<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04418765</url>
  </required_header>
  <id_info>
    <org_study_id>18898A</org_study_id>
    <nct_id>NCT04418765</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments</brief_title>
  <acronym>DELIVER</acronym>
  <official_title>Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With an Extension Period to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>H. Lundbeck A/S</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful&#xD;
      prior preventive treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total study duration from the screening visit to the completion visit is approximately 76&#xD;
      weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24&#xD;
      weeks) and a treatment extension period (48 weeks).&#xD;
&#xD;
      The participant will start treatment at the baseline visit and follow a 12-week dosing&#xD;
      schedule with either eptinezumab (100 or 300 milligrams [mg]) or placebo by intraveneous (IV)&#xD;
      infusion. Participants who were assigned to placebo in the placebo-controlled treatment&#xD;
      period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or&#xD;
      eptinezumab 100 mg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">September 15, 2022</completion_date>
  <primary_completion_date type="Actual">July 15, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline, Weeks 1 - 12</time_frame>
    <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline to Weeks 1 - 12</time_frame>
    <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24</measure>
    <time_frame>Baseline, Weeks 13 - 24</time_frame>
    <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline to Weeks 1 - 12</time_frame>
    <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24</measure>
    <time_frame>Baseline to Weeks 13 - 24</time_frame>
    <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24</measure>
    <time_frame>Baseline to Weeks 13 - 24</time_frame>
    <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline to Weeks 1 - 12</time_frame>
    <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline to Weeks 1 - 12</time_frame>
    <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline to Weeks 1 - 12</time_frame>
    <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline to Weeks 1 - 12</time_frame>
    <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline, Weeks 1 - 12</time_frame>
    <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline, Weeks 1 - 12</time_frame>
    <description>A migraine attack was defined as a headache that occurred on a single day or lasted &gt;1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline, Weeks 1 - 12</time_frame>
    <description>A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline, Weeks 1 - 12</time_frame>
    <description>In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24</measure>
    <time_frame>Baseline, Weeks 13- 24</time_frame>
    <description>In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline, Weeks 1 - 12</time_frame>
    <description>Number of MMDs with acute medication usage was derived using the answer to &quot;Did you take any medications to treat this headache?&quot; in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as &quot;Yes&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24</measure>
    <time_frame>Baseline, Weeks 13 - 24</time_frame>
    <description>Number of MMDs with acute medication usage was derived using the answer to &quot;Did you take any medications to treat this headache?&quot; in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as &quot;Yes&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC) Score at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PGIC Score at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12</measure>
    <time_frame>Baseline, Weeks 1 - 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Migraine on the Day After First Dosing</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Most Bothersome Symptom (MBS) Score at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the HIT-6 Score at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24</measure>
    <time_frame>Baseline, Week 24</time_frame>
    <description>The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score</measure>
    <time_frame>Baseline to Week 24</time_frame>
    <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of participants who visited to a family doctor/general practitioner has been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCRU: Visits to a Specialist</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of participants who visited to a specialist has been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCRU: Number of Emergency Department Visits Due to Your Migraine</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of participants who visited to emergency department due to your migraine has been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCRU: Number of Hospital Admissions Due to Migraine</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of participants who admitted in the hospital due to migraine has been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCRU: Total Number of Overnight Hospital Stays Due to Migraine</measure>
    <time_frame>Week 12</time_frame>
    <description>Number of participants who had total number of overnight hospital stays due to migraine has been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72</measure>
    <time_frame>Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72</measure>
    <time_frame>Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72</measure>
    <time_frame>Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72</measure>
    <time_frame>Baseline, Weeks 36, 48, 60, and 72</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">892</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eptinezumab 100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Eptinezumab 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eptinezumab</intervention_name>
    <description>Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)</description>
    <arm_group_label>Eptinezumab 100 mg</arm_group_label>
    <arm_group_label>Eptinezumab 300 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>concentrate for solution for infusion, intravenously</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The participant has a diagnosis of migraine, with a history of chronic or episodic&#xD;
             migraines of at least 12 months prior to the Screening Visit&#xD;
&#xD;
          -  The participant has a migraine onset of ≤50 years of age.&#xD;
&#xD;
          -  The participant has ≥4 migraine days per month for each month within the past 3 months&#xD;
             prior to the Screening Visit.&#xD;
&#xD;
          -  The participant has demonstrated compliance with the Headache eDiary by entry of data&#xD;
             for at least 24 of the 28 days following the Screening Visit.&#xD;
&#xD;
          -  The participant fulfils the following criteria for chronic migraine (CM) or episodic&#xD;
             migraine (EM) in prospectively collected information in the eDiary during the&#xD;
             screening period:&#xD;
&#xD;
          -  For participants with CM: Migraine occurring on ≥8 days and headache occurring on &gt;14&#xD;
             days&#xD;
&#xD;
          -  For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14&#xD;
             days&#xD;
&#xD;
          -  The participant has documented evidence of treatment failure (must be supported by&#xD;
             medical record or by physician's confirmation specific to each treatment) in the past&#xD;
             10 years of 2-4 different migraine preventive medications.&#xD;
&#xD;
          -  The participant has a history of either previous or active use of triptans for&#xD;
             migraine.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant has experienced failure on a previous treatment targeting the&#xD;
             calcitonin gene-related peptide (CGRP) pathway.&#xD;
&#xD;
          -  The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B&#xD;
             and the treatment is not the latest preventive medication prior to study inclusion.&#xD;
             The medication is regarded as the latest if the medication start date is after the&#xD;
             start date of the other preventive medications and the medication stop date is after&#xD;
             the stop date of the other preventive medications.&#xD;
&#xD;
          -  The participant has confounding and clinically significant pain syndromes, (for&#xD;
             example, fibromyalgia, chronic low back pain, complex regional pain syndrome).&#xD;
&#xD;
          -  The participant has a diagnosis of acute or active temporomandibular disorder.&#xD;
&#xD;
          -  The participant has a history or diagnosis of chronic tension-type headache, hypnic&#xD;
             headache, cluster headache, hemicrania continua, new daily persistent headache, or&#xD;
             unusual migraine subtypes such as hemiplegic migraine (sporadic and familial),&#xD;
             ophthalmoplegic migraine, and migraine with neurological accompaniments that are not&#xD;
             typical of migraine aura (diplopia, altered consciousness, or long duration).&#xD;
&#xD;
          -  The participant has a psychiatric condition that is uncontrolled and/or untreated for&#xD;
             a minimum of 6 months prior to the Screening Visit. Participants with a lifetime&#xD;
             history of psychosis and/or mania in the last 5 years prior to the Screening Visit are&#xD;
             excluded.&#xD;
&#xD;
          -  The participant has a history of clinically significant cardiovascular disease or&#xD;
             vascular ischaemia or thromboembolic events (for example, cerebrovascular accident,&#xD;
             deep vein thrombosis, or pulmonary embolism).&#xD;
&#xD;
        Other in- and exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Email contact via H. Lundbeck A/S</last_name>
    <role>Study Director</role>
    <affiliation>LundbeckClinicalTrials@Lundbeck.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diablo Clinical Research</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarkis Clinical Trials - Gainesville</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - Maitland</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Headache and Neurological Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104-5131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute Inc. - Minneapolis</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuqerque Clinical Trials</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dent Neurologic Institute - Amherst</name>
      <address>
        <city>Amherst</city>
        <state>New York</state>
        <zip>14226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrative Clinical Trials</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTI Clinical Research Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hometown Urgent Care &amp; Occupational Health/Hometown Research - Huber Heights</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute - Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Neuroscience Solutions - Memphis</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center (NWCRC)</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Neurological</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussels</city>
        <state>Bruxelles-Capitale</state>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis - Campus Virga Jesse</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan</name>
      <address>
        <city>Brugge</city>
        <state>West-Vlaanderen</state>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum</name>
      <address>
        <city>Sofia</city>
        <state>Sofia City</state>
        <zip>1113</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Multiprofile Hospital for Active Treatment - Sofia</name>
      <address>
        <city>Sofia</city>
        <state>Sofia City</state>
        <zip>1142</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Heart and Brain EAD</name>
      <address>
        <city>Pleven</city>
        <zip>5804</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center - Teodora EOOD</name>
      <address>
        <city>Ruse</city>
        <zip>7012</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic Tokuda Hospital</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center Medica Plus</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5006</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUDr. Helena Hojdíkova s.r.o. Neurologicka Ambulance</name>
      <address>
        <city>Hradec Kralove</city>
        <state>Hradec Kralové</state>
        <zip>500 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vestra Clinics</name>
      <address>
        <city>Rychnov nad Kneznou</city>
        <state>Hradec Kralové</state>
        <zip>516 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCR Brno</name>
      <address>
        <city>Brno</city>
        <state>Jihormoravsky Kraj</state>
        <zip>602 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava-Poruba-Poruba</city>
        <state>Moravian-Silesian</state>
        <zip>708 52</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní Thomayerova nemocnice</name>
      <address>
        <city>Praha 4</city>
        <state>Prague</state>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologicka Ambulance - Forbeli</name>
      <address>
        <city>Praha 6</city>
        <state>Prague</state>
        <zip>160 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuropsychiatrie S.R.O.</name>
      <address>
        <city>Praha 6</city>
        <state>Prague</state>
        <zip>160 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Neuropsychiatrické Péce</name>
      <address>
        <city>Praha 8</city>
        <state>Prague</state>
        <zip>186 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCR Prague</name>
      <address>
        <city>Praha 3</city>
        <state>Praha</state>
        <zip>130 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCR Ostrava</name>
      <address>
        <city>Ostrava</city>
        <state>Severomoravsky Kraj</state>
        <zip>702 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní Nemocnice u sv. Anny v Brne</name>
      <address>
        <city>Brno</city>
        <state>South Moravian</state>
        <zip>656 91</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Jihlava</name>
      <address>
        <city>Jihlava</city>
        <zip>586 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurosanatio s.r.o</name>
      <address>
        <city>Litomyshl</city>
        <zip>57001</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologie, MP-neuro s.r.o., poliklinika Modry pavilon</name>
      <address>
        <city>Slezska Ostrava</city>
        <zip>710 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroMed Zlín s.r.o.</name>
      <address>
        <city>Zlín</city>
        <zip>760 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet Glostrup</name>
      <address>
        <city>Glostrup</city>
        <state>Hovedstaden</state>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital</name>
      <address>
        <city>Odense</city>
        <state>Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydvestjysk Sygehus - Esbjerg</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampereen Yliopistollinen Sairaala</name>
      <address>
        <city>Tampere</city>
        <state>Länsi-Suomen Lääni</state>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terveystalo Ruoholahti</name>
      <address>
        <city>Helsinki</city>
        <state>Southern Finland</state>
        <zip>00180</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terveystalo Turku Pulssi</name>
      <address>
        <city>Turku</city>
        <state>Western Finland</state>
        <zip>20100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Itä-Suomen Yliopisto - Kuopion Kampus</name>
      <address>
        <city>Kuopio</city>
        <zip>70210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terveystalo Tampere</name>
      <address>
        <city>Tampere</city>
        <zip>33100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cimiez</name>
      <address>
        <city>Nice Cedex 1</city>
        <state>Côte-d'Or</state>
        <zip>91179 - 06003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Charles-Nicolle</name>
      <address>
        <city>Rouen</city>
        <state>Haute-Normandie</state>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Roger Salengro</name>
      <address>
        <city>Lille Cedex</city>
        <state>Nord</state>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hosptitalier Universitaire d'Angers</name>
      <address>
        <city>Angers</city>
        <state>Pays De La Loire</state>
        <zip>49 933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille cedex 5</city>
        <state>Provence Alpes Cote D'Azure</state>
        <zip>13 354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pierre Wertheimer</name>
      <address>
        <city>Bron</city>
        <state>Rhone-Alps</state>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsicore - Israeli-Georgian Medical Research Clinic</name>
      <address>
        <city>T'bilisi</city>
        <state>Tbilisi</state>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC Todua Clinic</name>
      <address>
        <city>T'bilisi</city>
        <state>Tbilisi</state>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pineo Medical Ecosystem</name>
      <address>
        <city>Tbilisi</city>
        <zip>0114</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Archangel Saint Michael Multiprofile Clinical Hospital</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aversi Clinic - Central Branch</name>
      <address>
        <city>Tbilisi</city>
        <zip>0160</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mediclub Georgia Medical</name>
      <address>
        <city>Tbilisi</city>
        <zip>0160</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jerarsi Clinic</name>
      <address>
        <city>Tbilisi</city>
        <zip>0167</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malkhaz Katsiashvili Multiprofile Emergency Center</name>
      <address>
        <city>Tbilisi</city>
        <zip>0172</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Simon Khechinashvili University Hospital</name>
      <address>
        <city>Tbilisi</city>
        <zip>0179</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consilium Medulla Multiprofile Clinic</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MVZ Dr. Roth &amp; Kollegen GbR</name>
      <address>
        <city>Ostfildern</city>
        <state>Baden-Wuerttemberg</state>
        <zip>73760</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuroplus</name>
      <address>
        <city>Mannheim</city>
        <state>Baden-Württemberg</state>
        <zip>68163</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroConcept AG</name>
      <address>
        <city>Stuttgart</city>
        <state>Baden-Württemberg</state>
        <zip>70182</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Steinwachs</name>
      <address>
        <city>Nürnberg</city>
        <state>Bayern</state>
        <zip>90402</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTC North</name>
      <address>
        <city>Hamburg</city>
        <state>Hamburg (Hansestadt)</state>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Migräne- und Kopfschmerzklinik Königstein</name>
      <address>
        <city>Königstein Im Taunus</city>
        <state>Hessen</state>
        <zip>61462</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Prüfzentrum Frankfurt/Main</name>
      <address>
        <city>Frankfurt am Main</city>
        <state>Hesse</state>
        <zip>60313</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Nord West</name>
      <address>
        <city>Westerstede</city>
        <state>Niedersachsen</state>
        <zip>26655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurozentrum Bielefeld</name>
      <address>
        <city>Bielefeld</city>
        <state>Nordrhein-Westfalen</state>
        <zip>33647</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Praxis Dr. Stude</name>
      <address>
        <city>Bochum</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Astrid Gendolla</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Leipzig</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research - Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12627</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuropraxis München Süd</name>
      <address>
        <city>Unterhaching</city>
        <zip>82008</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valeomed Diagnosztikai Kozpont</name>
      <address>
        <city>Esztergom</city>
        <state>Komarom-Esztergom County</state>
        <zip>2500</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pest Megyei Flor Ferenc Korhaz</name>
      <address>
        <city>Kistarcsa</city>
        <state>Pest</state>
        <zip>2143</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNO Medical Trials Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1152</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana</name>
      <address>
        <city>Rome</city>
        <state>Roma</state>
        <zip>00163</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Campus Bio-Medico di Roma</name>
      <address>
        <city>Roma</city>
        <state>Rome</state>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera - Universitaria Sant' Andrea</name>
      <address>
        <city>Roma</city>
        <state>Rome</state>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Delle Scienze Neurologiche di Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero - Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Mondino - Istituto Neurologico Nazionale a Carattere Scientifico IRCCS</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Oporow</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>52-416</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia - Bydgoszcz</name>
      <address>
        <city>Bydgoszcz</city>
        <state>Kujawsko-pomorskie</state>
        <zip>85-796</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-093</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indywidualna Praktyka Lekarska dr hab. n. med. Anna Szczepanska-Szerej</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-582</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pratia MCM Krakow</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specjalistyczne Gabinety Sp. z o.o.</name>
      <address>
        <city>Krakow</city>
        <state>Malopolskie</state>
        <zip>30-539</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Zdrowia dr Boczarska-Jedynak</name>
      <address>
        <city>Oswiecim</city>
        <state>Malopolskie</state>
        <zip>32-600</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concept Medica Trials Prywatny Gabinet Lekarski Urszula Chyrchel-Paszkiewicz</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>00-773</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOMED CR - Warsaw</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>01-737</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MTZ Clinical Research Powered by Pratia</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>01-868</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Gdynia</name>
      <address>
        <city>Gdynia</city>
        <state>Pomorskie</state>
        <zip>81-537</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Care Katowice</name>
      <address>
        <city>Siemianowice Slaskie</city>
        <state>Silesia</state>
        <zip>41-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Czestochowa</name>
      <address>
        <city>Czestochowa</city>
        <state>Slaskie</state>
        <zip>42-202</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Katowice</name>
      <address>
        <city>Katowice</city>
        <state>Slaskie</state>
        <zip>40-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska</name>
      <address>
        <city>Elblag</city>
        <state>Warminsko-Mazurskie</state>
        <zip>82-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Solumed</name>
      <address>
        <city>Poznan</city>
        <state>Wielkopolskie</state>
        <zip>60-529</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Poznan</name>
      <address>
        <city>Poznan</city>
        <state>Wielkopolskie</state>
        <zip>60-702</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia - Czestochowa</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOMED CR - Lodz</name>
      <address>
        <city>Lodz</city>
        <zip>90-368</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Headache Clinic</name>
      <address>
        <city>Moscow</city>
        <zip>121467</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologicka ambulancia MUDr. Dupejova s.r.o.</name>
      <address>
        <city>Banska Bystrica</city>
        <zip>97404</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>In Medic</name>
      <address>
        <city>Bardejov</city>
        <zip>8501</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MEDBAJ s.r.o.</name>
      <address>
        <city>Dolny Kubin</city>
        <zip>026 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicínske Centrum Konzílium - Dubnica nad Vahom</name>
      <address>
        <city>Dubnica nad Vahom</city>
        <zip>01841</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Basurto</name>
      <address>
        <city>Bilbao</city>
        <state>Biscay</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro - Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quironsalud Madrid</name>
      <address>
        <city>Pozuelo de Alarcon</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra - Pamplona</name>
      <address>
        <city>Pamplona</city>
        <state>Navarre</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alvaro Cunqueiro - Clinico Universitario Vigo</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36213</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>València</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Lozano Blesa</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Migränkliniken Europa AB</name>
      <address>
        <city>Värnamo</city>
        <state>Kronoborgs Län</state>
        <zip>331 50</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stortorgets neurologmottagning</name>
      <address>
        <city>Helsingborg</city>
        <state>Skåne Län</state>
        <zip>25220</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralsjukhuset Kristianstad</name>
      <address>
        <city>Kristianstad</city>
        <state>Skåne Län</state>
        <zip>291 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitetssjukhuset i Linköping</name>
      <address>
        <city>Linkoeping</city>
        <state>Östergötlands Län</state>
        <zip>581 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Scotland Clinical Research Centre</name>
      <address>
        <city>Bellshill</city>
        <state>England</state>
        <zip>ML4 3NJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - The Lancashire Clinic</name>
      <address>
        <city>Chorley</city>
        <state>England</state>
        <zip>PR7 7NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Midlands Clinical Research Centre</name>
      <address>
        <city>Edgbaston</city>
        <state>England</state>
        <zip>B15 2SQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - The Hexham Clinic</name>
      <address>
        <city>Hexham</city>
        <state>England</state>
        <zip>NE46 1QJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Merseyside Clinical Research Centre</name>
      <address>
        <city>Liverpool</city>
        <state>England</state>
        <zip>L22 0LG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panthera Biopartners - North London</name>
      <address>
        <city>London</city>
        <state>England</state>
        <zip>EN3 4GS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Manchester Clinical Research Centre</name>
      <address>
        <city>Manchester</city>
        <state>England</state>
        <zip>M15 6SE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panthera Biopartners - Manchester</name>
      <address>
        <city>Manchester</city>
        <state>England</state>
        <zip>OL11 4AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Panthera Biopartners - Preston</name>
      <address>
        <city>Preston</city>
        <state>England</state>
        <zip>PR2 9QB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Thames Valley Clinical Research Centre</name>
      <address>
        <city>Reading</city>
        <state>England</state>
        <zip>RG2 0TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Care Alliance NHS Foundation Trust</name>
      <address>
        <city>Salford</city>
        <state>England</state>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus - Wales</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF15 9SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <results_first_submitted>June 16, 2022</results_first_submitted>
  <results_first_submitted_qc>July 20, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 22, 2022</results_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04418765/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 13, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04418765/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study included 2 periods: Placebo-controlled Period - 24-week double-blind treatment period with placebo or eptinezumab and Extension Period - 48-week dose-blinded period with eptinezumab after completion of the Placebo-controlled Period.</recruitment_details>
      <pre_assignment_details>The Extension Period of this study is ongoing. The results of Extension Period will be reported at the time of final results posting after study completion.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo matched to eptinezumab by intravenous (IV) infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
        <group group_id="P2">
          <title>Eptinezumab 100 mg</title>
          <description>Participants received eptinezumab 100 milligrams (mg) by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
        <group group_id="P3">
          <title>Eptinezumab 300 mg</title>
          <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="299"/>
                <participants group_id="P2" count="299"/>
                <participants group_id="P3" count="294"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="298"/>
                <participants group_id="P2" count="299"/>
                <participants group_id="P3" count="294"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="293"/>
                <participants group_id="P2" count="288"/>
                <participants group_id="P3" count="284"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of monthly migraine days (MMDs) in Weeks 1 to 12.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
        <group group_id="B2">
          <title>Eptinezumab 100 mg</title>
          <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
        <group group_id="B3">
          <title>Eptinezumab 300 mg</title>
          <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="298"/>
            <count group_id="B2" value="299"/>
            <count group_id="B3" value="293"/>
            <count group_id="B4" value="890"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43.8" spread="10.83"/>
                    <measurement group_id="B2" value="44.6" spread="10.76"/>
                    <measurement group_id="B3" value="43.1" spread="10.2"/>
                    <measurement group_id="B4" value="43.8" spread="10.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="263"/>
                    <measurement group_id="B2" value="277"/>
                    <measurement group_id="B3" value="260"/>
                    <measurement group_id="B4" value="800"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="285"/>
                    <measurement group_id="B2" value="288"/>
                    <measurement group_id="B3" value="281"/>
                    <measurement group_id="B4" value="854"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not collected</title>
                  <measurement_list>
                    <measurement group_id="B1" value="296"/>
                    <measurement group_id="B2" value="298"/>
                    <measurement group_id="B3" value="290"/>
                    <measurement group_id="B4" value="884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly Migraine Days (MMDs)</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D as defined in the outcome measure 1.</description>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.9" spread="5.72"/>
                    <measurement group_id="B2" value="13.8" spread="5.58"/>
                    <measurement group_id="B3" value="13.7" spread="5.44"/>
                    <measurement group_id="B4" value="13.8" spread="5.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly Headache Days (MHDs)</title>
          <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D in outcome measure 1).</description>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.5" spread="5.79"/>
                    <measurement group_id="B2" value="14.5" spread="5.63"/>
                    <measurement group_id="B3" value="14.4" spread="5.45"/>
                    <measurement group_id="B4" value="14.5" spread="5.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Headache Impact Test (HIT-6) Score</title>
          <description>HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
          <population>Here, number analyzed = participants evaluable for this baseline measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="288"/>
                    <count group_id="B2" value="281"/>
                    <count group_id="B3" value="287"/>
                    <count group_id="B4" value="856"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.2" spread="4.38"/>
                    <measurement group_id="B2" value="66.6" spread="4.7"/>
                    <measurement group_id="B3" value="66.5" spread="4.41"/>
                    <measurement group_id="B4" value="66.4" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage of Migraine Attacks With Severe Pain Intensity</title>
          <description>A migraine attack was defined as a headache that occurred on a single day or lasted &gt;1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D in outcome measure 1).</description>
          <units>percentage of migraine attacks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.4" spread="29.74"/>
                    <measurement group_id="B2" value="47.1" spread="29.82"/>
                    <measurement group_id="B3" value="43.9" spread="28.4"/>
                    <measurement group_id="B4" value="43.8" spread="29.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage of Headache Episodes With Severe Pain Intensity</title>
          <description>A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D in outcome measure 1).</description>
          <units>percentage of headache episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.5" spread="29.29"/>
                    <measurement group_id="B2" value="44.2" spread="28.56"/>
                    <measurement group_id="B3" value="41" spread="27.01"/>
                    <measurement group_id="B4" value="41.2" spread="28.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Acute Migraine Medication Days</title>
          <population>Here, number analyzed = participants evaluable for this baseline measure.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="292"/>
                    <count group_id="B4" value="889"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.2" spread="5.93"/>
                    <measurement group_id="B2" value="11.2" spread="5.47"/>
                    <measurement group_id="B3" value="11" spread="5.29"/>
                    <measurement group_id="B4" value="11.1" spread="5.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>MMDs With Use of Acute Medication</title>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="298"/>
                    <count group_id="B2" value="299"/>
                    <count group_id="B3" value="293"/>
                    <count group_id="B4" value="890"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.5" spread="5.62"/>
                    <measurement group_id="B2" value="12.7" spread="5.48"/>
                    <measurement group_id="B3" value="12.4" spread="5.38"/>
                    <measurement group_id="B4" value="12.5" spread="5.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Migraine-Specific Quality of Life (MSQ) Subscores</title>
          <description>The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.</description>
          <population>Here, number analyzed = participants evaluable for this baseline measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>MSQ role function-restrictive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="288"/>
                    <count group_id="B2" value="276"/>
                    <count group_id="B3" value="287"/>
                    <count group_id="B4" value="851"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.1" spread="17.14"/>
                    <measurement group_id="B2" value="35.7" spread="17.33"/>
                    <measurement group_id="B3" value="35.7" spread="16.68"/>
                    <measurement group_id="B4" value="35.5" spread="17.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQ role function-preventive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="288"/>
                    <count group_id="B2" value="276"/>
                    <count group_id="B3" value="287"/>
                    <count group_id="B4" value="851"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.5" spread="22.14"/>
                    <measurement group_id="B2" value="50.2" spread="21.39"/>
                    <measurement group_id="B3" value="51" spread="21.47"/>
                    <measurement group_id="B4" value="50.6" spread="21.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQ emotional function</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="288"/>
                    <count group_id="B2" value="276"/>
                    <count group_id="B3" value="287"/>
                    <count group_id="B4" value="851"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.4" spread="26.63"/>
                    <measurement group_id="B2" value="50.3" spread="24.7"/>
                    <measurement group_id="B3" value="48.6" spread="23.8"/>
                    <measurement group_id="B4" value="49.1" spread="25.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score</title>
          <description>The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).</description>
          <population>Here, number analyzed = participants evaluable for this baseline measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="287"/>
                    <count group_id="B2" value="276"/>
                    <count group_id="B3" value="285"/>
                    <count group_id="B4" value="848"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74" spread="20.36"/>
                    <measurement group_id="B2" value="75.9" spread="19.01"/>
                    <measurement group_id="B3" value="74.5" spread="20.72"/>
                    <measurement group_id="B4" value="74.8" spread="20.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment</title>
          <description>WPAI Questionnaire contains 6 items that measure: 1) employment status, 2) hours missed from work due to specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity.</description>
          <population>Here, number analyzed = participants evaluable for this baseline measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>WPAI Absenteeism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="218"/>
                    <count group_id="B2" value="196"/>
                    <count group_id="B3" value="209"/>
                    <count group_id="B4" value="623"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.8" spread="20.7"/>
                    <measurement group_id="B2" value="11.4" spread="19.4"/>
                    <measurement group_id="B3" value="12" spread="19.31"/>
                    <measurement group_id="B4" value="12.1" spread="19.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WPAI Presenteeism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="212"/>
                    <count group_id="B2" value="191"/>
                    <count group_id="B3" value="206"/>
                    <count group_id="B4" value="609"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.7" spread="24.22"/>
                    <measurement group_id="B2" value="50.8" spread="25.61"/>
                    <measurement group_id="B3" value="53.3" spread="24.01"/>
                    <measurement group_id="B4" value="52" spread="24.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WPAI Work productivity loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="212"/>
                    <count group_id="B2" value="191"/>
                    <count group_id="B3" value="206"/>
                    <count group_id="B4" value="609"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.6" spread="24.7"/>
                    <measurement group_id="B2" value="53.7" spread="26.17"/>
                    <measurement group_id="B3" value="57" spread="24.1"/>
                    <measurement group_id="B4" value="55.5" spread="24.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WPAI Activity impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="286"/>
                    <count group_id="B2" value="274"/>
                    <count group_id="B3" value="285"/>
                    <count group_id="B4" value="845"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.7" spread="23.52"/>
                    <measurement group_id="B2" value="58.5" spread="23.47"/>
                    <measurement group_id="B3" value="59.1" spread="23.37"/>
                    <measurement group_id="B4" value="58.7" spread="23.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12</title>
        <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
        <time_frame>Baseline, Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="0.38"/>
                    <measurement group_id="O2" value="-4.8" spread="0.37"/>
                    <measurement group_id="O3" value="-5.3" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using a restricted maximum likelihood (REML)-based mixed model for repeated measurements (MMRM) with month (Weeks 1-4, 5-8, 9-12, 13-16, 17-20, 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/&gt;14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction. A testing strategy was applied to ensure protection of the type 1 error.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value &lt;α, where α = 0.05. Here it is test no. 1 of testing order.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>-2.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/&gt;14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value &lt;α, where α = 0.05. Here it is test no. 3 of testing order.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.4</ci_lower_limit>
            <ci_upper_limit>-2.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</title>
        <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
        <time_frame>Baseline to Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1"/>
                    <measurement group_id="O2" value="42.1"/>
                    <measurement group_id="O3" value="49.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/&gt;14) as factors.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value &lt;α, where α = 0.05. Here it is test no. 2 of testing order.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>6.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.41</ci_lower_limit>
            <ci_upper_limit>10.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/&gt;14) as factors.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Testing continued only, if the previous comparison was statistically significant. Threshold for significance: p-value &lt;α, where α = 0.05. Here it is test no. 4 of testing order.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.29</ci_lower_limit>
            <ci_upper_limit>7.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24</title>
        <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
        <time_frame>Baseline, Weeks 13 - 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="295"/>
                <count group_id="O2" value="287"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="0.39"/>
                    <measurement group_id="O2" value="-5.4" spread="0.39"/>
                    <measurement group_id="O3" value="-6.1" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/&gt;14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance: p-value &lt;α, where α = 0.05. Here it is test no. 5a of testing order.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Testing continued only, if the previous comparison was statistically significant.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>-3.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using an REML-based MMRM with month (Weeks 1-4, Weeks 5-8, Weeks 9-12, Weeks 13-16, Weeks 17-20, Weeks 21-24), country, stratification factor (monthly MHDs at baseline: ≤14/&gt;14) and treatment as factors, baseline score as a continuous covariate, treatment-by-month interaction, baseline score-by-month interaction, and stratum-by-month interaction.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be &lt;α/3, &lt;α/2, and &lt;α, where α = 0.05. Here it is test no. 6a of testing order.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Testing continued only, if the previous comparison was statistically significant.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.8</ci_lower_limit>
            <ci_upper_limit>-2.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</title>
        <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
        <time_frame>Baseline to Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0"/>
                    <measurement group_id="O2" value="15.7"/>
                    <measurement group_id="O3" value="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/&gt;14) as factors.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.&#xD;
Testing continued only, if the previous comparison was statistically significant.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be &lt;α/3, &lt;α/2, and &lt;α, where α = 0.05. Here it is test no. 5b of testing order.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>11.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.22</ci_lower_limit>
            <ci_upper_limit>30.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using logistic regression model including baseline MMDs as a continuous covariate, and treatment and stratification factor (MHD at baseline: ≤14/&gt;14) as factors.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.&#xD;
Testing continued only, if the previous comparison was statistically significant.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be &lt;α/3, &lt;α/2, and &lt;α, where α = 0.05. Here it is test no. 6b of testing order.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>9.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.16</ci_lower_limit>
            <ci_upper_limit>24.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12</title>
        <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12</title>
          <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="288"/>
                <count group_id="O2" value="277"/>
                <count group_id="O3" value="283"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="0.61"/>
                    <measurement group_id="O2" value="-6.9" spread="0.61"/>
                    <measurement group_id="O3" value="-8.5" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/&gt;14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.&#xD;
Testing continued only, if the previous comparison was statistically significant.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be &lt;α/3, &lt;α/2, and &lt;α, where α = 0.05. Here it is test no. 5c of testing order.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.63</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.7</ci_lower_limit>
            <ci_upper_limit>-4.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using MMRM with the following fixed effects: visit, country, stratification factor (MHDs at baseline: ≤14/&gt;14) and treatment as factors, baseline HIT-6 Total Score as a continuous covariate, baseline score-by-visit interaction, treatment-by-visit interaction, and stratum-by-visit interaction.&#xD;
A testing strategy (sequence of tests) was applied to ensure protection of the type 1 error.&#xD;
Testing continued only, if the previous comparison was statistically significant.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Testing sequence: 1. Change in MMDs (Weeks 1-12) 300 mg vs placebo; 2. 50% responders for MMDs (Weeks 1-12) 300 mg vs placebo; 3. Change in MMDs (Weeks 1-12) 100 mg vs placebo; 4. 50% responders for MMDs (Weeks 1-12) 100 mg vs placebo; 5a. Change in MMDs (Weeks 13-24), 5b. 75% responders for MMDs (Weeks 1-12), 5c. Change in HIT-6 (Week 12) 300 mg vs placebo; 6a. Change in MMDs (Weeks 13-24), 6b. 75% responders for MMDs (Weeks 1-12), 6c. Change in HIT-6 (Week 12) 100 mg vs placebo.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance: The consecutive order of the smallest (p1), the second smallest (p2), and the largest p-value (p3) had to be &lt;α/3, &lt;α/2, and &lt;α, where α = 0.05. Here it is test no. 6c of testing order.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.63</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.0</ci_lower_limit>
            <ci_upper_limit>-2.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24</title>
        <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
        <time_frame>Baseline to Weeks 13 - 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="295"/>
                <count group_id="O2" value="287"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7"/>
                    <measurement group_id="O2" value="52.3"/>
                    <measurement group_id="O3" value="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24</title>
        <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
        <time_frame>Baseline to Weeks 13 - 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="295"/>
                <count group_id="O2" value="287"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="21.3"/>
                    <measurement group_id="O3" value="27.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</title>
        <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
        <time_frame>Baseline to Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12</title>
          <description>A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="5.9"/>
                    <measurement group_id="O3" value="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</title>
        <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
        <time_frame>Baseline to Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</title>
          <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8"/>
                    <measurement group_id="O2" value="39.5"/>
                    <measurement group_id="O3" value="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</title>
        <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
        <time_frame>Baseline to Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</title>
          <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                    <measurement group_id="O2" value="15.1"/>
                    <measurement group_id="O3" value="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</title>
        <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
        <time_frame>Baseline to Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12</title>
          <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="4.1"/>
                    <measurement group_id="O3" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12</title>
        <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
        <time_frame>Baseline, Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12</title>
          <description>A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="0.38"/>
                    <measurement group_id="O2" value="-4.6" spread="0.37"/>
                    <measurement group_id="O3" value="-5.1" spread="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12</title>
        <description>A migraine attack was defined as a headache that occurred on a single day or lasted &gt;1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
        <time_frame>Baseline, Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12</title>
          <description>A migraine attack was defined as a headache that occurred on a single day or lasted &gt;1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of migraine attacks</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.2" spread="1.91"/>
                    <measurement group_id="O2" value="-17.9" spread="1.87"/>
                    <measurement group_id="O3" value="-21.3" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12</title>
        <description>A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
        <time_frame>Baseline, Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12</title>
          <description>A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of headache episodes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.8" spread="1.85"/>
                    <measurement group_id="O2" value="-16.2" spread="1.81"/>
                    <measurement group_id="O3" value="-19.5" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12</title>
        <description>In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.</description>
        <time_frame>Baseline, Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12</title>
          <description>In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="298"/>
                <count group_id="O3" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="0.34"/>
                    <measurement group_id="O2" value="-4.1" spread="0.33"/>
                    <measurement group_id="O3" value="-4.6" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24</title>
        <description>In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.</description>
        <time_frame>Baseline, Weeks 13- 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24</title>
          <description>In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="294"/>
                <count group_id="O2" value="287"/>
                <count group_id="O3" value="285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="0.36"/>
                    <measurement group_id="O2" value="-4.6" spread="0.36"/>
                    <measurement group_id="O3" value="-5.2" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12</title>
        <description>Number of MMDs with acute medication usage was derived using the answer to &quot;Did you take any medications to treat this headache?&quot; in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as &quot;Yes&quot;.</description>
        <time_frame>Baseline, Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12</title>
          <description>Number of MMDs with acute medication usage was derived using the answer to &quot;Did you take any medications to treat this headache?&quot; in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as &quot;Yes&quot;.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="0.36"/>
                    <measurement group_id="O2" value="-4.6" spread="0.36"/>
                    <measurement group_id="O3" value="-5.2" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24</title>
        <description>Number of MMDs with acute medication usage was derived using the answer to &quot;Did you take any medications to treat this headache?&quot; in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as &quot;Yes&quot;.</description>
        <time_frame>Baseline, Weeks 13 - 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24</title>
          <description>Number of MMDs with acute medication usage was derived using the answer to &quot;Did you take any medications to treat this headache?&quot; in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as &quot;Yes&quot;.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="295"/>
                <count group_id="O2" value="287"/>
                <count group_id="O3" value="286"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="0.39"/>
                    <measurement group_id="O2" value="-4.9" spread="0.39"/>
                    <measurement group_id="O3" value="-5.8" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGIC) Score at Week 12</title>
        <description>The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGIC) Score at Week 12</title>
          <description>The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="292"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="0.09"/>
                    <measurement group_id="O2" value="2.6" spread="0.09"/>
                    <measurement group_id="O3" value="2.5" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PGIC Score at Week 24</title>
        <description>The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.</description>
        <time_frame>Week 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>PGIC Score at Week 24</title>
          <description>The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="286"/>
                <count group_id="O2" value="280"/>
                <count group_id="O3" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="0.09"/>
                    <measurement group_id="O2" value="2.5" spread="0.09"/>
                    <measurement group_id="O3" value="2.4" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12</title>
        <time_frame>Baseline, Weeks 1 - 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12</title>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>days/month</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="1.12"/>
                    <measurement group_id="O2" value="-5.6" spread="1.07"/>
                    <measurement group_id="O3" value="-7.3" spread="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Migraine on the Day After First Dosing</title>
        <time_frame>Day 1</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Migraine on the Day After First Dosing</title>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="298"/>
                <count group_id="O2" value="299"/>
                <count group_id="O3" value="293"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.7"/>
                    <measurement group_id="O2" value="27.2"/>
                    <measurement group_id="O3" value="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Most Bothersome Symptom (MBS) Score at Week 12</title>
        <description>Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Most Bothersome Symptom (MBS) Score at Week 12</title>
          <description>Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="293"/>
                <count group_id="O2" value="289"/>
                <count group_id="O3" value="287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="0.09"/>
                    <measurement group_id="O2" value="2.8" spread="0.09"/>
                    <measurement group_id="O3" value="2.7" spread="0.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the HIT-6 Score at Week 24</title>
        <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the HIT-6 Score at Week 24</title>
          <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="266"/>
                <count group_id="O3" value="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.9" spread="0.63"/>
                    <measurement group_id="O2" value="-8.9" spread="0.63"/>
                    <measurement group_id="O3" value="-9.9" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12</title>
        <description>The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12</title>
          <description>The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="288"/>
                <count group_id="O2" value="271"/>
                <count group_id="O3" value="283"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MSQ Role Function-Restrictive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" spread="1.75"/>
                    <measurement group_id="O2" value="25.0" spread="1.75"/>
                    <measurement group_id="O3" value="28.7" spread="1.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQ Role Function-Preventive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="1.63"/>
                    <measurement group_id="O2" value="22.7" spread="1.64"/>
                    <measurement group_id="O3" value="25.0" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQ Emotional Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" spread="1.83"/>
                    <measurement group_id="O2" value="20.6" spread="1.84"/>
                    <measurement group_id="O3" value="23.1" spread="1.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12</title>
        <description>The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12</title>
          <description>The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="287"/>
                <count group_id="O2" value="271"/>
                <count group_id="O3" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.1" spread="1.39"/>
                    <measurement group_id="O2" value="2.0" spread="1.40"/>
                    <measurement group_id="O3" value="4.4" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24</title>
        <description>The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24</title>
          <description>The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="278"/>
                <count group_id="O2" value="259"/>
                <count group_id="O3" value="275"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MSQ Role Function-Restrictive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="1.76"/>
                    <measurement group_id="O2" value="30.1" spread="1.78"/>
                    <measurement group_id="O3" value="30.0" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQ Role Function-Preventive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="1.63"/>
                    <measurement group_id="O2" value="25.7" spread="1.65"/>
                    <measurement group_id="O3" value="26.3" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MSQ Emotional Function</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="1.84"/>
                    <measurement group_id="O2" value="24.1" spread="1.86"/>
                    <measurement group_id="O3" value="24.1" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24</title>
        <description>The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24</title>
          <description>The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="276"/>
                <count group_id="O2" value="258"/>
                <count group_id="O3" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="1.38"/>
                    <measurement group_id="O2" value="2.0" spread="1.40"/>
                    <measurement group_id="O3" value="5.2" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12</title>
        <description>The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12</title>
          <description>The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified categories.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="286"/>
                <count group_id="O2" value="268"/>
                <count group_id="O3" value="280"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absenteeism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="196"/>
                    <count group_id="O2" value="174"/>
                    <count group_id="O3" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="1.49"/>
                    <measurement group_id="O2" value="-5.8" spread="1.53"/>
                    <measurement group_id="O3" value="-3.8" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" spread="2.42"/>
                    <measurement group_id="O2" value="-19.0" spread="2.46"/>
                    <measurement group_id="O3" value="-23.3" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work productivity loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                    <count group_id="O2" value="169"/>
                    <count group_id="O3" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.7" spread="2.56"/>
                    <measurement group_id="O2" value="-19.5" spread="2.61"/>
                    <measurement group_id="O3" value="-24.0" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="268"/>
                    <count group_id="O3" value="280"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.2" spread="2.07"/>
                    <measurement group_id="O2" value="-21.3" spread="2.07"/>
                    <measurement group_id="O3" value="-23.8" spread="2.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24</title>
        <description>The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.</description>
        <time_frame>Baseline, Week 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24</title>
          <description>The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable for specified categories.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="275"/>
                <count group_id="O2" value="256"/>
                <count group_id="O3" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absenteeism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="151"/>
                    <count group_id="O3" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="1.46"/>
                    <measurement group_id="O2" value="-5.2" spread="1.53"/>
                    <measurement group_id="O3" value="-5.4" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Presenteeism</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="145"/>
                    <count group_id="O3" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="2.49"/>
                    <measurement group_id="O2" value="-22.2" spread="2.59"/>
                    <measurement group_id="O3" value="-19.3" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work productivity loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="145"/>
                    <count group_id="O3" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.2" spread="2.62"/>
                    <measurement group_id="O2" value="-22.6" spread="2.73"/>
                    <measurement group_id="O3" value="-20.2" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activity impairment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="275"/>
                    <count group_id="O2" value="256"/>
                    <count group_id="O3" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="2.07"/>
                    <measurement group_id="O2" value="-24.7" spread="2.09"/>
                    <measurement group_id="O3" value="-22.6" spread="2.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score</title>
        <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score</title>
          <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="288"/>
                <count group_id="O2" value="280"/>
                <count group_id="O3" value="284"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9"/>
                    <measurement group_id="O2" value="62.1"/>
                    <measurement group_id="O3" value="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score</title>
        <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
        <time_frame>Baseline to Week 24</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score</title>
          <description>The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="288"/>
                <count group_id="O2" value="280"/>
                <count group_id="O3" value="285"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2"/>
                    <measurement group_id="O2" value="72.1"/>
                    <measurement group_id="O3" value="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner</title>
        <description>Number of participants who visited to a family doctor/general practitioner has been reported.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner</title>
          <description>Number of participants who visited to a family doctor/general practitioner has been reported.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="291"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="244"/>
                    <measurement group_id="O2" value="259"/>
                    <measurement group_id="O3" value="256"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>8 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HCRU: Visits to a Specialist</title>
        <description>Number of participants who visited to a specialist has been reported.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>HCRU: Visits to a Specialist</title>
          <description>Number of participants who visited to a specialist has been reported.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="291"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="249"/>
                    <measurement group_id="O2" value="256"/>
                    <measurement group_id="O3" value="257"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>8 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HCRU: Number of Emergency Department Visits Due to Your Migraine</title>
        <description>Number of participants who visited to emergency department due to your migraine has been reported.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>HCRU: Number of Emergency Department Visits Due to Your Migraine</title>
          <description>Number of participants who visited to emergency department due to your migraine has been reported.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="291"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="289"/>
                    <measurement group_id="O2" value="289"/>
                    <measurement group_id="O3" value="285"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>8 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HCRU: Number of Hospital Admissions Due to Migraine</title>
        <description>Number of participants who admitted in the hospital due to migraine has been reported.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>HCRU: Number of Hospital Admissions Due to Migraine</title>
          <description>Number of participants who admitted in the hospital due to migraine has been reported.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="291"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="295"/>
                    <measurement group_id="O2" value="289"/>
                    <measurement group_id="O3" value="287"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HCRU: Total Number of Overnight Hospital Stays Due to Migraine</title>
        <description>Number of participants who had total number of overnight hospital stays due to migraine has been reported.</description>
        <time_frame>Week 12</time_frame>
        <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O2">
            <title>Eptinezumab 100 mg</title>
            <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
          <group group_id="O3">
            <title>Eptinezumab 300 mg</title>
            <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
          </group>
        </group_list>
        <measure>
          <title>HCRU: Total Number of Overnight Hospital Stays Due to Migraine</title>
          <description>Number of participants who had total number of overnight hospital stays due to migraine has been reported.</description>
          <population>FAS included all randomized participants who had a valid baseline assessment and at least 1 valid post-baseline 4-week assessment of MMDs in Weeks 1 to 12. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="297"/>
                <count group_id="O2" value="291"/>
                <count group_id="O3" value="289"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="295"/>
                    <measurement group_id="O2" value="290"/>
                    <measurement group_id="O3" value="289"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 Visit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 Visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72</title>
        <time_frame>Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72</title>
        <time_frame>Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72</title>
        <time_frame>Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72</title>
        <time_frame>Baseline, Weeks 36, 48, 60, and 72</time_frame>
        <posting_date>09/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to Week 24</time_frame>
      <desc>All-patients-treated set (APTS) included all randomized participants who received at least 1 infusion of the study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo matched to eptinezumab by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
        <group group_id="E2">
          <title>Eptinezumab 100 mg</title>
          <description>Participants received eptinezumab 100 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
        <group group_id="E3">
          <title>Eptinezumab 300 mg</title>
          <description>Participants received eptinezumab 300 mg by IV infusion on Baseline (Day 0) and on Week 12.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="299"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Psychogenic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 24.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="298"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="299"/>
                <counts group_id="E3" subjects_affected="80" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="299"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="299"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="299"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="299"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="298"/>
                <counts group_id="E2" events="20" subjects_affected="19" subjects_at_risk="299"/>
                <counts group_id="E3" events="15" subjects_affected="15" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="299"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="299"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post vaccination syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="299"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="298"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="299"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="298"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="298"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="299"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressive symptom</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="299"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="294"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="298"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="299"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="298"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="299"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="294"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Email contact via</name_or_title>
      <organization>H. Lundbeck A/S</organization>
      <phone>+4536301311</phone>
      <email>LundbeckClinicalTrials@Lundbeck.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418765
org study id: 18898A
nct id: NCT04418765
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful
      prior preventive treatments.
The total study duration from the screening visit to the completion visit is approximately 76
      weeks and includes a screening period (28-30 days), a placebo-controlled treatment period (24
      weeks) and a treatment extension period (48 weeks).

      The participant will start treatment at the baseline visit and follow a 12-week dosing
      schedule with either eptinezumab (100 or 300 milligrams [mg]) or placebo by intraveneous (IV)
      infusion. Participants who were assigned to placebo in the placebo-controlled treatment
      period, will be randomly allocated to one of two treatment groups: eptinezumab 300 mg or
      eptinezumab 100 mg.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12
time frame: Baseline, Weeks 1 - 12
description: A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
measure: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
time frame: Baseline to Weeks 1 - 12
description: A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
measure: Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24
time frame: Baseline, Weeks 13 - 24
description: A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
measure: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
time frame: Baseline to Weeks 1 - 12
description: A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
measure: Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12
time frame: Baseline, Week 12
description: The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
measure: Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
time frame: Baseline to Weeks 13 - 24
description: A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
measure: Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24
time frame: Baseline to Weeks 13 - 24
description: A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
measure: Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12
time frame: Baseline to Weeks 1 - 12
description: A migraine day was defined as any day the participant reported a headache that met criterion A, B, C, or D: Criterion A (all of the following criteria): lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity; and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion B: lasted ≥30 minutes and the participant had an aura with the headache. Criterion C: lasted ≥30 minutes and met ≥2 of the following criteria: lasted ≥4 hours, had ≥2 of the following: unilateral location; pulsating quality; moderate or severe pain intensity; aggravation by, or causing avoidance of, routine physical activity, and was accompanied by ≥1 of the following: nausea; vomiting; photophobia and phonophobia. Criterion D: the participant took medication to treat the headache because he/she believed he/she was having a migraine.
measure: Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
time frame: Baseline to Weeks 1 - 12
description: A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
measure: Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
time frame: Baseline to Weeks 1 - 12
description: A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
measure: Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12
time frame: Baseline to Weeks 1 - 12
description: A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
measure: Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12
time frame: Baseline, Weeks 1 - 12
description: A headache day was defined as a day with a headache that lasted ≥30 minutes or met the definition of a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
measure: Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12
time frame: Baseline, Weeks 1 - 12
description: A migraine attack was defined as a headache that occurred on a single day or lasted >1 day and that met the criteria for a migraine day (as defined in criterion A, B, C, or D above in outcome measure 1).
measure: Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12
time frame: Baseline, Weeks 1 - 12
description: A headache episode was defined as a headache lasted ≥30 minutes or that met the criteria for a migraine (as defined in criterion A, B, C, or D above in outcome measure 1).
measure: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12
time frame: Baseline, Weeks 1 - 12
description: In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
measure: Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24
time frame: Baseline, Weeks 13- 24
description: In the evening eDiary, participants were asked each day to fill out whether they used any of the following medications during that day: Ergotamine, triptan, analgesic, opioid, or combination analgesic. A day where the participant answered that they took any of those in the evening eDiary was considered a day with use of acute migraine medication.
measure: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12
time frame: Baseline, Weeks 1 - 12
description: Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
measure: Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24
time frame: Baseline, Weeks 13 - 24
description: Number of MMDs with acute medication usage was derived using the answer to "Did you take any medications to treat this headache?" in the headache diary. The question was asked when a participant was ending a headache. Thus, a migraine day with acute medication usage was defined as a migraine day with the extra condition that this question was answered as "Yes".
measure: Patient Global Impression of Change (PGIC) Score at Week 12
time frame: Week 12
description: The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
measure: PGIC Score at Week 24
time frame: Week 24
description: The PGIC is a single, participant-reported item reflecting the participant's impression of change in his/her disease status since the start of the study (that is, in relation to activity limitations, symptoms, emotions, and overall quality of life). Participants rated their impression of change in disease status on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a higher score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status.
measure: Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12
time frame: Baseline, Weeks 1 - 12
measure: Percentage of Participants With Migraine on the Day After First Dosing
time frame: Day 1
measure: Most Bothersome Symptom (MBS) Score at Week 12
time frame: Week 12
description: Participants were asked about their most bothersome symptom associated with their migraines during the Baseline Visit. Participants were asked to rate the improvement in this symptom from baseline on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.
measure: Change From Baseline in the HIT-6 Score at Week 24
time frame: Baseline, Week 24
description: The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
measure: Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12
time frame: Baseline, Week 12
description: The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
measure: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12
time frame: Baseline, Week 12
description: The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
measure: Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24
time frame: Baseline, Week 24
description: The MSQ is a participant-reported outcome designed to assess the quality of life in participants with migraine. It consists of 14 items covering 3 domains: role function restrictive (7 items); role function preventive (4 items); and emotional function (3 items). Each item was scored on a 6-point scale ranging from 1 (none of the time) to 6 (all of the time). Raw domain scores were summed and transformed to a 0- to 100-point scale. Higher scores indicated better quality of life.
measure: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24
time frame: Baseline, Week 24
description: The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a VAS of the overall health state. Each descriptive item was rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranged from 0 (worst imaginable health state) to 100 (best imaginable health state).
measure: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12
time frame: Baseline, Week 12
description: The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.
measure: Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24
time frame: Baseline, Week 24
description: The WPAI Questionnaire is a participant-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores were calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores were calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes.
measure: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score
time frame: Baseline to Week 12
description: The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
measure: Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score
time frame: Baseline to Week 24
description: The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item was rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 was the sum of each response score ranging from 36 to 78. The life impact derived from the total score was described as followed: severe (≥60), substantial (56-59), some (50-55), little to none (≤49).
measure: Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner
time frame: Week 12
description: Number of participants who visited to a family doctor/general practitioner has been reported.
measure: HCRU: Visits to a Specialist
time frame: Week 12
description: Number of participants who visited to a specialist has been reported.
measure: HCRU: Number of Emergency Department Visits Due to Your Migraine
time frame: Week 12
description: Number of participants who visited to emergency department due to your migraine has been reported.
measure: HCRU: Number of Hospital Admissions Due to Migraine
time frame: Week 12
description: Number of participants who admitted in the hospital due to migraine has been reported.
measure: HCRU: Total Number of Overnight Hospital Stays Due to Migraine
time frame: Week 12
description: Number of participants who had total number of overnight hospital stays due to migraine has been reported.
measure: Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
time frame: Baseline, Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
measure: Number of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
time frame: Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
measure: Number of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72
time frame: Baseline to Weeks 25 - 36, 37 - 48, 49 - 60, and 61 - 72
measure: Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72
time frame: Baseline, Weeks 36, 48, 60, and 72
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants will receive placebo matching to eptinezumab by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
arm group label: Eptinezumab 100 mg
arm group type: Experimental
description: Participants will receive eptinezumab 100 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
arm group label: Eptinezumab 300 mg
arm group type: Experimental
description: Participants will receive eptinezumab 300 mg by IV infusion, every 12 weeks starting from Baseline (Day 0) through Week 24.
intervention type: Drug
intervention name: Eptinezumab
description: Eptinezumab, concentrate for solution for infusion 100 mg/milliliter (mL)
arm group label: Eptinezumab 100 mg
arm group label: Eptinezumab 300 mg
intervention type: Drug
intervention name: Placebo
description: concentrate for solution for infusion, intravenously
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Email contact via H. Lundbeck A/S
role: Study Director
affiliation: LundbeckClinicalTrials@Lundbeck.com
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country: Belgium
country: Bulgaria
country: Czechia
country: Denmark
country: Finland
country: France
country: Georgia
country: Germany
country: Hungary
country: Italy
country: Poland
country: Russian Federation
country: Slovakia
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: Yes
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 