[1781,1508],[1781,1560],[245,1560]],"region":{"top_left_x":244,"top_left_y":1508,"width":1538,"height":52},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c69134bcdf55487d82c3cc59a218a97c","type":"text","conversion_output":true,"text":"46 mg . The WHITE latch medication chamber administers a full 80 mg dose of medication.","text_display":" 46 mg . 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Each Participant will be provided with a PURPLE and a WHITE study","text_display":" during the study protocol. 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The I-neb is a small, battery-powered,","text_display":" AAD nebulizer over 10-15 minutes for each dose. The I-neb is a small, battery-powered,","confidence":0.6751213073730469,"confidence_rate":0.9956921309908784},{"cnt":[[245,1861],[1837,1861],[1837,1914],[245,1914]],"region":{"top_left_x":244,"top_left_y":1860,"width":1593,"height":55},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"caf0f4a44e484e5f93cb0129e194c5ac","type":"text","conversion_output":true,"text":"lightweight, and virtually silent drug delivery device designed to deliver a precise, reproducible","text_display":" lightweight, and virtually silent drug delivery device designed to deliver a precise, reproducible","confidence":1,"confidence_rate":1},{"cnt":[[245,1912],[1828,1912],[1828,1964],[245,1964]],"region":{"top_left_x":244,"top_left_y":1912,"width":1585,"height":52},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8e9db20f022437d9e06b9746f1dec58","type":"text","conversion_output":true,"text":"dose of drug. (Figure 7) Throughout the treatment, the I-neb provides continuous feedback to","text_display":" dose of drug. (Figure 7) Throughout the treatment, the I-neb provides continuous feedback to","confidence":0.99951171875,"confidence_rate":0.9999949649559944},{"cnt":[[245,1964],[1820,1964],[1820,2013],[245,2013]],"region":{"top_left_x":244,"top_left_y":1963,"width":1576,"height":51},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"eee44b53ab384dfda6cb46ddf3641615","type":"text","conversion_output":true,"text":"the Participant through a liquid crystal display, and upon successful delivery of the treatment,","text_display":" the Participant through a liquid crystal display, and upon successful delivery of the treatment,","confidence":1,"confidence_rate":1},{"cnt":[[245,2015],[1145,2015],[1145,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2015,"width":902,"height":50},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6926556bcdc34088b1dd7047cff436c2","type":"text","conversion_output":true,"text":"the Participant receives audible and tactile feedback.","text_display":" the Participant receives audible and tactile feedback.","confidence":1,"confidence_rate":1},{"cnt":[[245,2116],[1714,2116],[1714,2168],[245,2168]],"region":{"top_left_x":244,"top_left_y":2116,"width":1471,"height":52},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e632890483884f059bedf5b8a7f36018","type":"text","conversion_output":true,"text":"The device has a Participant logging system that automatically records adherence and","text_display":"\n\nThe device has a Participant logging system that automatically records adherence and","confidence":1,"confidence_rate":1},{"cnt":[[245,2166],[1850,2166],[1850,2215],[245,2215]],"region":{"top_left_x":244,"top_left_y":2165,"width":1606,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"00d3b9bc206d4bec997c30a3147368ad","type":"text","conversion_output":true,"text":"compliance with protocol-specified treatments. The device log will be reviewed by the research","text_display":" compliance with protocol-specified treatments. The device log will be reviewed by the research","confidence":1,"confidence_rate":1},{"cnt":[[245,2217],[1369,2217],[1369,2267],[245,2267]],"region":{"top_left_x":244,"top_left_y":2217,"width":1125,"height":50},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"48f6b2caac754550b9a9d531cda7544d","type":"text","conversion_output":true,"text":"coordinator with study participants verbally to optimize adherence.","text_display":" coordinator with study participants verbally to optimize adherence.","confidence":1,"confidence_rate":1},{"cnt":[[245,2320],[1835,2320],[1835,2368],[245,2368]],"region":{"top_left_x":244,"top_left_y":2320,"width":1591,"height":48},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5909f1c3bdf34d5e94aa77d4c9d72fc3","type":"text","conversion_output":true,"text":"The time to maximal concentration of \\(NO _{2}\\) in plasma is within 5 minutes, immediately after the","text_display":"\n\nThe time to maximal concentration of \\(NO _{2}\\) in plasma is within 5 minutes, immediately after the","confidence":1,"confidence_rate":1},{"cnt":[[245,2368],[1841,2368],[1841,2417],[245,2417]],"region":{"top_left_x":244,"top_left_y":2367,"width":1598,"height":50},"line":44,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ef60fedd7f2f453e8c472433807657aa","type":"text","conversion_output":true,"text":"end of the inhalation period ( \\(\\sim 15\\) minutes after start of inhalation). Maximal concentration after","text_display":" end of the inhalation period ( \\(\\sim 15\\) minutes after start of inhalation). Maximal concentration after","confidence":0.9965834617614746,"confidence_rate":0.999967713842597},{"cnt":[[245,2419],[1725,2419],[1725,2469],[245,2469]],"region":{"top_left_x":244,"top_left_y":2419,"width":1482,"height":50},"line":45,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1ac83697b18549cb9c11cb09469b2e93","type":"text","conversion_output":true,"text":"nebulization of an 80 mg dose is \\(10-12 micromol / L\\), which is \\(2-3\\)-fold higher than what is","text_display":" nebulization of an 80 mg dose is \\(10-12 micromol / L\\), which is \\(2-3\\)-fold higher than what is","confidence":0.7765064972245005,"confidence_rate":0.9977237633114849},{"cnt":[[245,2535],[844,2535],[844,2576],[245,2576]],"region":{"top_left_x":244,"top_left_y":2535,"width":601,"height":41},"line":46,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d2a561068fe14adfa457b3c498997931","type":"page_info","conversion_output":false,"text":"INDIE-HFpEF Protocol v1.3, 22April2016 (Final)","text_display":"","confidence":0.9970703125,"confidence_rate":0.9999424724893827},{"cnt":[[1818,2537],[1861,2537],[1861,2570],[1818,2570]],"region":{"top_left_x":1817,"top_left_y":2537,"width":44,"height":33},"line":47,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"5b8ee2cba4d34a66b714cd8e7b025607","type":"page_info","conversion_output":false,"text":"25","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"2797815c-2843-46aa-81fc-4fe2b5548cd2-26","page":26,"lines":[{"cnt":[[245,198],[1783,198],[1783,249],[245,249]],"region":{"top_left_x":244,"top_left_y":197,"width":1540,"height":53},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"df7eb416a51e4f4aa8b098c0ec003d9d","type":"text","conversion_output":true,"text":"achieved with oral \\(NO _{2}\\) administration (PK data on file). The mean (SD) terminal half-life of","text_display":"\nachieved with oral \\(NO _{2}\\) administration (PK data on file). The mean (SD) terminal half-life of","confidence":1,"confidence_rate":1},{"cnt":[[245,247],[1210,247],[1210,299],[245,299]],"region":{"top_left_x":244,"top_left_y":247,"width":966,"height":52},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcaa818a3eff48deb187533503cd6845","type":"text","conversion_output":true,"text":"nitrite in plasma in phase 1 testing was \\(0.6(0.2)\\) hours. \\({ }^{46}\\)","text_display":" nitrite in plasma in phase 1 testing was \\(0.6(0.2)\\) hours. \\({ }^{46}\\)","confidence":0.960486888885498,"confidence_rate":0.9994696808377829},{"cnt":[[245,352],[1858,352],[1858,402],[245,402]],"region":{"top_left_x":244,"top_left_y":352,"width":1615,"height":50},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7b85dbcc4d254518b823d8b642638855","type":"text","conversion_output":true,"text":"Permitted dose adjustment: If significant headache occurs, participants will be encouraged to","text_display":"\n\nPermitted dose adjustment: If significant headache occurs, participants will be encouraged to","confidence":1,"confidence_rate":1},{"cnt":[[245,404],[1833,404],[1833,451],[245,451]],"region":{"top_left_x":244,"top_left_y":403,"width":1589,"height":49},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57f4f26b55a2411390ad197f20806728","type":"text","conversion_output":true,"text":"treat headaches with acetaminophen. If participants cannot tolerate the 46 mg dose, they will","text_display":" treat headaches with acetaminophen. If participants cannot tolerate the 46 mg dose, they will","confidence":1,"confidence_rate":1},{"cnt":[[245,451],[1835,451],[1835,501],[245,501]],"region":{"top_left_x":244,"top_left_y":451,"width":1591,"height":50},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46e6068c298b4ba48243dd5e1ad7c9f1","type":"text","conversion_output":true,"text":"discontinue study drug but continue with all study procedures and visits. If Participants cannot","text_display":" discontinue study drug but continue with all study procedures and visits. If Participants cannot","confidence":1,"confidence_rate":1},{"cnt":[[245,503],[1858,503],[1858,552],[245,552]],"region":{"top_left_x":244,"top_left_y":502,"width":1615,"height":51},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"765a7152648b42aea43c81b9dc8e576d","type":"text","conversion_output":true,"text":"tolerate the 80 mg dose, they will return to the previously tolerated 46 mg dose and continue all","text_display":" tolerate the 80 mg dose, they will return to the previously tolerated 46 mg dose and continue all","confidence":1,"confidence_rate":1},{"cnt":[[245,554],[1747,554],[1747,604],[245,604]],"region":{"top_left_x":244,"top_left_y":554,"width":1503,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"41a4225d50bd4492bdea4211f7f3949d","type":"text","conversion_output":true,"text":"study procedures and visits. If a dose is missed, the 4 hour minimum regimen should be","text_display":" study procedures and visits. If a dose is missed, the 4 hour minimum regimen should be","confidence":1,"confidence_rate":1},{"cnt":[[245,606],[1858,606],[1858,651],[245,651]],"region":{"top_left_x":244,"top_left_y":605,"width":1615,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"29b6dd4470f547cc9f803fa872c097f3","type":"text","conversion_output":true,"text":"resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should","text_display":" resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should","confidence":1,"confidence_rate":1},{"cnt":[[245,655],[1016,655],[1016,703],[245,703]],"region":{"top_left_x":244,"top_left_y":655,"width":773,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"03a67dd2e6ae4b888513218c7647fa0e","type":"text","conversion_output":true,"text":"not be taken to make up for the missed dose.","text_display":" not be taken to make up for the missed dose.","confidence":1,"confidence_rate":1},{"cnt":[[245,756],[1876,756],[1876,804],[245,804]],"region":{"top_left_x":244,"top_left_y":756,"width":1632,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e2d93ddd595743c186ab07f36aab56b0","type":"text","conversion_output":true,"text":"If a participant has a temporary discontinuation for reasons other than intolerance, (e.g., such as","text_display":"\n\nIf a participant has a temporary discontinuation for reasons other than intolerance, (e.g., such as","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,804],[1871,804],[1871,853],[245,853]],"region":{"top_left_x":244,"top_left_y":803,"width":1628,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2b1d3c463a474d4a911fd512d1ca526c","type":"text","conversion_output":true,"text":"hospitalization, lost device, etc), the investigator can restart at the last tolerated dose. If the last","text_display":" hospitalization, lost device, etc), the investigator can restart at the last tolerated dose. If the last","confidence":1,"confidence_rate":1},{"cnt":[[245,855],[1807,855],[1807,904],[245,904]],"region":{"top_left_x":244,"top_left_y":855,"width":1563,"height":50},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8feadf9a87594a42b1ceeb1cb46d6913","type":"text","conversion_output":true,"text":"tolerated dose was 80 mg , and depending on duration of interruption as well as any potential","text_display":" tolerated dose was 80 mg , and depending on duration of interruption as well as any potential","confidence":1,"confidence_rate":1},{"cnt":[[245,907],[1848,907],[1848,956],[245,956]],"region":{"top_left_x":244,"top_left_y":906,"width":1604,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d221b5920cd4de482b3e2bbe84b371c","type":"text","conversion_output":true,"text":"safety concerns, the Investigator will have the flexibility to restart at the reduced dose of 46 mg","text_display":" safety concerns, the Investigator will have the flexibility to restart at the reduced dose of 46 mg","confidence":0.99853515625,"confidence_rate":0.9999860389766703},{"cnt":[[245,958],[1798,958],[1798,1008],[245,1008]],"region":{"top_left_x":244,"top_left_y":958,"width":1555,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dc311004737b430cbe2c4cf42be2ed16","type":"text","conversion_output":true,"text":"and up titrate to the 80 mg at their discretion. However, participants that down titrate due to","text_display":" and up titrate to the 80 mg at their discretion. However, participants that down titrate due to","confidence":1,"confidence_rate":1},{"cnt":[[245,1008],[1229,1008],[1229,1057],[245,1057]],"region":{"top_left_x":244,"top_left_y":1007,"width":985,"height":51},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"89154082f5494b44bdac4b4f8f1e006a","type":"text","conversion_output":true,"text":"intolerance should not be reintroduced to the higher dose.","text_display":" intolerance should not be reintroduced to the higher dose.","confidence":0.9970703125,"confidence_rate":0.9999534298552992},{"cnt":[[245,1109],[1871,1109],[1871,1158],[245,1158]],"region":{"top_left_x":244,"top_left_y":1108,"width":1628,"height":51},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e6de42d4465b448bb2173e5d4870d2e9","type":"text","conversion_output":true,"text":"Drug interactions: Potential excess nitric oxide mediated effects (e.g., hypotension, headache)","text_display":"\n\nDrug interactions: Potential excess nitric oxide mediated effects (e.g., hypotension, headache)","confidence":1,"confidence_rate":1},{"cnt":[[245,1160],[1837,1160],[1837,1210],[245,1210]],"region":{"top_left_x":244,"top_left_y":1160,"width":1593,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ea04d5518c1c4081847105ebaf3d216b","type":"text","conversion_output":true,"text":"might be observed with co-administration of organic nitrates or phosphodiesterase- 5 inhibitors","text_display":" might be observed with co-administration of organic nitrates or phosphodiesterase- 5 inhibitors","confidence":0.9956088066101074,"confidence_rate":0.9999572740875605},{"cnt":[[245,1212],[1644,1212],[1644,1261],[245,1261]],"region":{"top_left_x":244,"top_left_y":1211,"width":1400,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cdfd7477b8a148aa927da517082f2b69","type":"text","conversion_output":true,"text":"or soluble guanylyl cyclase activators. Therefore, co-administration of nitrates, any","text_display":" or soluble guanylyl cyclase activators. Therefore, co-administration of nitrates, any","confidence":1,"confidence_rate":1},{"cnt":[[245,1263],[1749,1261],[1749,1310],[245,1313]],"region":{"top_left_x":244,"top_left_y":1260,"width":1505,"height":53},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d620f26e791943e380445e803faa8bf6","type":"text","conversion_output":true,"text":"phosphodiesterase-5 inhibitor formulation or soluble guanylyl cyclase activators is strictly","text_display":" phosphodiesterase-5 inhibitor formulation or soluble guanylyl cyclase activators is strictly","confidence":1,"confidence_rate":1},{"cnt":[[245,1311],[1858,1311],[1858,1360],[245,1360]],"region":{"top_left_x":244,"top_left_y":1310,"width":1615,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c21dc3ff6c84a26ad7a45be31533f0b","type":"text","conversion_output":true,"text":"contraindicated due to the risk of hypotension. There are no other known drug interactions and","text_display":" contraindicated due to the risk of hypotension. There are no other known drug interactions and","confidence":1,"confidence_rate":1},{"cnt":[[245,1362],[1876,1362],[1876,1412],[245,1412]],"region":{"top_left_x":244,"top_left_y":1362,"width":1632,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dbc3691c9a8e4ee78dae9fa19e7f96c0","type":"text","conversion_output":true,"text":"study drug absorption is not affected by food or administration of other inhalers (inhaled steroids","text_display":" study drug absorption is not affected by food or administration of other inhalers (inhaled steroids","confidence":1,"confidence_rate":1},{"cnt":[[245,1414],[582,1414],[582,1463],[245,1463]],"region":{"top_left_x":244,"top_left_y":1413,"width":339,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b2e6a35db52246c69415370a597a8a8d","type":"text","conversion_output":true,"text":"or bronchodilators).","text_display":" or bronchodilators).","confidence":1,"confidence_rate":1},{"cnt":[[245,1515],[666,1515],[666,1571],[245,1571]],"region":{"top_left_x":244,"top_left_y":1514,"width":423,"height":57},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0ec72b0b19b140b9954dc73af9df8116","type":"section_header","conversion_output":false,"children_ids":["3d36ab25d6b94976a98d25f2eb3ec977"],"text":"","text_display":""},{"cnt":[[249,1519],[660,1519],[660,1566],[249,1566]],"region":{"top_left_x":249,"top_left_y":1518,"width":411,"height":49},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3d36ab25d6b94976a98d25f2eb3ec977","type":"text","conversion_output":true,"parent_id":"0ec72b0b19b140b9954dc73af9df8116","text":"10.2 Drug Dispensing","text_display":"\n\n\\subsection*{10.2 Drug Dispensing}","confidence":1,"confidence_rate":1},{"cnt":[[245,1590],[1727,1590],[1727,1639],[245,1639]],"region":{"top_left_x":244,"top_left_y":1589,"width":1484,"height":51},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"20fc1ce1b9ff4f12af2b271850e536b2","type":"text","conversion_output":true,"text":"Drug dispensing will be managed by the CC who will obtain and store supplies from the","text_display":"\n\nDrug dispensing will be managed by the CC who will obtain and store supplies from the","confidence":0.9907269477844238,"confidence_rate":0.9998964907505445},{"cnt":[[245,1641],[1867,1641],[1867,1691],[245,1691]],"region":{"top_left_x":244,"top_left_y":1641,"width":1623,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"939d4bde60fd43fca8dbea75c4e062a2","type":"text","conversion_output":true,"text":"contracted drug supply vendor. At the first study visit, participants will receive a sufficient supply","text_display":" contracted drug supply vendor. At the first study visit, participants will receive a sufficient supply","confidence":1,"confidence_rate":1},{"cnt":[[245,1691],[1837,1691],[1837,1738],[245,1738]],"region":{"top_left_x":244,"top_left_y":1690,"width":1593,"height":49},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dcccd19a52c7439bbda3db2b1130ff34","type":"text","conversion_output":true,"text":"of inorganic nitrite or placebo ampules to permit three doses a day until the second study visit,","text_display":" of inorganic nitrite or placebo ampules to permit three doses a day until the second study visit,","confidence":1,"confidence_rate":1},{"cnt":[[245,1740],[1699,1740],[1699,1790],[245,1790]],"region":{"top_left_x":244,"top_left_y":1740,"width":1456,"height":50},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7db29897885c42fda6cc298bf1467afe","type":"text","conversion_output":true,"text":"realizing that participants may not be able to return at the exact 42 day window due to","text_display":" realizing that participants may not be able to return at the exact 42 day window due to","confidence":1,"confidence_rate":1},{"cnt":[[245,1792],[1807,1792],[1807,1841],[245,1841]],"region":{"top_left_x":244,"top_left_y":1791,"width":1563,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a3508472e464cd9829ceb473c21a70c","type":"text","conversion_output":true,"text":"scheduling conflicts (range 42-49 days). To account for potential damage or loss of ampules","text_display":" scheduling conflicts (range 42-49 days). To account for potential damage or loss of ampules","confidence":0.96240234375,"confidence_rate":0.999600885094566},{"cnt":[[245,1843],[1779,1843],[1779,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1843,"width":1535,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0a08c51a67f142dd9e31aa83aba372e1","type":"text","conversion_output":true,"text":"after opening the pouches containing multiple ampules and to account for unavoidable (for","text_display":" after opening the pouches containing multiple ampules and to account for unavoidable (for","confidence":1,"confidence_rate":1},{"cnt":[[245,1893],[1846,1893],[1846,1940],[245,1940]],"region":{"top_left_x":244,"top_left_y":1892,"width":1602,"height":49},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f25b6e3872e4886b3f0ab53013f1459","type":"text","conversion_output":true,"text":"example adverse weather, family illness, etc) further delays in returning for study visits beyond","text_display":" example adverse weather, family illness, etc) further delays in returning for study visits beyond","confidence":1,"confidence_rate":1},{"cnt":[[245,1942],[1794,1942],[1794,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1942,"width":1550,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"abbbcb397c2e43a7b00e6b6e54852b93","type":"text","conversion_output":true,"text":"the 42 day ( + up to 7 days) timeline, additional study drug doses will be supplied). Similarly,","text_display":" the 42 day ( + up to 7 days) timeline, additional study drug doses will be supplied). 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Only approved study personnel will have","text_display":" procedures in place at each participating center. Only approved study personnel will have","confidence":1,"confidence_rate":1},{"cnt":[[245,2269],[1876,2269],[1876,2318],[245,2318]],"region":{"top_left_x":244,"top_left_y":2268,"width":1632,"height":51},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7e4a5ecd3cb4c18af3ab51c6fc0a8a1","type":"text","conversion_output":true,"text":"access to data collected as part of the study. Consented study participants will be identified by a","text_display":" access to data collected as part of the study. 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Data will be transmitted to the CC in a secure","confidence":1,"confidence_rate":1},{"cnt":[[245,2368],[1854,2368],[1854,2421],[245,2421]],"region":{"top_left_x":244,"top_left_y":2367,"width":1611,"height":55},"line":42,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53366cf8af9544fa8718a885a01f5dd1","type":"text","conversion_output":true,"text":"manner, and stored securely at the CC using standard Duke Clinical Research Institute (DCRI)","text_display":" manner, and stored securely at the CC using standard Duke Clinical Research Institute (DCRI)","confidence":1,"confidence_rate":1},{"cnt":[[245,2419],[625,2419],[625,2469],[245,2469]],"region":{"top_left_x":244,"top_left_y":2419,"width":382,"height":50},"line":43,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8c9ec46e00d54e5db020a03957bbf8fd","type":"text","conversion_output":true,"text":"operating procedures.","text_display":" operating 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regulations at 21 CFR parts 50, 56, and 312.","text_display":" Human Services (HHS) regulations at 21 CFR parts 50, 56, and 312.","confidence":0.9921875,"confidence_rate":0.999891072912694},{"cnt":[[241,408],[1027,408],[1027,468],[241,468]],"region":{"top_left_x":240,"top_left_y":408,"width":787,"height":61},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ec11fca06e164dd984a06403c84afc5d","type":"section_header","conversion_output":false,"children_ids":["aa2ddfe07de244bdb230e888181dc0b4"],"text":"","text_display":""},{"cnt":[[245,412],[1021,412],[1021,462],[245,462]],"region":{"top_left_x":244,"top_left_y":412,"width":777,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa2ddfe07de244bdb230e888181dc0b4","type":"text","conversion_output":true,"parent_id":"ec11fca06e164dd984a06403c84afc5d","text":"11.3.4 Summary of the Risks and Benefits","text_display":"\n\n\\subsection*{11.3.4 Summary of the Risks and 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Thus, during the phase when a participant receives active study drug (inorganic nitrite)","text_display":" HFpEF. Thus, during the phase when a participant receives active study drug (inorganic nitrite)","confidence":0.91357421875,"confidence_rate":0.9990965018016554},{"cnt":[[245,1899],[1420,1899],[1420,1949],[245,1949]],"region":{"top_left_x":244,"top_left_y":1899,"width":1177,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3f08907ffb940f5a952ef75d94fc65c","type":"text","conversion_output":true,"text":"rather than placebo, they could potentially experience clinical benefit.","text_display":" rather than placebo, they could potentially experience clinical benefit.","confidence":1,"confidence_rate":1},{"cnt":[[241,2007],[1502,2007],[1502,2069],[241,2069]],"region":{"top_left_x":240,"top_left_y":2006,"width":1262,"height":63},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2af361bfb7534813bc68cbe4456f77da","type":"section_header","conversion_output":false,"children_ids":["986ef13eeb5a40ae8d3b3fda5297a8a0"],"text":"","text_display":""},{"cnt":[[245,2015],[1497,2015],[1497,2065],[245,2065]],"region":{"top_left_x":244,"top_left_y":2015,"width":1254,"height":50},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"986ef13eeb5a40ae8d3b3fda5297a8a0","type":"text","conversion_output":true,"parent_id":"2af361bfb7534813bc68cbe4456f77da","text":"12 BASELINE EVALUATION AND RANDOMIZATION VISIT","text_display":"\n\n\\section*{12 BASELINE EVALUATION AND RANDOMIZATION VISIT}","confidence":0.99853515625,"confidence_rate":0.9999706820761288},{"cnt":[[245,2114],[1639,2114],[1639,2163],[245,2163]],"region":{"top_left_x":244,"top_left_y":2114,"width":1396,"height":50},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"95eb9761d90d4f8f946e66b13719caf0","type":"text","conversion_output":true,"text":"A complete schedule of assessments throughout the study is given in Appendix A.","text_display":"\n\nA complete schedule of assessments throughout the study is given in Appendix A.","confidence":0.94580078125,"confidence_rate":0.9993368470932397},{"cnt":[[243,2213],[548,2213],[548,2275],[243,2275]],"region":{"top_left_x":242,"top_left_y":2212,"width":306,"height":64},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e4cd0a2dc1214d0180e0dc1b41f80a01","type":"section_header","conversion_output":false,"children_ids":["3c5eb300e66242e99d755fb1a3c5589c"],"text":"","text_display":""},{"cnt":[[247,2219],[541,2219],[541,2271],[247,2271]],"region":{"top_left_x":247,"top_left_y":2219,"width":295,"height":52},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3c5eb300e66242e99d755fb1a3c5589c","type":"text","conversion_output":true,"parent_id":"e4cd0a2dc1214d0180e0dc1b41f80a01","text":"12.1 Screening","text_display":"\n\n\\subsection*{12.1 Screening}","confidence":1,"confidence_rate":1},{"cnt":[[245,2290],[1824,2290],[1824,2342],[245,2342]],"region":{"top_left_x":244,"top_left_y":2290,"width":1581,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d3dc4eaac26747c288027b27eaa41dad","type":"text","conversion_output":true,"text":"Patients will be screened for entry criteria at each site using existing clinical records including","text_display":"\n\nPatients will be screened for entry criteria at each site using existing clinical records including","confidence":1,"confidence_rate":1},{"cnt":[[245,2342],[1680,2342],[1680,2391],[245,2391]],"region":{"top_left_x":244,"top_left_y":2341,"width":1437,"height":51},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f4b783f482e4b0f9df46044d38d7e87","type":"text","conversion_output":true,"text":"their most recent echocardiogram (echo within 12 months) and blood work. Potential","text_display":" their most recent echocardiogram (echo within 12 months) and blood work. Potential","confidence":1,"confidence_rate":1},{"cnt":[[245,2391],[1040,2391],[1040,2443],[245,2443]],"region":{"top_left_x":244,"top_left_y":2391,"width":796,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d4f16bd2b1e84b9b9e9c6b26e35ed95c","type":"text","conversion_output":true,"text":"participants will be scheduled for Study Visit 1.","text_display":" participants will be scheduled for Study Visit 1.","confidence":1,"confidence_rate":1},{"cnt":[[245,2535],[846,2535],[846,2574],[245,2574]],"region":{"top_left_x":244,"top_left_y":2535,"width":603,"height":39},"line":39,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"535439c360d94051acb5bc8fd233b9f7","type":"page_info","conversion_output":false,"text":"INDIE-HFpEF Protocol v1.3, 22April2016 (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1818,2537],[1861,2537],[1861,2570],[1818,2570]],"region":{"top_left_x":1817,"top_left_y":2537,"width":44,"height":33},"line":40,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"329d32e7361540ec9ddd2045628fbc1e","type":"page_info","conversion_output":false,"text":"29","text_display":"","confidence":0.99951171875,"confidence_rate":0.9997558295653994}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"2797815c-2843-46aa-81fc-4fe2b5548cd2-30","page":30,"lines":[{"cnt":[[243,193],[1042,193],[1042,254],[243,254]],"region":{"top_left_x":242,"top_left_y":193,"width":800,"height":61},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"13afe834611544a6a048f65ece77ef2c","type":"section_header","conversion_output":false,"children_ids":["c25bed4d7258449e8cc206a6e6f621c7"],"text":"","text_display":""},{"cnt":[[247,198],[1038,198],[1038,247],[247,247]],"region":{"top_left_x":247,"top_left_y":197,"width":791,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c25bed4d7258449e8cc206a6e6f621c7","type":"text","conversion_output":true,"parent_id":"13afe834611544a6a048f65ece77ef2c","text":"12.2 Baseline/Randomization Visit (Visit 1)","text_display":"\n\n\\subsection*{12.2 Baseline/Randomization Visit (Visit 1)}","confidence":0.99951171875,"confidence_rate":0.999989825041388},{"cnt":[[245,271],[1850,271],[1850,320],[245,320]],"region":{"top_left_x":244,"top_left_y":270,"width":1606,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b6456ab9b9ac41b0a27ad2ca00e02962","type":"text","conversion_output":true,"text":"Patients who fulfill entry criteria will undergo the consent process and written informed consent","text_display":"\n\nPatients who fulfill entry criteria will undergo the consent process and written informed consent","confidence":1,"confidence_rate":1},{"cnt":[[245,322],[1858,322],[1858,372],[245,372]],"region":{"top_left_x":244,"top_left_y":322,"width":1615,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba3682d6bb174bd0ad6e72c8645ea621","type":"text","conversion_output":true,"text":"will be obtained prior to any study specific procedures. A screening question to assess whether","text_display":" will be obtained prior to any study specific procedures. A screening question to assess whether","confidence":1,"confidence_rate":1},{"cnt":[[245,370],[1854,370],[1854,421],[245,421]],"region":{"top_left_x":244,"top_left_y":369,"width":1611,"height":53},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b43329dee9db4846b448024a67f89b14","type":"text","conversion_output":true,"text":"their ability to be active is related to their heart failure symptoms (versus orthopedic, neurologic","text_display":" their ability to be active is related to their heart failure symptoms (versus orthopedic, neurologic","confidence":1,"confidence_rate":1},{"cnt":[[245,421],[1861,421],[1861,471],[245,471]],"region":{"top_left_x":244,"top_left_y":421,"width":1617,"height":50},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2f9c9a490b4346b193a4219d4fba0594","type":"text","conversion_output":true,"text":"or behavioral factors) will be completed. If patients indicate that reasons other than heart failure","text_display":" or behavioral factors) will be completed. If patients indicate that reasons other than heart failure","confidence":1,"confidence_rate":1},{"cnt":[[245,473],[1790,473],[1790,522],[245,522]],"region":{"top_left_x":244,"top_left_y":472,"width":1546,"height":51},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"70898a21ddd94c5e8c00aac7a5279bfa","type":"text","conversion_output":true,"text":"symptoms limit their ability to be active, they will be considered a screen failure and will not","text_display":" symptoms limit their ability to be active, they will be considered a screen failure and will not","confidence":1,"confidence_rate":1},{"cnt":[[245,524],[1807,524],[1807,574],[245,574]],"region":{"top_left_x":244,"top_left_y":524,"width":1563,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f4452e3ff5fa4dae83a5f8e0fcd4095d","type":"text","conversion_output":true,"text":"continue. Subjects will be assessed for their ability to wear the accelerometer belt confirmed","text_display":" continue. Subjects will be assessed for their ability to wear the accelerometer belt confirmed","confidence":1,"confidence_rate":1},{"cnt":[[245,574],[1790,574],[1790,625],[245,625]],"region":{"top_left_x":244,"top_left_y":573,"width":1546,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d53ac8e56df94e918d7913b40adc3c9f","type":"text","conversion_output":true,"text":"with a \"test belt\" provided to each center. Willingness to wear the accelerometer belt and to","text_display":" with a \"test belt\" provided to each center. Willingness to wear the accelerometer belt and to","confidence":1,"confidence_rate":1},{"cnt":[[245,623],[1051,623],[1051,675],[245,675]],"region":{"top_left_x":244,"top_left_y":623,"width":807,"height":52},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"efd7e098e5dc450bae18485783b99a4e","type":"text","conversion_output":true,"text":"participate in all study procedures is confirmed.","text_display":" participate in all study procedures is confirmed.","confidence":1,"confidence_rate":1},{"cnt":[[245,726],[1824,726],[1824,776],[245,776]],"region":{"top_left_x":244,"top_left_y":726,"width":1581,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d859fcdcc78c4e7d9fca39895c7f1445","type":"text","conversion_output":true,"text":"Once confirmed, the participant will undergo baseline blood draws, to include CBC, complete","text_display":"\n\nOnce confirmed, the participant will undergo baseline blood draws, to include CBC, complete","confidence":0.962890625,"confidence_rate":0.999606166624848},{"cnt":[[245,776],[1837,776],[1837,827],[245,827]],"region":{"top_left_x":244,"top_left_y":775,"width":1593,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5ce8dfa5892483d9f7da735e0670320","type":"text","conversion_output":true,"text":"chemistry panel, biomarkers, biorepository and genetics (if agreed to participate), and then an","text_display":" chemistry panel, biomarkers, biorepository and genetics (if agreed to participate), and then an","confidence":1,"confidence_rate":1},{"cnt":[[245,825],[1858,825],[1858,879],[245,879]],"region":{"top_left_x":244,"top_left_y":825,"width":1615,"height":54},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f8ddfb85cd2248fa85fe4a41e76f1a34","type":"text","conversion_output":true,"text":"HFN study-specific, baseline CPET will be conducted to ensure patient meets the entry criteria.","text_display":" HFN study-specific, baseline CPET will be conducted to ensure patient meets the entry criteria.","confidence":1,"confidence_rate":1},{"cnt":[[245,877],[1772,877],[1772,924],[245,924]],"region":{"top_left_x":244,"top_left_y":876,"width":1529,"height":48},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1d9042e80ddb418f87c6f943bafbe223","type":"text","conversion_output":true,"text":"Patients that do not meet the CPET criteria will be considered a screen failure and will not","text_display":" Patients that do not meet the CPET criteria will be considered a screen failure and will not","confidence":1,"confidence_rate":1},{"cnt":[[245,928],[1807,928],[1807,978],[245,978]],"region":{"top_left_x":244,"top_left_y":928,"width":1563,"height":50},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a9c5281682eb49a9bbe6a1cfcfd703f2","type":"text","conversion_output":true,"text":"continue. Note: The baseline bloods are to be obtained prior to the CPET as the biomarker","text_display":" continue. Note: The baseline bloods are to be obtained prior to the CPET as the biomarker","confidence":1,"confidence_rate":1},{"cnt":[[245,975],[1876,975],[1876,1027],[245,1027]],"region":{"top_left_x":244,"top_left_y":975,"width":1632,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d8581a5cc44d44d5af0cb4b0a7885903","type":"text","conversion_output":true,"text":"values can be affected from the exertion of the CPET. In the event this is not feasible, the blood","text_display":" values can be affected from the exertion of the CPET. In the event this is not feasible, the blood","confidence":1,"confidence_rate":1},{"cnt":[[245,1027],[1652,1027],[1652,1079],[245,1079]],"region":{"top_left_x":244,"top_left_y":1026,"width":1409,"height":53},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4e17fa6131ef445f93af650127556e16","type":"text","conversion_output":true,"text":"draws will need to be obtained 3 hours post CPET and prior to the run-in test dose.","text_display":" draws will need to be obtained 3 hours post CPET and prior to the run-in test dose.","confidence":1,"confidence_rate":1},{"cnt":[[245,1130],[1781,1130],[1781,1179],[245,1179]],"region":{"top_left_x":244,"top_left_y":1130,"width":1538,"height":50},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b961dde5c6714b3f899c3d48a7c7fb40","type":"text","conversion_output":true,"text":"Once confirmed, patients will undergo the remaining baseline studies (below) and undergo","text_display":"\n\nOnce confirmed, patients will undergo the remaining baseline studies (below) and undergo","confidence":1,"confidence_rate":1},{"cnt":[[245,1177],[1833,1177],[1833,1231],[245,1231]],"region":{"top_left_x":244,"top_left_y":1177,"width":1589,"height":55},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"99382562cdcc4e8587e065e9b827b34b","type":"text","conversion_output":true,"text":"single dose unblinded run-in receiving 80 mg nebulized sodium nitrite followed by observation","text_display":" single dose unblinded run-in receiving 80 mg nebulized sodium nitrite followed by observation","confidence":1,"confidence_rate":1},{"cnt":[[245,1229],[1568,1229],[1568,1278],[245,1278]],"region":{"top_left_x":244,"top_left_y":1228,"width":1325,"height":51},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"feb1a6b042d3405188334c4409f04bc0","type":"text","conversion_output":true,"text":"for 60 minutes. Patients that do not tolerate the run-in will not be randomized.","text_display":" for 60 minutes. Patients that do not tolerate the run-in will not be randomized.","confidence":1,"confidence_rate":1},{"cnt":[[245,1332],[1772,1332],[1772,1381],[245,1381]],"region":{"top_left_x":244,"top_left_y":1332,"width":1529,"height":50},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b075ead52dd04da19bb0caca8837d84a","type":"text","conversion_output":true,"text":"Qualifying patients will be randomized using procedures determined by the CC to one of 2","text_display":"\n\nQualifying patients will be randomized using procedures determined by the CC to one of 2","confidence":1,"confidence_rate":1},{"cnt":[[245,1379],[1749,1379],[1749,1433],[245,1433]],"region":{"top_left_x":244,"top_left_y":1379,"width":1505,"height":55},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"638711f40e7f4d5e9803a2bcd5800336","type":"text","conversion_output":true,"text":"sequences (inorganic nitrite first or placebo first). Participants will be randomized in a \\(1: 1\\)","text_display":" sequences (inorganic nitrite first or placebo first). Participants will be randomized in a \\(1: 1\\)","confidence":1,"confidence_rate":1},{"cnt":[[245,1431],[1841,1431],[1841,1485],[245,1485]],"region":{"top_left_x":244,"top_left_y":1430,"width":1598,"height":55},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8d2befa57a9e4d20b6f0e69720312571","type":"text","conversion_output":true,"text":"allocation ratio. The Participants will be educated in study procedures including wearing of the","text_display":" allocation ratio. The Participants will be educated in study procedures including wearing of the","confidence":1,"confidence_rate":1},{"cnt":[[245,1482],[1800,1482],[1800,1532],[245,1532]],"region":{"top_left_x":244,"top_left_y":1482,"width":1557,"height":50},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a6339ee1badc4076980ab8701b525779","type":"text","conversion_output":true,"text":"accelerometer and use of the nebulizer device. Participants will be required to demonstrate","text_display":" accelerometer and use of the nebulizer device. Participants will be required to demonstrate","confidence":1,"confidence_rate":1},{"cnt":[[245,1532],[1863,1532],[1863,1583],[245,1583]],"region":{"top_left_x":244,"top_left_y":1531,"width":1619,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2f3792fab3545bab12f26808b784a38","type":"text","conversion_output":true,"text":"independent proficiency with the nebulizer prior to dismissal from Visit 1. Study drug for the first","text_display":" independent proficiency with the nebulizer prior to dismissal from Visit 1. Study drug for the first","confidence":0.8733508586883545,"confidence_rate":0.9987111369754917},{"cnt":[[245,1583],[958,1583],[958,1635],[245,1635]],"region":{"top_left_x":244,"top_left_y":1583,"width":715,"height":52},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4745e3613a1e4711a53db2ba6729d978","type":"text","conversion_output":true,"text":"phase of INDIE-HFpEF will be dispensed.","text_display":" phase of INDIE-HFpEF will be dispensed.","confidence":1,"confidence_rate":1},{"cnt":[[245,1684],[1141,1684],[1141,1734],[245,1734]],"region":{"top_left_x":244,"top_left_y":1684,"width":897,"height":50},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4c0d68e040924f15812c7cb2547df949","type":"text","conversion_output":true,"text":"Remaining baseline studies and procedures include:","text_display":"\n\nRemaining baseline studies and procedures 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immediate risk of death at the time of the","confidence":1,"confidence_rate":1},{"cnt":[[370,254],[1867,254],[1867,299],[370,299]],"region":{"top_left_x":369,"top_left_y":253,"width":1498,"height":46},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7e6ab66cd73844cb9e783de517de4643","type":"text","conversion_output":true,"text":"event as it occurred. It does not include an AE that, had it occurred in a more severe form,","text_display":" event as it occurred. It does not include an AE that, had it occurred in a more severe form,","confidence":0.92822265625,"confidence_rate":0.9992324221235664},{"cnt":[[370,305],[806,305],[806,350],[370,350]],"region":{"top_left_x":369,"top_left_y":305,"width":437,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"88174eb9e72741329a8a6d7bd944590f","type":"text","conversion_output":true,"text":"might have caused death.","text_display":" might have caused death.","confidence":1,"confidence_rate":1},{"cnt":[[309,357],[1863,357],[1863,406],[309,406]],"region":{"top_left_x":309,"top_left_y":356,"width":1554,"height":51},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aa685bd70ec643a1a458fa108f24e32b","type":"text","conversion_output":true,"text":"- Persistent or significant incapacity or substantial disruption of the ability to conduct normal","text_display":"\n- Persistent or significant incapacity or substantial disruption of the 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hospitalization.","confidence":1,"confidence_rate":1},{"cnt":[[309,516],[956,516],[956,561],[309,561]],"region":{"top_left_x":309,"top_left_y":515,"width":648,"height":46},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c17fb24323644184b7aa7c465714b1c2","type":"text","conversion_output":true,"text":"- Congenital anomaly or birth defect.","text_display":"\n- Congenital anomaly or birth defect.","confidence":1,"confidence_rate":1},{"cnt":[[309,567],[1755,567],[1755,612],[309,612]],"region":{"top_left_x":309,"top_left_y":567,"width":1447,"height":46},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"fa16012b2cbb4b59bc8975653a49c878","type":"text","conversion_output":true,"text":"- Important medical events that may not result in death, be life threatening, or require","text_display":"\n- Important medical events that may not result in death, be life threatening, or 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participant and may require medical or surgical","confidence":1,"confidence_rate":1},{"cnt":[[372,718],[1583,718],[1583,767],[372,767]],"region":{"top_left_x":371,"top_left_y":717,"width":1213,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"082ff6be5c8746a1a4fec83d6e9c5d03","type":"text","conversion_output":true,"text":"intervention to prevent one of the outcomes listed in this definition above.","text_display":" intervention to prevent one of the outcomes listed in this definition above.","confidence":1,"confidence_rate":1},{"cnt":[[245,769],[1815,769],[1815,816],[245,816]],"region":{"top_left_x":244,"top_left_y":769,"width":1572,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d2f92044eb4e42b3a3d00d64d0eae340","type":"text","conversion_output":true,"text":"This determination is based on the opinion of either the investigator or sponsor (e.g., if either","text_display":"\nThis determination 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to have the investigational product discontinued or interrupted or required the participant to","confidence":1,"confidence_rate":1},{"cnt":[[245,1083],[1841,1083],[1841,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1082,"width":1598,"height":51},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9d7a031d8a414b1fba9b9df98132a6c2","type":"text","conversion_output":true,"text":"receive specific corrective therapy, the clinical diagnosis rather than the laboratory term will be","text_display":" receive specific corrective therapy, the clinical diagnosis rather than the laboratory term will be","confidence":0.9990234375,"confidence_rate":0.9999906054321309},{"cnt":[[245,1134],[1575,1134],[1575,1184],[245,1184]],"region":{"top_left_x":244,"top_left_y":1134,"width":1331,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7c7875cf84bb4b9389542ce0f964e494","type":"text","conversion_output":true,"text":"used 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available information, using the following guidelines:","text_display":" drug, based on available information, using the following guidelines:","confidence":1,"confidence_rate":1},{"cnt":[[309,1401],[1830,1401],[1830,1450],[309,1450]],"region":{"top_left_x":309,"top_left_y":1400,"width":1522,"height":51},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf79e9bf6ec149d98e1041d70698f3af","type":"text","conversion_output":true,"text":"- Not related: There is not a reasonable causal relationship to the investigational product","text_display":"\n- Not related: There is not a reasonable causal relationship to the investigational product","confidence":1,"confidence_rate":1},{"cnt":[[370,1452],[758,1452],[758,1497],[370,1497]],"region":{"top_left_x":369,"top_left_y":1452,"width":390,"height":46},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cb968c36b1614bc38597a76c7273ae1d","type":"text","conversion_output":true,"text":"and 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Any AE that is not identified in nature, severity, or specificity in the","text_display":" investigator's brochure. Any AE that is not identified in nature, severity, or specificity in the","confidence":0.99951171875,"confidence_rate":0.999995211771286},{"cnt":[[247,2535],[844,2535],[844,2572],[247,2572]],"region":{"top_left_x":247,"top_left_y":2535,"width":598,"height":37},"line":45,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"abcd8f8961464a81b0e36eaf954b24fa","type":"page_info","conversion_output":false,"text":"INDIE-HFpEF Protocol v1.3, 22April2016 (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1822,2539],[1869,2539],[1869,2574],[1822,2574]],"region":{"top_left_x":1821,"top_left_y":2539,"width":49,"height":35},"line":46,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"a54d436b959f45678bc85c6e493fa7a7","type":"page_info","conversion_output":false,"text":"35","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"2797815c-2843-46aa-81fc-4fe2b5548cd2-36","page":36,"lines":[{"cnt":[[245,200],[1781,200],[1781,247],[245,247]],"region":{"top_left_x":244,"top_left_y":199,"width":1538,"height":49},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f3fa3fa59b334d2a871f6af9121999c2","type":"text","conversion_output":true,"text":"current investigator's brochure is considered unexpected. Events that are mentioned in the","text_display":"\ncurrent investigator's brochure is considered unexpected. Events that are mentioned in the","confidence":1,"confidence_rate":1},{"cnt":[[245,245],[1652,245],[1652,294],[245,294]],"region":{"top_left_x":244,"top_left_y":244,"width":1409,"height":51},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"bab6905628354418851937e13a4757b5","type":"text","conversion_output":true,"text":"investigator's brochure as occurring with a class of drugs or as anticipated from the","text_display":" investigator's brochure as occurring with a class of drugs or as anticipated from the","confidence":1,"confidence_rate":1},{"cnt":[[245,288],[1790,288],[1790,337],[245,337]],"region":{"top_left_x":244,"top_left_y":287,"width":1546,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"aaa95e9584cf418b889f9af6c0463209","type":"text","conversion_output":true,"text":"pharmacological properties of the drug, but not specifically mentioned as occurring with the","text_display":" pharmacological properties of the drug, but not specifically mentioned as occurring with the","confidence":1,"confidence_rate":1},{"cnt":[[245,335],[1308,335],[1308,380],[245,380]],"region":{"top_left_x":244,"top_left_y":335,"width":1065,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bb7281f27af474c87ad3b6ebcbc7f8f","type":"text","conversion_output":true,"text":"particular drug under investigation are considered unexpected.","text_display":" particular drug under investigation are considered 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The investigator or qualified designee will enter the required","confidence":1,"confidence_rate":1},{"cnt":[[245,2144],[1704,2144],[1704,2196],[245,2196]],"region":{"top_left_x":244,"top_left_y":2144,"width":1460,"height":52},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5adba81decaf4fa39c125efe850947e9","type":"text","conversion_output":true,"text":"information regarding the AE/SAE into the appropriate module of the eCRF, which will","text_display":" information regarding the AE/SAE into the appropriate module of the eCRF, which will","confidence":1,"confidence_rate":1},{"cnt":[[245,2196],[1824,2196],[1824,2247],[245,2247]],"region":{"top_left_x":244,"top_left_y":2195,"width":1581,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3da1383ed1334a3fb8cd057c183e41d0","type":"text","conversion_output":true,"text":"automatically result in distribution of the information to DCRI Safety Surveillance. If the eCRF","text_display":" automatically result in distribution of the information to DCRI Safety Surveillance. If the eCRF","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,2245],[1841,2245],[1841,2297],[245,2297]],"region":{"top_left_x":244,"top_left_y":2245,"width":1598,"height":52},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79f80158874d4a24b37b6464927a6dd3","type":"text","conversion_output":true,"text":"system is temporarily unavailable, the event, including the investigator-determined causality to","text_display":" system is temporarily unavailable, the event, including the investigator-determined causality to","confidence":1,"confidence_rate":1},{"cnt":[[245,2297],[1807,2297],[1807,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2296,"width":1563,"height":53},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"79f1d34d9b1143f7a139074af312e338","type":"text","conversion_output":true,"text":"study drug should be reported via the back-up paper SAE form to DCRI Safety Surveillance.","text_display":" study drug should be reported via the back-up paper SAE form to DCRI Safety Surveillance.","confidence":1,"confidence_rate":1},{"cnt":[[245,2346],[1861,2346],[1861,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2346,"width":1617,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9e653ca53f2b464b91fb1986cc58be27","type":"text","conversion_output":true,"text":"Upon return of the availability of the electronic data capture (EDC) system, the SAE information","text_display":" Upon return of the availability of the electronic data capture (EDC) system, the SAE information","confidence":1,"confidence_rate":1},{"cnt":[[245,2398],[786,2398],[786,2447],[245,2447]],"region":{"top_left_x":244,"top_left_y":2397,"width":543,"height":51},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b76970076699461f907131b8edc8ad58","type":"text","conversion_output":true,"text":"must be entered 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The Investigator will follow all reportable events until resolution, stabilization or the event","text_display":" above. 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Follow-up reports will be sent to investigators to","text_display":" SAR in light of the previous, similar reports. 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The pregnancy","confidence":0.9990234375,"confidence_rate":0.9999897154250147},{"cnt":[[247,1895],[1798,1895],[1798,1936],[247,1936]],"region":{"top_left_x":247,"top_left_y":1894,"width":1552,"height":42},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"09d116efc64e4c2983a1015d65ece8f3","type":"text","conversion_output":true,"text":"will be followed until final outcome. Any associated AEs or SAEs that occur to the mother or","text_display":" will be followed until final outcome. Any associated AEs or SAEs that occur to the mother or","confidence":1,"confidence_rate":1},{"cnt":[[247,1944],[1390,1944],[1390,1987],[247,1987]],"region":{"top_left_x":247,"top_left_y":1944,"width":1144,"height":44},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"98c79c89ea4b419f827e3bf5bb4910d4","type":"text","conversion_output":true,"text":"fetus will be recorded in the AE/SAE eCRF, within the EDC system.","text_display":" fetus will be recorded in the AE/SAE eCRF, within the EDC system.","confidence":1,"confidence_rate":1},{"cnt":[[249,2105],[1042,2105],[1042,2155],[249,2155]],"region":{"top_left_x":249,"top_left_y":2105,"width":793,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d508aad50650469d8d4e422b4f40fe78","type":"section_header","conversion_output":false,"children_ids":["414a66dce12f421b9a2b8be6f63301a9"],"text":"","text_display":""},{"cnt":[[249,2110],[1040,2110],[1040,2151],[249,2151]],"region":{"top_left_x":249,"top_left_y":2109,"width":791,"height":42},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"414a66dce12f421b9a2b8be6f63301a9","type":"text","conversion_output":true,"parent_id":"d508aad50650469d8d4e422b4f40fe78","text":"17 STATISTICAL CONSIDERATIONS","text_display":"\n\n\\section*{17 STATISTICAL CONSIDERATIONS}","confidence":0.99951171875,"confidence_rate":0.9999852000944255},{"cnt":[[249,2221],[526,2221],[526,2262],[249,2262]],"region":{"top_left_x":249,"top_left_y":2221,"width":278,"height":42},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c47dae8faa584a628fc395f72f8baa36","type":"section_header","conversion_output":false,"children_ids":["441dcd6fc3ba4948807d7b9891a96e1e"],"text":"","text_display":""},{"cnt":[[251,2226],[526,2226],[526,2258],[251,2258]],"region":{"top_left_x":251,"top_left_y":2225,"width":276,"height":34},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"441dcd6fc3ba4948807d7b9891a96e1e","type":"text","conversion_output":true,"parent_id":"c47dae8faa584a628fc395f72f8baa36","text":"17.1 Overview","text_display":"\n\n\\subsection*{17.1 Overview}","confidence":0.99609375,"confidence_rate":0.9997825847869395},{"cnt":[[245,2295],[1867,2295],[1867,2340],[245,2340]],"region":{"top_left_x":244,"top_left_y":2294,"width":1623,"height":46},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5913efb6e577428780d9068ac4a1b2ac","type":"text","conversion_output":true,"text":"All planned analyses will be prospectively defined for this study and approved by the CC prior to","text_display":"\n\nAll planned analyses will be prospectively defined for this study and approved by the CC prior to","confidence":1,"confidence_rate":1},{"cnt":[[249,2346],[1755,2346],[1755,2387],[249,2387]],"region":{"top_left_x":249,"top_left_y":2346,"width":1507,"height":41},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a42e3d4ea2e44e50bb0a1a83243673e1","type":"text","conversion_output":true,"text":"unblinding of data. In addition, exploratory analyses will be performed to help explain and","text_display":" unblinding of data. In addition, exploratory analyses will be performed to help explain and","confidence":1,"confidence_rate":1},{"cnt":[[249,2396],[1867,2396],[1867,2438],[249,2438]],"region":{"top_left_x":249,"top_left_y":2395,"width":1618,"height":44},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e5e04103b9d546b3ba4e6233b367aebe","type":"text","conversion_output":true,"text":"understand findings observed from the planned analyses. Statistical tests with a 2 -sided p -value","text_display":" understand findings observed from the planned analyses. Statistical tests with a 2 -sided p -value","confidence":0.99755859375,"confidence_rate":0.9999781753154674},{"cnt":[[249,2445],[1751,2445],[1751,2490],[249,2490]],"region":{"top_left_x":249,"top_left_y":2444,"width":1502,"height":47},"line":41,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"db3f828f66c24fc5b0d76c780f3100b9","type":"text","conversion_output":true,"text":"\\(<0.05\\) will be considered statistically significant, unless otherwise stated. Analyses will be","text_display":" \\(<0.05\\) will be considered statistically significant, unless otherwise stated. Analyses will be","confidence":0.77685546875,"confidence_rate":0.9974002824758486},{"cnt":[[249,2539],[844,2539],[844,2572],[249,2572]],"region":{"top_left_x":249,"top_left_y":2539,"width":596,"height":33},"line":42,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"2847d0c4044d429285b4940163e98175","type":"page_info","conversion_output":false,"text":"INDIE-HFpEF Protocol v1.3, 22April2016 (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1822,2539],[1869,2539],[1869,2574],[1822,2574]],"region":{"top_left_x":1821,"top_left_y":2539,"width":49,"height":35},"line":43,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"d0ffba47aed34a81b0bcfee1a3ed2576","type":"page_info","conversion_output":false,"text":"37","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"2797815c-2843-46aa-81fc-4fe2b5548cd2-38","page":38,"lines":[{"cnt":[[245,198],[1781,198],[1781,251],[245,251]],"region":{"top_left_x":244,"top_left_y":197,"width":1538,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a969d77ba89c4a4ca10c07358453d77f","type":"text","conversion_output":true,"text":"performed using SAS software (SAS Institute, Inc, Cary, NC). The INDIE-HFpEF statistical","text_display":"\nperformed using SAS software (SAS Institute, Inc, Cary, NC). The INDIE-HFpEF statistical","confidence":0.9990234375,"confidence_rate":0.9999894942525209},{"cnt":[[245,249],[1835,249],[1835,299],[245,299]],"region":{"top_left_x":244,"top_left_y":249,"width":1591,"height":50},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"361062ebd006406daf97b3af0847937c","type":"text","conversion_output":true,"text":"analysis plan (SAP) will contain detailed information regarding the data analysis. The SAP will","text_display":" analysis plan (SAP) will contain detailed information regarding the data analysis. The SAP will","confidence":1,"confidence_rate":1},{"cnt":[[245,301],[1824,301],[1824,350],[245,350]],"region":{"top_left_x":244,"top_left_y":300,"width":1581,"height":51},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3fa1591bf49a4ae09f8b036af36eaff9","type":"text","conversion_output":true,"text":"be finalized prior to trial completion and will be approved by the coordinating center statistical","text_display":" be finalized prior to trial completion and will be approved by the coordinating center statistical","confidence":0.998046875,"confidence_rate":0.9999810192594005},{"cnt":[[245,352],[982,352],[982,402],[245,402]],"region":{"top_left_x":244,"top_left_y":352,"width":738,"height":50},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9f7b9a5cd57045a08a37bfecc4741fbb","type":"text","conversion_output":true,"text":"team as well as the NHLBI program officer.","text_display":" team as well as the NHLBI program officer.","confidence":1,"confidence_rate":1},{"cnt":[[243,451],[902,451],[902,511],[243,511]],"region":{"top_left_x":242,"top_left_y":451,"width":661,"height":61},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"353a535d255f4899a94f6f3d626ea4c1","type":"section_header","conversion_output":false,"children_ids":["1677891c42204c7c869285bb5e224a9d"],"text":"","text_display":""},{"cnt":[[249,460],[896,460],[896,507],[249,507]],"region":{"top_left_x":249,"top_left_y":459,"width":647,"height":49},"line":6,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1677891c42204c7c869285bb5e224a9d","type":"text","conversion_output":true,"parent_id":"353a535d255f4899a94f6f3d626ea4c1","text":"17.2 Design and Analytical Criteria","text_display":"\n\n\\subsection*{17.2 Design and Analytical Criteria}","confidence":0.99609375,"confidence_rate":0.9999021573038804},{"cnt":[[245,529],[1841,529],[1841,578],[245,578]],"region":{"top_left_x":244,"top_left_y":528,"width":1598,"height":50},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"dd1fcce339a0489e9d8a5ab16ef0b09f","type":"text","conversion_output":true,"text":"The primary analysis will be conducted on an intention-to-treat (ITT) basis. The ITT population","text_display":"\n\nThe primary analysis will be conducted on an intention-to-treat (ITT) basis. The ITT population","confidence":1,"confidence_rate":1},{"cnt":[[245,580],[1781,580],[1781,629],[245,629]],"region":{"top_left_x":244,"top_left_y":580,"width":1538,"height":50},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ba4f5d6b552b493e96cbc03322dc7d0e","type":"text","conversion_output":true,"text":"includes all participants who are randomized. The primary endpoint is based on the within-","text_display":" includes all participants who are randomized. The primary endpoint is based on the within","confidence":1,"confidence_rate":1},{"cnt":[[245,629],[1854,629],[1854,681],[245,681]],"region":{"top_left_x":244,"top_left_y":629,"width":1611,"height":53},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"64725b6b3b9d4ca29372ac26d20d00c5","type":"text","conversion_output":true,"text":"patient comparison of peak \\(VO _{2}\\) following 4 weeks treatment with inorganic nitrite as compared","text_display":"patient comparison of peak \\(VO _{2}\\) following 4 weeks treatment with inorganic nitrite as compared","confidence":0.994145393371582,"confidence_rate":0.9999484942034467},{"cnt":[[245,679],[1871,679],[1871,728],[245,728]],"region":{"top_left_x":244,"top_left_y":678,"width":1628,"height":51},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"969709ec0f0e416c9e43a3dbc04817e9","type":"text","conversion_output":true,"text":"to following 4 weeks treatment with placebo. It is anticipated that some data will be missing due","text_display":" to following 4 weeks treatment with placebo. It is anticipated that some data will be missing due","confidence":1,"confidence_rate":1},{"cnt":[[245,730],[1354,730],[1354,780],[245,780]],"region":{"top_left_x":244,"top_left_y":730,"width":1110,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6b78c5338b0483ebbf6284e86c98089","type":"text","conversion_output":true,"text":"to participant drop out or inability to complete both exercise tests.","text_display":" to participant drop out or inability to complete both exercise tests.","confidence":1,"confidence_rate":1},{"cnt":[[245,831],[1824,831],[1824,883],[245,883]],"region":{"top_left_x":244,"top_left_y":831,"width":1581,"height":53},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"369b851259c64bbe897be2ab853eaaef","type":"text","conversion_output":true,"text":"The primary data analysis of the primary endpoint will involve a mixed model with fixed effect","text_display":"\n\nThe primary data analysis of the primary endpoint will involve a mixed model with fixed effect","confidence":1,"confidence_rate":1},{"cnt":[[245,881],[1738,881],[1738,930],[245,930]],"region":{"top_left_x":244,"top_left_y":880,"width":1495,"height":51},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a51d7100af6848a6b6c949552ae226a9","type":"text","conversion_output":true,"text":"terms for the sequence, period and treatment. When available, the baseline value of the","text_display":" terms for the sequence, period and treatment. When available, the baseline value of the","confidence":1,"confidence_rate":1},{"cnt":[[245,932],[1841,932],[1841,982],[245,982]],"region":{"top_left_x":244,"top_left_y":932,"width":1598,"height":50},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f84136253b304dbca6dace2138466077","type":"text","conversion_output":true,"text":"variable will be included in the model. A random effect term will be included to account for the","text_display":" variable will be included in the model. A random effect term will be included to account for the","confidence":1,"confidence_rate":1},{"cnt":[[245,982],[1742,982],[1742,1033],[245,1033]],"region":{"top_left_x":244,"top_left_y":981,"width":1499,"height":53},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ce2272b46de437a9fd3ee2df8e42ca7","type":"text","conversion_output":true,"text":"correlated measurements within each participant. The estimated treatment effect will be","text_display":" correlated measurements within each participant. The estimated treatment effect will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1033],[1833,1033],[1833,1085],[245,1085]],"region":{"top_left_x":244,"top_left_y":1033,"width":1589,"height":52},"line":16,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6c7b49539ed141ffbe7ac5fbec1643ff","type":"text","conversion_output":true,"text":"provided with a \\(95 \\%\\) confidence interval. Given the short half-life of the drug ( 40 minutes), the","text_display":" provided with a \\(95 \\%\\) confidence interval. Given the short half-life of the drug ( 40 minutes), the","confidence":1,"confidence_rate":1},{"cnt":[[245,1083],[1790,1083],[1790,1132],[245,1132]],"region":{"top_left_x":244,"top_left_y":1082,"width":1546,"height":51},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5ec0a3c9bdfd48ff99bcaa63d07180d7","type":"text","conversion_output":true,"text":"two-week washout period, and the assumed lack of remodeling effects with this duration of","text_display":" two-week washout period, and the assumed lack of remodeling effects with this duration of","confidence":1,"confidence_rate":1},{"cnt":[[245,1134],[1811,1134],[1811,1188],[245,1188]],"region":{"top_left_x":244,"top_left_y":1134,"width":1568,"height":55},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"b198a5dfc4ea422d9cedab681b409190","type":"text","conversion_output":true,"text":"treatment, we anticipate no significant carry-over or residual effect from Phase 1 to Phase 2.","text_display":" treatment, we anticipate no significant carry-over or residual effect from Phase 1 to Phase 2.","confidence":1,"confidence_rate":1},{"cnt":[[245,1233],[1865,1233],[1865,1287],[245,1287]],"region":{"top_left_x":244,"top_left_y":1233,"width":1621,"height":54},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"78c56af13fb9461f8137e37555faf42a","type":"text","conversion_output":true,"text":"Baseline data will be collected to characterize the study population and potentially to serve as a","text_display":"\n\nBaseline data will be collected to characterize the study population and potentially to serve as a","confidence":1,"confidence_rate":1},{"cnt":[[245,1285],[1833,1285],[1833,1338],[245,1338]],"region":{"top_left_x":244,"top_left_y":1284,"width":1589,"height":55},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"3e95fb3881b84f0b8cab659ab08cd44f","type":"text","conversion_output":true,"text":"covariate in the analysis of the endpoints and to facilitate subgroup analysis, including tertiary","text_display":" covariate in the analysis of the endpoints and to facilitate subgroup analysis, including tertiary","confidence":1,"confidence_rate":1},{"cnt":[[245,1336],[1871,1336],[1871,1388],[245,1388]],"region":{"top_left_x":244,"top_left_y":1336,"width":1628,"height":52},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"55fa74dfe9e7464d9b36631485105f53","type":"text","conversion_output":true,"text":"endpoint analyses. As a sensitivity analysis, the data from the first period and second period will","text_display":" endpoint analyses. As a sensitivity analysis, the data from the first period and second period will","confidence":1,"confidence_rate":1},{"cnt":[[245,1386],[1876,1386],[1876,1437],[245,1437]],"region":{"top_left_x":244,"top_left_y":1385,"width":1632,"height":53},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2ab47fb6841f40d28c8245bf1b49faa8","type":"text","conversion_output":true,"text":"be presented and analyzed separately. Exploratory analyses will be conducted using the paired","text_display":" be presented and analyzed separately. Exploratory analyses will be conducted using the paired","confidence":1,"confidence_rate":1},{"cnt":[[245,1437],[1207,1437],[1207,1489],[245,1489]],"region":{"top_left_x":244,"top_left_y":1437,"width":964,"height":52},"line":23,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"391cd9b200554d94863541c3b242ba24","type":"text","conversion_output":true,"text":"t-test and the t-test using the crossover design structure.","text_display":" t-test and the t-test using the crossover design structure.","confidence":0.99951171875,"confidence_rate":0.999992368771335},{"cnt":[[243,1538],[1199,1538],[1199,1601],[243,1601]],"region":{"top_left_x":242,"top_left_y":1538,"width":957,"height":63},"line":24,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"6d56863c5f264bfe8c2e7fe3c36b77ab","type":"section_header","conversion_output":false,"children_ids":["7d570315d3f4477db73a95c74e28618f"],"text":"","text_display":""},{"cnt":[[249,1543],[1192,1543],[1192,1594],[249,1594]],"region":{"top_left_x":249,"top_left_y":1542,"width":944,"height":53},"line":25,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7d570315d3f4477db73a95c74e28618f","type":"text","conversion_output":true,"parent_id":"6d56863c5f264bfe8c2e7fe3c36b77ab","text":"17.3 Analysis of Secondary and Tertiary Endpoints","text_display":"\n\n\\subsection*{17.3 Analysis of Secondary and Tertiary Endpoints}","confidence":1,"confidence_rate":1},{"cnt":[[245,1616],[1813,1616],[1813,1665],[245,1665]],"region":{"top_left_x":244,"top_left_y":1615,"width":1570,"height":51},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"a7b3d397197f44b5bd98cce96e112311","type":"text","conversion_output":true,"text":"Analysis of continuous outcomes will be conducted using mixed models as described above.","text_display":"\n\nAnalysis of continuous outcomes will be conducted using mixed models as described above.","confidence":1,"confidence_rate":1},{"cnt":[[245,1663],[1850,1663],[1850,1717],[245,1717]],"region":{"top_left_x":244,"top_left_y":1662,"width":1606,"height":55},"line":27,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f7c3417e71044331ad8e2139f43276e2","type":"text","conversion_output":true,"text":"For endpoints such as NT-proBNP, we will consider transformations of the data to obtain more","text_display":" For endpoints such as NT-proBNP, we will consider transformations of the data to obtain more","confidence":1,"confidence_rate":1},{"cnt":[[245,1714],[1798,1714],[1798,1766],[245,1766]],"region":{"top_left_x":244,"top_left_y":1714,"width":1555,"height":53},"line":28,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"52d8c5d027a44daf8055fef2f2fb1a9b","type":"text","conversion_output":true,"text":"valid \\(95 \\%\\) confidence intervals. For nominal variables, the number and percentages in each","text_display":" valid \\(95 \\%\\) confidence intervals. For nominal variables, the number and percentages in each","confidence":1,"confidence_rate":1},{"cnt":[[245,1766],[1876,1766],[1876,1818],[245,1818]],"region":{"top_left_x":244,"top_left_y":1766,"width":1632,"height":52},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e174fbf1f82c4c2cb28a94ee31eea9e7","type":"text","conversion_output":true,"text":"category will be presented. For binary outcomes, Chi-square tests and Fisher's exact test will be","text_display":" category will be presented. For binary outcomes, Chi-square tests and Fisher's exact test will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1818],[827,1818],[827,1867],[245,1867]],"region":{"top_left_x":244,"top_left_y":1817,"width":584,"height":50},"line":30,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2bf10155d11347b9a369a1b61620ed58","type":"text","conversion_output":true,"text":"used for unadjusted comparisons.","text_display":" used for unadjusted comparisons.","confidence":1,"confidence_rate":1},{"cnt":[[241,1916],[1386,1916],[1386,1981],[241,1981]],"region":{"top_left_x":240,"top_left_y":1916,"width":1146,"height":65},"line":31,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8dc10d3c7fdf47be91924964f0d1e4a5","type":"section_header","conversion_output":false,"children_ids":["945aedc6a4f2404492324b23bfac42f6"],"text":"","text_display":""},{"cnt":[[247,1921],[1379,1921],[1379,1974],[247,1974]],"region":{"top_left_x":247,"top_left_y":1920,"width":1133,"height":55},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"945aedc6a4f2404492324b23bfac42f6","type":"text","conversion_output":true,"parent_id":"8dc10d3c7fdf47be91924964f0d1e4a5","text":"17.4 Analysis of Safety Data and Statistical Monitoring Plan","text_display":"\n\n\\subsection*{17.4 Analysis of Safety Data and Statistical Monitoring Plan}","confidence":1,"confidence_rate":1},{"cnt":[[245,1996],[1815,1996],[1815,2047],[245,2047]],"region":{"top_left_x":244,"top_left_y":1995,"width":1572,"height":53},"line":33,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8a1e9762958449dda1dfae1c112a7c9d","type":"text","conversion_output":true,"text":"Interim data analysis for efficacy and futility will not be conducted due to relatively small size,","text_display":"\n\nInterim data analysis for efficacy and futility will not be conducted due to relatively small size,","confidence":1,"confidence_rate":1},{"cnt":[[245,2045],[1772,2045],[1772,2095],[245,2095]],"region":{"top_left_x":244,"top_left_y":2045,"width":1529,"height":50},"line":34,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2777043c79f543a4b0033aae17c3cc35","type":"text","conversion_output":true,"text":"short duration, and crossover structure of this clinical trial. Safety data, summarized at the","text_display":" short duration, and crossover structure of this clinical trial. Safety data, summarized at the","confidence":1,"confidence_rate":1},{"cnt":[[245,2093],[1811,2093],[1811,2146],[245,2146]],"region":{"top_left_x":244,"top_left_y":2092,"width":1568,"height":55},"line":35,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ca15b4d1aa4f419da9c0bcaf1620a25b","type":"text","conversion_output":true,"text":"treatment level, will be assessed approximately every 6 months by the National Heart, Lung,","text_display":" treatment level, will be assessed approximately every 6 months by the National Heart, Lung,","confidence":0.9956073760986328,"confidence_rate":0.9999555333137305},{"cnt":[[245,2144],[1841,2144],[1841,2198],[245,2198]],"region":{"top_left_x":244,"top_left_y":2144,"width":1598,"height":54},"line":36,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"18135e402004410ab6c91085504ba8c3","type":"text","conversion_output":true,"text":"and Blood Institute (NHLBI)-appointed DSMB. The safety analyses will be based on the entire","text_display":" and Blood Institute (NHLBI)-appointed DSMB. The safety analyses will be based on the entire","confidence":0.99951171875,"confidence_rate":0.9999949125077526},{"cnt":[[245,2196],[1796,2196],[1796,2247],[245,2247]],"region":{"top_left_x":244,"top_left_y":2195,"width":1553,"height":53},"line":37,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1a062b47d1ec456c9990aa0ec7f6beee","type":"text","conversion_output":true,"text":"ITT population. Safety will be evaluated by comparing the occurrence of AEs. Based on the","text_display":" ITT population. Safety will be evaluated by comparing the occurrence of AEs. Based on the","confidence":1,"confidence_rate":1},{"cnt":[[245,2245],[1869,2245],[1869,2299],[245,2299]],"region":{"top_left_x":244,"top_left_y":2245,"width":1626,"height":54},"line":38,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"e188a2ded29249e0900d2b2c2f65be1d","type":"text","conversion_output":true,"text":"RELAX-HFpEF study performed in patients with HFpEF within the HFN, we expect the mortality","text_display":" RELAX-HFpEF study performed in patients with HFpEF within the HFN, we expect the mortality","confidence":1,"confidence_rate":1},{"cnt":[[245,2295],[1751,2295],[1751,2348],[245,2348]],"region":{"top_left_x":244,"top_left_y":2294,"width":1507,"height":55},"line":39,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"0f7e7693309f457193069d81ddd21048","type":"text","conversion_output":true,"text":"rate over the 12 -week study period to be less than \\(2 \\%\\) (Data on file at DCRI; RELAX trial","text_display":" rate over the 12 -week study period to be less than \\(2 \\%\\) (Data on file at DCRI; RELAX trial","confidence":0.9990236759185791,"confidence_rate":0.9999902320377446},{"cnt":[[245,2346],[415,2346],[415,2400],[245,2400]],"region":{"top_left_x":244,"top_left_y":2346,"width":171,"height":54},"line":40,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"97fcefbcec604bbba580ad29260a6e76","type":"text","conversion_output":true,"text":"analysis).","text_display":" analysis).","confidence":1,"confidence_rate":1},{"cnt":[[245,2535],[846,2535],[846,2576],[245,2576]],"region":{"top_left_x":244,"top_left_y":2535,"width":603,"height":41},"line":41,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"641e89ad985f4314b253d99a031c0127","type":"page_info","conversion_output":false,"text":"INDIE-HFpEF Protocol v1.3, 22April2016 (Final)","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[1818,2535],[1865,2535],[1865,2570],[1818,2570]],"region":{"top_left_x":1817,"top_left_y":2535,"width":48,"height":35},"line":42,"column":0,"font_size":22,"is_printed":true,"is_handwritten":false,"id":"ab23ad42c2f84999bf2e97c98e98e1c4","type":"page_info","conversion_output":false,"text":"38","text_display":"","confidence":1,"confidence_rate":1}],"page_height":2750,"page_width":2125,"languages_detected":[]},{"image_id":"2797815c-2843-46aa-81fc-4fe2b5548cd2-39","page":39,"lines":[{"cnt":[[245,303],[1023,303],[1023,357],[245,357]],"region":{"top_left_x":244,"top_left_y":302,"width":779,"height":55},"line":1,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7426383691204339bb04fa382ae744e0","type":"section_header","conversion_output":false,"children_ids":["36dd5e14b644435298147eabdfae92c4"],"text":"","text_display":""},{"cnt":[[249,309],[1016,309],[1016,352],[249,352]],"region":{"top_left_x":249,"top_left_y":309,"width":768,"height":44},"line":2,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"36dd5e14b644435298147eabdfae92c4","type":"text","conversion_output":true,"parent_id":"7426383691204339bb04fa382ae744e0","text":"17.5 Sample Size and Power Calculation","text_display":"\n\n\\subsection*{17.5 Sample Size and Power Calculation}","confidence":1,"confidence_rate":1},{"cnt":[[249,378],[1871,378],[1871,423],[249,423]],"region":{"top_left_x":249,"top_left_y":378,"width":1623,"height":46},"line":3,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1f83b614c0834434b2bf4ba348de9605","type":"text","conversion_output":true,"text":"Peak VO2: From prior HFN studies, the within-patient standard deviation for peak \\(VO _{2}\\) in HFpEF","text_display":"\n\nPeak VO2: From prior HFN studies, the within-patient standard deviation for peak \\(VO _{2}\\) in HFpEF","confidence":0.49561880099607886,"confidence_rate":0.993807323232356},{"cnt":[[247,430],[1766,430],[1766,475],[247,475]],"region":{"top_left_x":247,"top_left_y":429,"width":1520,"height":46},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"532f67dbc6314b4cbc58b7334e015e59","type":"text","conversion_output":true,"text":"is roughly \\(2 ml / min / kg\\).[REF 21] A \\(1.2 ml / min / kg\\) increase in peak \\(VO _{2}\\) is considered to be","text_display":" is roughly \\(2 ml / min / kg\\).[REF 21] A \\(1.2 ml / min / kg\\) increase in peak \\(VO _{2}\\) is considered to be","confidence":0.9561748504638672,"confidence_rate":0.9996526612300376},{"cnt":[[247,481],[1858,481],[1858,526],[247,526]],"region":{"top_left_x":247,"top_left_y":481,"width":1612,"height":46},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"8155469171f14eb3988fd7e0d8ea79a3","type":"text","conversion_output":true,"text":"clinically meaningful for a particular patient. Assuming a \\(2 ml / min / kg\\) standard deviation, a total","text_display":" clinically meaningful for a particular patient. 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These calculations are based on a \\(2 * 2\\) factorial","text_display":" to have a clinically meaningful difference. These calculations are based on a \\(2 * 2\\) factorial","confidence":0.7551152841188014,"confidence_rate":0.9971668004280554},{"cnt":[[245,681],[1858,681],[1858,728],[245,728]],"region":{"top_left_x":244,"top_left_y":681,"width":1615,"height":48},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"853030b9d79d4d0f8c758659f3f894e0","type":"text","conversion_output":true,"text":"design and assume a 2 -sided 0.05 (or 1 -sided 0.025 ) type I error rate. The total sample size of","text_display":" design and assume a 2 -sided 0.05 (or 1 -sided 0.025 ) type I error rate. The total sample size of","confidence":0.9302763612940907,"confidence_rate":0.9993717315798534},{"cnt":[[247,733],[1850,733],[1850,780],[247,780]],"region":{"top_left_x":247,"top_left_y":732,"width":1603,"height":48},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"56887e9c24294a03bb876bb023c6c6bb","type":"text","conversion_output":true,"text":"100 participants allows for approximately \\(10 \\%\\) incomplete data due to missed tests, death, and","text_display":" 100 participants allows for approximately \\(10 \\%\\) incomplete data due to missed tests, death, and","confidence":0.9956073760986328,"confidence_rate":0.9999559779708055},{"cnt":[[245,782],[1794,782],[1794,831],[245,831]],"region":{"top_left_x":244,"top_left_y":782,"width":1550,"height":50},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a5416c2f845470a8e7bf75475c8eb76","type":"text","conversion_output":true,"text":"withdrawal of consent. The sample size estimates were calculated using nQuery and PASS","text_display":" withdrawal of consent. The sample size estimates were calculated using nQuery and PASS","confidence":1,"confidence_rate":1},{"cnt":[[245,834],[406,834],[406,874],[245,874]],"region":{"top_left_x":244,"top_left_y":833,"width":163,"height":42},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"474dcdb9897d4db297c7c7fce0874f34","type":"text","conversion_output":true,"text":"software.","text_display":" software.","confidence":1,"confidence_rate":1},{"cnt":[[266,975],[690,975],[690,1081],[266,1081]],"region":{"top_left_x":266,"top_left_y":975,"width":424,"height":106},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"5e180d56d654403c9886853a2501e6ef","type":"figure_label","conversion_output":false,"children_ids":["90cec303cd2543e0af2f7382814d039e","982c989e8035453f9a6d984ad658f2ec"],"text":"","text_display":""},{"cnt":[[271,980],[660,980],[660,1025],[271,1025]],"region":{"top_left_x":270,"top_left_y":979,"width":390,"height":46},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"90cec303cd2543e0af2f7382814d039e","type":"text","conversion_output":false,"parent_id":"5e180d56d654403c9886853a2501e6ef","text":"Figure 8. Power curve","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[271,1031],[683,1031],[683,1076],[271,1076]],"region":{"top_left_x":270,"top_left_y":1031,"width":414,"height":46},"line":15,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"982c989e8035453f9a6d984ad658f2ec","type":"text","conversion_output":false,"parent_id":"5e180d56d654403c9886853a2501e6ef","text":"for the primary endpoint","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[799,883],[1704,883],[1704,1669],[799,1669]],"region":{"top_left_x":799,"top_left_y":883,"width":905,"height":787},"line":16,"column":0,"font_size":18,"is_printed":true,"is_handwritten":false,"id":"5f0bb2fe015c497e8c25ccc464c542bd","type":"chart","conversion_output":true,"selected_labels":["5e180d56d654403c9886853a2501e6ef"],"text":"","text_display":"\n\n\\begin{figure}\n\\captionsetup{labelformat=empty}\n\\caption{Figure 8. Power curve for the primary endpoint}\n\\includegraphics[alt={},max width=\\textwidth]{https://cdn.mathpix.com/cropped/2797815c-2843-46aa-81fc-4fe2b5548cd2-39.jpg?height=787&width=905&top_left_y=883&top_left_x=799}\n\\end{figure}","subtype":"line"},{"cnt":[[245,1843],[1792,1843],[1792,1893],[245,1893]],"region":{"top_left_x":244,"top_left_y":1843,"width":1548,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"715d2036b9334eb49299649a5f1b6e97","type":"text","conversion_output":true,"text":"KCCQ overall summary score: Clinically significant differences have been established for","text_display":"\n\nKCCQ overall summary score: Clinically significant differences have been established for","confidence":1,"confidence_rate":1},{"cnt":[[245,1893],[1843,1893],[1843,1940],[245,1940]],"region":{"top_left_x":244,"top_left_y":1892,"width":1600,"height":49},"line":18,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f2cf7533f18c4c6fb1b76a133dec66e3","type":"text","conversion_output":true,"text":"these endpoints. From earlier HFN studies, the within-patient standard deviation for the KCCQ","text_display":" these endpoints. From earlier HFN studies, the within-patient standard deviation for the KCCQ","confidence":1,"confidence_rate":1},{"cnt":[[245,1944],[1830,1944],[1830,1992],[245,1992]],"region":{"top_left_x":244,"top_left_y":1944,"width":1587,"height":48},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9a573867455a4ede9eb7e140214a1aa0","type":"text","conversion_output":true,"text":"overall summary score has ranged from 14 to 18 points. In the NEAT study, the within-patient","text_display":" overall summary score has ranged from 14 to 18 points. In the NEAT study, the within-patient","confidence":1,"confidence_rate":1},{"cnt":[[245,1996],[1833,1996],[1833,2043],[245,2043]],"region":{"top_left_x":244,"top_left_y":1995,"width":1589,"height":49},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"1dd7133d24a841ed99b7c2c50959d6be","type":"text","conversion_output":true,"text":"standard deviation for the KCCQ overall summary score was approximately 14 points. For the","text_display":" standard deviation for the KCCQ overall summary score was approximately 14 points. For the","confidence":1,"confidence_rate":1},{"cnt":[[245,2045],[1826,2045],[1826,2093],[245,2093]],"region":{"top_left_x":244,"top_left_y":2045,"width":1583,"height":48},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"9188c739820b4bc4a357f9e43297e936","type":"text","conversion_output":true,"text":"KCCQ, a clinically-significant difference is considered 5 points and a moderately large clinical","text_display":" KCCQ, a clinically-significant difference is considered 5 points and a moderately large clinical","confidence":0.99951171875,"confidence_rate":0.9999953038523912},{"cnt":[[245,2097],[1837,2097],[1837,2142],[245,2142]],"region":{"top_left_x":244,"top_left_y":2096,"width":1593,"height":46},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cc7c11878933400eb95cc3cd743ce14b","type":"text","conversion_output":true,"text":"difference is considered to be 10 points. Assuming a 14 point standard deviation, a total of 70","text_display":" difference is considered to be 10 points. 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Assuming a 16 point standard deviation, a total of","text_display":" points in the KCCQ overall summary score. 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Assuming an 18 point standard deviation, a total","text_display":" 5 points in the KCCQ overall summary score. 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Appendix A - Schedule of Assessments","text_display":"\n\n\\section*{22 Appendix A - Schedule of 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\\multirow{2}{*}{Study Visit Window} & \\multicolumn{11}{|c|}{Phase 1} & \\multicolumn{13}{|c|}{Phase 2} \\\\\n\\hline & Study Visit 1 (-3 to 0) Baseline & Day 4-7 (Washout) & Day 11-14 (Washout) & Day 15 & Day 17 & Day 18-21 & Day 22 & Day 23-24 & Day 25-28 & Day 32-35 & Day 38-41 & Study Visit \\(2{ }^{ + }\\) & Day 4-7 (Washout) & Day 11-14 (Washout) & Day 15 & Day 17 & Day 18-21 & Day 22 & Day 23-24 & Day 25-28 & Day 32-35 & Day 38-41 & Study Visit \\(3^{++}\\) & 2 Week Followup \\({ }^{+++}\\) \\\\\n\\hline Days & 0 & 1-7 & 8-14 & 15-21 & 15-21 & 15-21 & 22-28 & 22-28 & 22-28 & 29-35 & 36-42 & 42-49 & 1-7 & 8-14 & 15-21 & 15-21 & 15-21 & 15-21 & 22-28 & 22-28 & 29-35 & 36-42 & 42-49 & \\\\\n\\hline Study Drug Dose (Nitrite vs Placebo) & & & & 46 mg & 46 mg & 46 mg & 80 mg & 80 mg & 80 mg & 80 mg & 80 mg & 80 mg & & & 46 mg & 46 mg & 46 mg & 80 mg & 80 mg & 80 mg & 80 mg & 80 mg & 80 mg & 14 days Post Visit 3 \\\\\n\\hline Screening (Inclusion/Exclusion) & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Informed Consent* & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Phone Follow-Up & & X & X & & X & X & & X & X & x & X & & X & X & & X & X & & X & X & X & X & & X \\\\\n\\hline Clinical Evaluation & & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Complete Medical History \\({ }^{1}\\) & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Interim Medical History & & X & X & & X & X & & X & X & X & X & X & & & & X & X & & X & X & X & X & X & \\\\\n\\hline Physical Exam & X & & & & & & & & & & & X & & & & & & & & & & & X & \\\\\n\\hline NYHA Class & X & & & & & & & & & & & X & & & & & & & & & & & X & \\\\\n\\hline Medication Review & X & & & & & & & & & & & X & & & & & & & & & & & X & \\\\\n\\hline 12-Lead ECG & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Systolic BP \\({ }^{2}\\) & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Laboratory Evaluation & & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Serum Pregnancy Test & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline CBC & X^^ & & & & & & & & & & & \\(X ^{3}\\) & & & & & & & & & & & \\(X ^{3}\\) & \\\\\n\\hline Complete Chemistry Panel \\({ }^{4}\\) & X^^ & & & & & & & & & & & \\(X ^{3}\\) & & & & & & & & & & & \\(X ^{3}\\) & \\\\\n\\hline Core-Biomarkers \\& Repository & \\(X ^{\\wedge \\wedge}\\) & & & & & & & & & & & \\(X ^{\\wedge 3}\\) & & & & & & & & & & & \\(X ^{\\wedge 3}\\) & \\\\\n\\hline Imaging Evaluation & & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Limited Echo \\({ }^{3}\\) & & & & & & & & & & & & \\(X ^{3}\\) & & & & & & & & & & & \\(X ^{3}\\) & \\\\\n\\hline Exercise Evaluation & & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline CPET \\({ }^{5}\\) & X & & & & & & & & & & & X & & & & & & & & & & & X & \\\\\n\\hline QOL Evaluation & & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline KCCQ & X & & & & & & & & & & & X & & & & & & & & & & & X & \\\\\n\\hline Study Drug and Accelerometer & & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Test Dose ( 80 mg Run-in) \\& BP Observation ( 60 mins ) \\({ }^{6}\\) & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Randomization** & X & & & & & & & & & & & & & & & & & & & & & & & \\\\\n\\hline Dispense/Change out Accelerometer and Instruction & X & & & & & & & & & & & X & & & & & & & & & & & & \\\\\n\\hline Dispense Study Drug, Device and Instructions & X & & & & & & & & & & & X & & & & & & & & & & & & \\\\\n\\hline Return Accelerometer (AXM), Study Drug and Device & & & & & & & & & & & & X & & & & & & & & & & & X & \\\\\n\\hline Study Drug Initiation & & & & 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|l|l|l|l|l|l|l|l|l|}\n\\hline \\multirow{2}{*}{Study Visit Window} & \\multicolumn{11}{|c|}{Phase 1} & \\multicolumn{13}{|c|}{Phase 2} \\\\\n\\hline & Study 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