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Abbreviation/Term & Definition \\\\\n\\hline AE & adverse event \\\\\n\\hline ALP & alkaline phosphatase \\\\\n\\hline ALT & alanine aminotransferase \\\\\n\\hline ANCOVA & analysis of covariance \\\\\n\\hline AST & aspartate aminotransferase \\\\\n\\hline ATC & Anatomical Therapeutic Chemical \\\\\n\\hline BMI & body mass index \\\\\n\\hline C-SSRS & Columbia-Suicide Severity Rating Scale \\\\\n\\hline CFB & change from baseline \\\\\n\\hline CHD & coronary heart disease \\\\\n\\hline CSR & clinical study report \\\\\n\\hline CV & cardiovascular \\\\\n\\hline DBS & dry blood spot \\\\\n\\hline eCRF & electronic case report form \\\\\n\\hline ECG & electrocardiogram, electrocardiographic \\\\\n\\hline EQ VAS & European Quality of Life Visual Analogue Scale \\\\\n\\hline EQ-5D-5L & European Quality of Life 5 Dimensional - 5 Level \\\\\n\\hline EU & European Union \\\\\n\\hline FDS & Functional Disability Scale \\\\\n\\hline FWER & familywise error rate \\\\\n\\hline HEOR & Health Economics and Outcomes Research \\\\\n\\hline HR & hazard ratio \\\\\n\\hline INR & international normalized ratio \\\\\n\\hline IP & investigational product \\\\\n\\hline IWRS & interactive web response system \\\\\n\\hline kg & kilogram(s) \\\\\n\\hline KM & Kaplan-Meier \\\\\n\\hline LOCF & last observation carried forward \\\\\n\\hline LS & least squares \\\\\n\\hline m & meter(s) \\\\\n\\hline MedDRA & Medication Dictionary for Regulatory Activities \\\\\n\\hline mITT & modified intent-to-treat \\\\\n\\hline PCS & potentially clinically significant \\\\\n\\hline PF & pain free \\\\\n\\hline PGIC & Participant Global Impression of Change \\\\\n\\hline & \\\\\n\\hline PO & Primary Objective \\\\\n\\hline PR & pain relief \\\\\n\\hline PT & preferred term \\\\\n\\hline QTc & QT interval corrected for heart rate \\\\\n\\hline QTcB & QT interval corrected for heart rate using the Bazett formula ( \\(QTcB = QT /( RR )^{1 / 2}\\) ) \\\\\n\\hline QTcF & QT interval corrected for heart 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Quality of Life Visual Analogue Scale \\\\\n\\hline EQ-5D-5L & European Quality of Life 5 Dimensional - 5 Level \\\\\n\\hline EU & European Union \\\\\n\\hline FDS & Functional Disability Scale \\\\\n\\hline FWER & familywise error rate \\\\\n\\hline HEOR & Health Economics and Outcomes Research \\\\\n\\hline HR & hazard ratio \\\\\n\\hline INR & international normalized ratio \\\\\n\\hline IP & investigational product \\\\\n\\hline IWRS & interactive web response system \\\\\n\\hline kg & kilogram(s) \\\\\n\\hline KM & Kaplan-Meier \\\\\n\\hline LOCF & last observation carried forward \\\\\n\\hline LS & least squares \\\\\n\\hline m & meter(s) \\\\\n\\hline MedDRA & Medication Dictionary for Regulatory Activities \\\\\n\\hline mITT & modified intent-to-treat \\\\\n\\hline PCS & potentially clinically significant \\\\\n\\hline PF & pain free \\\\\n\\hline PGIC & Participant Global Impression of Change \\\\\n\\hline & \\\\\n\\hline PO & Primary Objective \\\\\n\\hline PR & pain relief 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Endpoints}","confidence":0.9951171875,"confidence_rate":0.9998745008916533},{"cnt":[[245,404],[1463,404],[1463,453],[245,453]],"region":{"top_left_x":244,"top_left_y":403,"width":1220,"height":51},"line":5,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"451c1bbce0f540f4a9cef5d586cb3009","type":"text","conversion_output":true,"text":"Each study objective is presented with corresponding endpoint(s) below:","text_display":"\n\nEach study objective is presented with corresponding endpoint(s) below:","confidence":1,"confidence_rate":1},{"cnt":[[245,505],[1214,505],[1214,548],[245,548]],"region":{"top_left_x":244,"top_left_y":504,"width":970,"height":44},"line":6,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cabcf65f03b64f88a11d24c98d85df83","type":"figure_label","conversion_output":false,"text":"Table 4-1 Study Objectives and Corresponding Endpoints","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[223,559],[1901,559],[1901,2458],[223,2458]],"region":{"top_left_x":223,"top_left_y":558,"width":1679,"height":1900},"line":7,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"11cd984ce4a44752b26243686b3344f7","type":"table","conversion_output":true,"children_ids":["50a7f31589d145c9910eb53adc08d9c7","32c58a85c4064d06a469d5a0e02ed25c","f28cfe0b03a045b7a80aa3fceecf5b97","ae47b28c8a004304bca000bd085f5fa3","4a118472a8734588a1c0abd8460b7683","cee2c80df7b04e0a91b184975f56ca24","57131ad4d74f4cd7818d023a3d5dffcd","e435087d15f34f5488b2144254d18954"],"selected_labels":["cabcf65f03b64f88a11d24c98d85df83"],"text":"\\begin{tabular}{|l|l|}\n\\hline Objectives & Endpoints \\\\\n\\hline \\begin{tabular}{l}\nPrimary \\\\\n- [PO1] To compare the efficacy, safety, and tolerability of 2 doses of ubrogepant ( 25 and 50 mg ) with placebo in participants with a single migraine attack\n\\end{tabular} & \\begin{tabular}{l}\nPrimary Efficacy Endpoints \\\\\nThe coprimary efficacy parameters for the United States of America (US) are as follows: \\\\\n- [P1] Pain freedom (PF) at 2 hours after the initial dose, defined as a reduction in headache severity from moderate/severe at baseline to no pain, at 2 hours after the initial dose \\\\\n- [P2] Absence of the most bothersome migraine-associated symptom (the most bothersome migraine-associated symptom will be identified at baseline for each participant) at 2 hours after the initial dose.![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-010.jpg?height=233\\&width=855\\&top_left_y=1485\\&top_left_x=995) \\\\\nSecondary Efficacy Endpoints \\\\\nThe secondary efficacy parameters for the US are: \\\\\n- [S1] Pain relief (PR) at 2 hours after the initial dose, defined as the reduction of a moderate/severe migraine headache to a mild headache or to no headache, at 2 hours after the initial dose \\\\\n- [S2] Sustained pain relief (SPR) from 2 to 24 hours after the initial dose, defined as pain relief with no administration of either rescue medication or the second dose of IP, and with\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 4-1 Study Objectives and Corresponding Endpoints}\n\\begin{tabular}{|l|l|}\n\\hline Objectives & Endpoints \\\\\n\\hline \\begin{tabular}{l}\nPrimary \\\\\n- [PO1] To compare the efficacy, safety, and tolerability of 2 doses of ubrogepant ( 25 and 50 mg ) with placebo in participants with a single migraine attack\n\\end{tabular} & \\begin{tabular}{l}\nPrimary Efficacy Endpoints \\\\\nThe coprimary efficacy parameters for the United States of America (US) are as follows: \\\\\n- [P1] Pain freedom (PF) at 2 hours after the initial dose, defined as a reduction in headache severity from moderate/severe at baseline to no pain, at 2 hours after the initial dose \\\\\n- [P2] Absence of the most bothersome migraine-associated symptom (the most bothersome migraine-associated symptom will be identified at baseline for each participant) at 2 hours after the initial dose.![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-010.jpg?height=233\\&width=855\\&top_left_y=1485\\&top_left_x=995) \\\\\nSecondary Efficacy Endpoints \\\\\nThe secondary efficacy parameters for the US are: \\\\\n- [S1] Pain relief (PR) at 2 hours after the initial dose, defined as the reduction of a moderate/severe migraine headache to a mild headache or to no headache, at 2 hours after the initial dose \\\\\n- [S2] Sustained pain relief (SPR) from 2 to 24 hours after the initial dose, defined as pain relief with no administration of either rescue medication or the second dose of IP, and with\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.9980475902557373,"confidence_rate":0.9999995265703202},{"cnt":[[231,558],[973,558],[973,2451],[231,2451]],"region":{"top_left_x":231,"top_left_y":558,"width":743,"height":1894},"line":8,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"50a7f31589d145c9910eb53adc08d9c7","type":"table_column","conversion_output":false,"parent_id":"11cd984ce4a44752b26243686b3344f7","text":"","text_display":""},{"cnt":[[990,558],[1887,558],[1887,2451],[990,2451]],"region":{"top_left_x":989,"top_left_y":558,"width":899,"height":1894},"line":9,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"32c58a85c4064d06a469d5a0e02ed25c","type":"table_column","conversion_output":false,"parent_id":"11cd984ce4a44752b26243686b3344f7","text":"","text_display":""},{"cnt":[[223,572],[1901,572],[1901,632],[223,632]],"region":{"top_left_x":223,"top_left_y":571,"width":1678,"height":61},"line":10,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f28cfe0b03a045b7a80aa3fceecf5b97","type":"table_row","conversion_output":false,"parent_id":"11cd984ce4a44752b26243686b3344f7","text":"","text_display":""},{"cnt":[[223,640],[1898,640],[1898,2449],[223,2449]],"region":{"top_left_x":223,"top_left_y":639,"width":1676,"height":1810},"line":11,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"ae47b28c8a004304bca000bd085f5fa3","type":"table_row","conversion_output":false,"parent_id":"11cd984ce4a44752b26243686b3344f7","text":"","text_display":""},{"cnt":[[509,580],[706,580],[706,626],[509,626]],"region":{"top_left_x":509,"top_left_y":579,"width":197,"height":48},"line":12,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"4a118472a8734588a1c0abd8460b7683","type":"simple_cell","conversion_output":false,"parent_id":"11cd984ce4a44752b26243686b3344f7","text":"Objectives","text_display":"Objectives","cell_row":0,"cell_column":0,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[1342,580],[1535,580],[1535,626],[1342,626]],"region":{"top_left_x":1341,"top_left_y":579,"width":195,"height":48},"line":13,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cee2c80df7b04e0a91b184975f56ca24","type":"simple_cell","conversion_output":false,"parent_id":"11cd984ce4a44752b26243686b3344f7","text":"Endpoints","text_display":"Endpoints","cell_row":0,"cell_column":1,"cell_row_span":1,"cell_col_span":1,"confidence":1,"confidence_rate":1},{"cnt":[[242,645],[962,645],[962,959],[242,959]],"region":{"top_left_x":242,"top_left_y":645,"width":721,"height":315},"line":14,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"57131ad4d74f4cd7818d023a3d5dffcd","type":"complex_cell","conversion_output":false,"parent_id":"11cd984ce4a44752b26243686b3344f7","children_ids":["989aca29feca42b3b74ab4b8a3ca7e19","1c98627dd3624f2e9e74e79106cd0481","9ff77d6238bd49609a980b61a8838dd2","148758a315404dcc8072adba4de11568","5870a104eba04fbcb6430dc7ba7f7aed","46673fe9d56a4eccad22860786b5a1c4"],"text":"\\begin{tabular}{l}\nPrimary \\\\\n- [PO1] To compare the efficacy, safety, and tolerability of 2 doses of ubrogepant ( 25 and 50 mg ) with placebo in participants with a single migraine attack\n\\end{tabular}","text_display":"\\begin{tabular}{l}\nPrimary \\\\\n- [PO1] To compare the efficacy, safety, and tolerability of 2 doses of ubrogepant ( 25 and 50 mg ) with placebo in participants with a single migraine 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Efficacy Endpoints \\\\\nThe coprimary efficacy parameters for the United States of America (US) are as follows: \\\\\n- [P1] Pain freedom (PF) at 2 hours after the initial dose, defined as a reduction in headache severity from moderate/severe at baseline to no pain, at 2 hours after the initial dose \\\\\n- [P2] Absence of the most bothersome migraine-associated symptom (the most bothersome migraine-associated symptom will be identified at baseline for each participant) at 2 hours after the initial dose.![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-010.jpg?height=233\\&width=855\\&top_left_y=1485\\&top_left_x=995) \\\\\nSecondary Efficacy Endpoints \\\\\nThe secondary efficacy parameters for the US are: \\\\\n- [S1] Pain relief (PR) at 2 hours after the initial dose, defined as the reduction of a moderate/severe migraine headache to a mild headache or to no headache, at 2 hours after the initial dose \\\\\n- [S2] Sustained pain relief (SPR) from 2 to 24 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Placebo","confidence":1,"confidence_rate":1},{"cnt":[[296,2071],[679,2071],[679,2118],[296,2118]],"region":{"top_left_x":296,"top_left_y":2071,"width":383,"height":48},"line":58,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2377634244f3423e9262e5acbf7f63f0","type":"text","conversion_output":true,"text":"- Ubrogepant 25 mg","text_display":"\n- Ubrogepant 25 mg","confidence":1,"confidence_rate":1},{"cnt":[[296,2155],[681,2155],[681,2202],[296,2202]],"region":{"top_left_x":296,"top_left_y":2154,"width":386,"height":49},"line":59,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"f34e9760e85849ee8595dcf1d7b586e2","type":"text","conversion_output":true,"text":"- Ubrogepant 50 mg","text_display":"\n- Ubrogepant 50 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All confidence intervals will be 2 -sided \\(95 \\%\\) confidence intervals, unless stated","text_display":"\nmain effects. All confidence intervals will be 2 -sided \\(95 \\%\\) confidence intervals, unless stated","confidence":0.9990236759185791,"confidence_rate":0.9999907849387211},{"cnt":[[245,314],[423,314],[423,354],[245,354]],"region":{"top_left_x":244,"top_left_y":313,"width":180,"height":42},"line":4,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"81026766ae644c0c868c1288459f962a","type":"text","conversion_output":true,"text":"otherwise.","text_display":" otherwise.","confidence":1,"confidence_rate":1},{"cnt":[[245,412],[965,412],[965,458],[245,458]],"region":{"top_left_x":244,"top_left_y":412,"width":721,"height":46},"line":5,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"86d02a085a1f478fbd0767dab5646ccd","type":"figure_label","conversion_output":false,"text":"Table 5-2 Statistical 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& Methodology & Description \\\\\n\\hline M1 & Categorical counts & \\begin{tabular}{l}\n- Number of participants in individual categories \\\\\n- Participants with \\(\\geq 1\\) qualifying event counted once per individual category\n\\end{tabular} \\\\\n\\hline M2 & Categorical descriptives & \\begin{tabular}{l}\n- Number and percentage of participants in individual categories \\\\\n- Participants with \\(\\geq 1\\) qualifying event counted once per individual category \\\\\n- N1 if proportion denominator \\(\\neq\\) number of participants in the population (standard percentage denominator) \\\\\n- N1 = participants with non-missing baseline value\n\\end{tabular} \\\\\n\\hline & & ![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-020.jpg?height=250\\&width=1298\\&top_left_y=803\\&top_left_x=614) \\\\\n\\hline & & \\\\\n\\hline M5 & Continuous descriptives & \\begin{tabular}{l}\n- N1, mean, standard deviation (SD), median, minimum, maximum \\\\\n- N1 = participants with non-missing value\n\\end{tabular} \\\\\n\\hline M6 & CFB descriptives & \\begin{tabular}{l}\n- Continuous descriptives for baseline, postbaseline, and change from baseline (CFB) values \\\\\n- N1 = participants with non-missing values at both baseline and the specified postbaseline analysis visit\n\\end{tabular} \\\\\n\\hline & & ![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-020.jpg?height=413\\&width=1281\\&top_left_y=1511\\&top_left_x=614) \\\\\n\\hline M8 & Responder & \\begin{tabular}{l}\n- Categorical descriptives using proportions for responders and nonresponders \\\\\n- Nonresponders include: \\\\\n- Participants who do not meet responder criteria \\\\\n- N1 = all participants unless otherwise specified\n\\end{tabular} \\\\\n\\hline & & ![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-020.jpg?height=94\\&width=1207\\&top_left_y=2085\\&top_left_x=618) \\\\\n\\hline M10 & Logistic regression model & \\begin{tabular}{l}\n- Measures the relationship between the binary categorical dependent variable (responder or nonresponder) and independent variables \\\\\n- Independent variables for initial dose: \\\\\n- treatment group (placebo, ubrogepant 25 mg , ubrogepant 50 mg ) \\\\\n- historical triptan response (triptan responder, triptan insufficient responder, or triptan naïve) \\\\\n- use of medication for migraine prevention (yes, no) \\\\\n- baseline headache severity (moderate or severe)\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 5-2 Statistical Methodology}\n\\begin{tabular}{|l|l|l|}\n\\hline & Methodology & Description \\\\\n\\hline M1 & Categorical counts & \\begin{tabular}{l}\n- Number of participants in individual categories \\\\\n- Participants with \\(\\geq 1\\) qualifying event counted once per individual category\n\\end{tabular} \\\\\n\\hline M2 & Categorical descriptives & \\begin{tabular}{l}\n- Number and percentage of participants in individual categories \\\\\n- Participants with \\(\\geq 1\\) qualifying event counted once per individual category \\\\\n- N1 if proportion denominator \\(\\neq\\) number of participants in the population (standard percentage denominator) \\\\\n- N1 = participants with non-missing baseline value\n\\end{tabular} \\\\\n\\hline & & ![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-020.jpg?height=250\\&width=1298\\&top_left_y=803\\&top_left_x=614) \\\\\n\\hline & & \\\\\n\\hline M5 & Continuous descriptives & \\begin{tabular}{l}\n- N1, mean, standard deviation (SD), median, minimum, maximum \\\\\n- N1 = participants with non-missing value\n\\end{tabular} \\\\\n\\hline M6 & CFB descriptives & \\begin{tabular}{l}\n- Continuous descriptives for baseline, postbaseline, and change from baseline (CFB) values \\\\\n- N1 = participants with non-missing values at both baseline and the specified postbaseline analysis visit\n\\end{tabular} \\\\\n\\hline & & ![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-020.jpg?height=413\\&width=1281\\&top_left_y=1511\\&top_left_x=614) \\\\\n\\hline M8 & Responder & \\begin{tabular}{l}\n- Categorical descriptives using proportions for responders and nonresponders \\\\\n- Nonresponders include: \\\\\n- Participants who do not meet responder criteria \\\\\n- N1 = all participants unless otherwise specified\n\\end{tabular} \\\\\n\\hline & & ![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-020.jpg?height=94\\&width=1207\\&top_left_y=2085\\&top_left_x=618) \\\\\n\\hline M10 & Logistic regression model & \\begin{tabular}{l}\n- Measures the relationship between the binary categorical dependent variable (responder or nonresponder) and independent variables \\\\\n- Independent variables for initial dose: \\\\\n- treatment group (placebo, ubrogepant 25 mg , ubrogepant 50 mg ) \\\\\n- historical triptan response 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Protocol deviations will be summarized as follows:","confidence":0.99951171875,"confidence_rate":0.9999940439141021},{"cnt":[[245,503],[1046,503],[1046,548],[245,548]],"region":{"top_left_x":244,"top_left_y":502,"width":803,"height":46},"line":7,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cc2058b9620d4eceafc2266d30063c93","type":"figure_label","conversion_output":false,"text":"Table 5-6 Protocol Deviation Summary","text_display":"","confidence":1,"confidence_rate":1},{"cnt":[[226,559],[1897,559],[1897,692],[226,692]],"region":{"top_left_x":225,"top_left_y":558,"width":1673,"height":134},"line":8,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"cb081a8e36604ceaa1c9a11e3c8f47d6","type":"table","conversion_output":true,"selected_labels":["cc2058b9620d4eceafc2266d30063c93"],"text":"\\begin{tabular}{|l|l|c|c|}\n\\hline Parameter & \\multicolumn{1}{|c|}{ Description } & Timing & Methodology \\\\\n\\hline \\begin{tabular}{l} \nMajor protocol \\\\\ndeviations \\(^{1}\\)\n\\end{tabular} & \\begin{tabular}{l} \nDistribution in the ITT Population in total \\\\\nand by treatment group\n\\end{tabular} & - & \\begin{tabular}{l} \nCategorical \\\\\ndescriptives\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 5-6 Protocol Deviation Summary}\n\\begin{tabular}{|l|l|c|c|}\n\\hline Parameter & \\multicolumn{1}{|c|}{ Description } & Timing & Methodology \\\\\n\\hline \\begin{tabular}{l} \nMajor protocol \\\\\ndeviations \\(^{1}\\)\n\\end{tabular} & \\begin{tabular}{l} \nDistribution in the ITT Population in total \\\\\nand by treatment group\n\\end{tabular} & - & \\begin{tabular}{l} \nCategorical \\\\\ndescriptives\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.7904735554083864,"confidence_rate":0.9991867562050832},{"cnt":[[262,687],[735,687],[735,724],[262,724]],"region":{"top_left_x":262,"top_left_y":687,"width":473,"height":38},"line":9,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"7b73610262ef4c91b53e3566bc9e5953","type":"text","conversion_output":true,"text":"Protocol deviations will be listed.","text_display":"\n\nProtocol deviations will be 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Unique participants who report medical history events will be","text_display":" (MedDRA), version 19.0 or newer. Unique participants who report medical history events will be","confidence":1,"confidence_rate":1},{"cnt":[[245,1283],[1781,1283],[1781,1334],[245,1334]],"region":{"top_left_x":244,"top_left_y":1282,"width":1538,"height":53},"line":50,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"c5c377dbe85f44799124805223c34249","type":"text","conversion_output":true,"text":"summarized by MedDRA system organ class (SOC) and preferred term (PT) in total and by","text_display":" summarized by MedDRA system organ class (SOC) and preferred term (PT) in total and by","confidence":1,"confidence_rate":1},{"cnt":[[245,1345],[1137,1345],[1137,1394],[245,1394]],"region":{"top_left_x":244,"top_left_y":1344,"width":893,"height":51},"line":51,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"d6f51aaa52b24cd7a3e53c8b34628189","type":"text","conversion_output":true,"text":"treatment group for the Safety Population as follows:","text_display":" treatment group for the 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surgeries occurring \\\\\nbefore the Screening Visit\n\\end{tabular} & Screening Period & \\begin{tabular}{l} \nCategorical \\\\\ndescriptives\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 5-9 Medical History Summary}\n\\begin{tabular}{|l|l|c|c|}\n\\hline Parameter & \\multicolumn{1}{|c|}{ Description } & Timing & Methodology \\\\\n\\hline Medical history \\(^{1}\\) & \\begin{tabular}{l} \nAbnormalities and surgeries occurring \\\\\nbefore the Screening Visit\n\\end{tabular} & Screening Period & \\begin{tabular}{l} \nCategorical \\\\\ndescriptives\n\\end{tabular} \\\\\n\\hline\n\\end{tabular}\n\\end{table}","confidence":0.8736359988054119,"confidence_rate":0.9995227589072356},{"cnt":[[245,1629],[1721,1629],[1721,1674],[245,1674]],"region":{"top_left_x":244,"top_left_y":1628,"width":1477,"height":46},"line":54,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"c1db3e64f3f64bf18d2d81bf6c917294","type":"text","conversion_output":true,"text":"SOCs will be sorted alphabetically; PTs will be sorted in descending frequency in the highest dose group.","text_display":"\n\nSOCs will be sorted alphabetically; PTs will be sorted in descending frequency in the highest dose group.","confidence":1,"confidence_rate":1},{"cnt":[[249,1663],[840,1663],[840,1712],[249,1712]],"region":{"top_left_x":249,"top_left_y":1662,"width":592,"height":51},"line":55,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"19b692fee7a44747934e14b093ff7fe2","type":"text","conversion_output":true,"text":"\\({ }^{1}\\) Participant medical 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Assessment/Term & Description \\\\\n\\hline Rating of Headache Severity \\({ }^{1}\\) & \\begin{tabular}{l}\nHeadache severity will be subjectively rated by the participant at predefined timepoints (predose and \\(0.5,1,1.5,2,3,4,6,8,24\\), and 48 hours after the initial dose) on a scale from no pain to severe pain: \\\\\n- No pain \\\\\n- Mild pain \\\\\n- Moderate pain \\\\\n- Severe pain\n\\end{tabular} \\\\\n\\hline Use of Rescue Medication \\({ }^{1}\\) & \\begin{tabular}{l}\nAny rescue medication taken within 48 hours after treating their migraine attack with IP, in addition documenting the date and time that the rescue medication was taken. \\\\\n- Recorded by participants in e-diary\n\\end{tabular} \\\\\n\\hline Use of Optional Second Dose and Recurrence of Headache Pain \\({ }^{1}\\) & \\begin{tabular}{l}\nOptional second dose of IP due to inadequate response to their initial dose of IP. Date and time of the second dose will be reported, as well as pain severity and absence or presence of migraine-associated symptoms at the time the second dose is taken and 2 hours after taking the second dose. The incidence of recurrence in participants who had pain relief and pain freedom at 2 hours after the initial dose will be collected. \\\\\n- Recorded by participants in e-diary\n\\end{tabular} \\\\\n\\hline Migraine-associated symptoms \\({ }^{1}\\) & \\begin{tabular}{l}\nAbsence or presence of migraine-associated symptoms: photophobia, phonophobia, nausea, and vomiting \\\\\n- Completed by the participant in e-diary\n\\end{tabular} \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline \\multicolumn{2}{|c|}{} \\\\\n\\hline & ![](https://cdn.mathpix.com/cropped/55c98739-8bd1-44fb-9a8b-849b10eff7ea-036.jpg?height=247\\&width=1202\\&top_left_y=1975\\&top_left_x=678) \\\\\n\\hline & \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{Table 5-12 Efficacy Assessments}\n\\begin{tabular}{|l|l|}\n\\hline Assessment/Term & Description \\\\\n\\hline Rating of Headache Severity \\({ }^{1}\\) & \\begin{tabular}{l}\nHeadache severity will be subjectively rated by the participant at predefined timepoints (predose and \\(0.5,1,1.5,2,3,4,6,8,24\\), and 48 hours after the initial dose) on a scale from no pain to severe pain: \\\\\n- No pain \\\\\n- Mild pain \\\\\n- Moderate pain \\\\\n- Severe pain\n\\end{tabular} \\\\\n\\hline Use of Rescue Medication \\({ }^{1}\\) & \\begin{tabular}{l}\nAny rescue medication taken within 48 hours after treating their migraine attack with IP, in addition documenting the date and time that the rescue medication was taken. \\\\\n- Recorded by participants in e-diary\n\\end{tabular} \\\\\n\\hline Use of Optional Second Dose and Recurrence of Headache Pain \\({ }^{1}\\) & \\begin{tabular}{l}\nOptional second dose of IP due to inadequate response to their initial dose of IP. 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Endpoints for US","text_display":"\n\n\\subsection*{5.1.1.3.1 Endpoints for US}","confidence":1,"confidence_rate":1},{"cnt":[[247,902],[1558,902],[1558,950],[247,950]],"region":{"top_left_x":247,"top_left_y":902,"width":1311,"height":48},"line":32,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"7fe98e6648884ef0ac7139253e7a37c7","type":"text","conversion_output":true,"text":"The efficacy endpoints for the United States analyses are described as follows.","text_display":"\n\nThe efficacy endpoints for the United States analyses are described as follows.","confidence":1,"confidence_rate":1},{"cnt":[[245,1126],[393,1126],[393,1158],[245,1158]],"region":{"top_left_x":244,"top_left_y":1125,"width":150,"height":34},"line":33,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"28ab5c2dd62b4eb0bebb7eb31eb55717","type":"figure_label","conversion_output":true,"text":"Table 5-14","text_display":"\n\nTable 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Endpoint & Description & Timing & Methodology \\\\\n\\hline P1 & Pain freedom (PF) at 2 hours after the initial dose, defined as a reduction in headache severity from moderate/severe at baseline to no pain, at 2 hours after the initial dose & 2 hours after the initial dose & Logistic regression model \\\\\n\\hline P2 & Absence of the most bothersome migraine-associated symptom (the most bothersome migraine-associated symptom will be identified at baseline for each participant) at 2 hours after the initial dose. & 2 hours after the initial dose & Logistic regression model \\\\\n\\hline S1 & Pain relief (PR) at 2 hours after the initial dose, defined as the reduction of a moderate/severe migraine headache to a mild headache or to no headache, at 2 hours after the initial dose & 2 hours after the initial dose & Logistic regression model \\\\\n\\hline S2 & Sustained pain relief (SPR) from 2 to 24 hours after the initial dose, defined as pain relief with no administration of either rescue 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Logistic regression model \\\\\n\\hline\n\\end{tabular}","text_display":"\n\n\\begin{table}\n\\captionsetup{labelformat=empty}\n\\caption{US Analyses}\n\\begin{tabular}{|l|l|l|l|}\n\\hline Endpoint & Description & Timing & Methodology \\\\\n\\hline P1 & Pain freedom (PF) at 2 hours after the initial dose, defined as a reduction in headache severity from moderate/severe at baseline to no pain, at 2 hours after the initial dose & 2 hours after the initial dose & Logistic regression model \\\\\n\\hline P2 & Absence of the most bothersome migraine-associated symptom (the most bothersome migraine-associated symptom will be identified at baseline for each participant) at 2 hours after the initial dose. & 2 hours after the initial dose & Logistic regression model \\\\\n\\hline S1 & Pain relief (PR) at 2 hours after the initial dose, defined as the reduction of a moderate/severe migraine headache to a mild headache or to no headache, at 2 hours after the initial dose & 2 hours after the initial dose & Logistic regression model \\\\\n\\hline S2 & Sustained pain relief (SPR) from 2 to 24 hours after the initial dose, defined as pain relief with no administration of either rescue medication or the second dose of IP, and with no occurrence thereafter of a moderate/severe headache during the relevant number of hours after dosing with the IP & 2 to 24 hours after the initial dose & Logistic regression model \\\\\n\\hline S3 & Sustained pain freedom (SPF) from 2 to 24 hours after the initial dose, defined as pain freedom with no administration of either rescue medication or the second dose of IP, and with no occurrence thereafter of a mild/moderate/severe headache during the relevant number of hours after dosing with the IP & 2 to 24 hours after the initial dose & Logistic regression model \\\\\n\\hline S4a & Absence of photophobia at 2 hours after the initial dose & 2 hours after the initial dose & Logistic regression model \\\\\n\\hline S4b & Absence of phonophobia at 2 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For the US analyses, the coprimary efficacy endpoints will serve as the gatekeepers of","confidence":1,"confidence_rate":1},{"cnt":[[245,1306],[664,1306],[664,1356],[245,1356]],"region":{"top_left_x":244,"top_left_y":1306,"width":420,"height":50},"line":17,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"53c1c429a7934733b7cd18a45277bdd7","type":"text","conversion_output":true,"text":"the secondary endpoints.","text_display":" the secondary endpoints.","confidence":1,"confidence_rate":1},{"cnt":[[245,1362],[956,1362],[956,1420],[245,1420]],"region":{"top_left_x":244,"top_left_y":1362,"width":713,"height":59},"line":18,"column":0,"font_size":28,"is_printed":true,"is_handwritten":false,"id":"8f7cd819a4024d46a14d6a82d3675b49","type":"form_field","conversion_output":true,"text":"","text_display":"\n□","subtype":"box"},{"cnt":[[954,1366],[1824,1366],[1824,1416],[954,1416]],"region":{"top_left_x":953,"top_left_y":1366,"width":872,"height":50},"line":19,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"cf1ac161295b4c1f95a7eeae890b5c82","type":"text","conversion_output":true,"text":"The secondary endpoints will be tested in the same","text_display":" The secondary endpoints will be tested in the same","confidence":0.898486852645874,"confidence_rate":0.9980556525985546},{"cnt":[[245,1427],[1777,1427],[1777,1476],[245,1476]],"region":{"top_left_x":244,"top_left_y":1426,"width":1533,"height":50},"line":20,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"320168342ed0408cab83ee1dd96cd86e","type":"text","conversion_output":true,"text":"order as they appear in the list of secondary endpoints, except for the 2 migraine-associated","text_display":" order as they appear in the list of secondary endpoints, except for the 2 migraine-associated","confidence":0.99951171875,"confidence_rate":0.9999951643631956},{"cnt":[[245,1487],[1820,1487],[1820,1536],[245,1536]],"region":{"top_left_x":244,"top_left_y":1486,"width":1576,"height":51},"line":21,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"feabb89059dd4d218cd9af924e17ce9a","type":"text","conversion_output":true,"text":"symptoms, photophobia and phonophobia, which will be treated at the same level to allow the","text_display":" symptoms, photophobia and phonophobia, which will be treated at the same level to allow the","confidence":1,"confidence_rate":1},{"cnt":[[245,1547],[1867,1547],[1867,1596],[245,1596]],"region":{"top_left_x":244,"top_left_y":1546,"width":1623,"height":51},"line":22,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"46d312af73224cbfb98005467358d580","type":"text","conversion_output":true,"text":"recycling of weights among the 2 symptom endpoints. Recycling of weights between the 2 doses","text_display":" recycling of weights among the 2 symptom endpoints. 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The weight is the","text_display":" endpoints are represented by circles with associated weights inside the circle. The weight is the","confidence":1,"confidence_rate":1},{"cnt":[[245,1826],[1867,1826],[1867,1876],[245,1876]],"region":{"top_left_x":244,"top_left_y":1826,"width":1623,"height":50},"line":26,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"733a77b0510e4a068f2cc9bdb3e32064","type":"text","conversion_output":true,"text":"fraction of \\(\\alpha\\), representing local significance levels. The fraction in the rectangle, associated with","text_display":" fraction of \\(\\alpha\\), representing local significance levels. 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the line which is added to the local significance level of the circle at the end of","text_display":" the beginning of the line which is added to the local significance level of the circle at the end of","confidence":1,"confidence_rate":1},{"cnt":[[245,2007],[1319,2007],[1319,2056],[245,2056]],"region":{"top_left_x":244,"top_left_y":2006,"width":1076,"height":51},"line":29,"column":0,"font_size":35,"is_printed":true,"is_handwritten":false,"id":"2810618387514c448995db95478a8cdf","type":"text","conversion_output":true,"text":"the line, if the null hypothesis at the beginning circle is rejected.","text_display":" the line, if the null hypothesis at the beginning circle is 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Circle & Alternative Hypothesis & Objective & Weight & Local Significance Level \\\\\n\\hline 25 mgP 1 & Primary Efficacy Endpoint 1 for 25 mg ubrogepant is significantly different from placebo & PO1 & 1/2 & \\(\\alpha^{*}(1 / 2)=\\alpha / 2\\) \\\\\n\\hline 25 mgP 2 & Primary Efficacy Endpoint 2 for 25 mg ubrogepant is significantly different from placebo & PO1 & 0 & \\(\\alpha^{*} 0=0\\) \\\\\n\\hline 25 mgS 3 & Secondary Efficacy Endpoint 1 for 25 mg ubrogepant is significantly different from placebo & PO1 & 0 & \\(\\alpha^{*} 0=0\\) \\\\\n\\hline 25 mgS 1 & Secondary Efficacy Endpoint 2 for 25 mg ubrogepant is significantly different from placebo & PO1 & 0 & \\(\\alpha^{*} 0=0\\) \\\\\n\\hline 25 mgS 2 & Secondary Efficacy Endpoint 3 for 25 mg ubrogepant is significantly different from placebo & PO1 & 0 & \\(\\alpha^{*} 0=0\\) \\\\\n\\hline 25 mgS 4 a & Secondary Efficacy Endpoint 4a for 25 mg ubrogepant is significantly different from placebo & PO1 & 0 & \\(\\alpha^{*} 0=0\\) 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