<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/NCT02974153</url>
  </required_header>
  <id_info>
    <org_study_id>ALD403-CLIN-011</org_study_id>
    <nct_id>NCT02974153</nct_id>
  </id_info>
  <brief_title>Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine</brief_title>
  <acronym>PROMISE 2</acronym>
  <official_title>A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alder Biopharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alder Biopharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of&#xD;
      migraine headache in chronic migraineurs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Monthly Migraine Days</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>75% Migraine Responder Rate</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>75% Migraine Responder Rate - 4 Week</measure>
    <time_frame>Week 1-4</time_frame>
    <description>Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>50% Migraine Responder Rate</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Migraine on the Day After Dosing</measure>
    <time_frame>Day 1</time_frame>
    <description>The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment Day and Day 1 is the day after dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Monthly Acute Medication Days</measure>
    <time_frame>Week 1-12</time_frame>
    <description>An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline of Headache Impact Test (HIT-6) Score</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Migraine Prevalence From Baseline to Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>75% Headache Responder Rate</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>50% Headache Responder Rate</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>100% Migraine Responder Rate</measure>
    <time_frame>Week 1-12</time_frame>
    <description>For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>100% Headache Responder Rate</measure>
    <time_frame>Week 1-12</time_frame>
    <description>For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Monthly Migraine Days (Weeks 13-24)</measure>
    <time_frame>Week 13-24</time_frame>
    <description>Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Monthly Headache Days (Weeks 1-12)</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Migraine After Dosing</measure>
    <time_frame>32 weeks</time_frame>
    <description>The time to first migraine after dosing based upon the migraine data entered into the eDiary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication</measure>
    <time_frame>Week 1-12</time_frame>
    <description>The percentage of migraines with acute medication usage. Participants with no migraine will be included with a rate of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication</measure>
    <time_frame>Week 1-12</time_frame>
    <description>The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Frequency of Migraine Days - Week 1-12</measure>
    <time_frame>Week 1-12</time_frame>
    <description>The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in Frequency of Headache Days - Week 1-12</measure>
    <time_frame>Week 1-12</time_frame>
    <description>The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percentage of Severe Migraines</measure>
    <time_frame>Week 1-12</time_frame>
    <description>The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percentage of Severe Headache</measure>
    <time_frame>Week 1-12</time_frame>
    <description>The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Monthly Migraine Hours, Weeks 1-12</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Monthly Headache Hours, Weeks 1-12</measure>
    <time_frame>Week 1-12</time_frame>
    <description>Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Migraine-Free Intervals</measure>
    <time_frame>32 weeks</time_frame>
    <description>The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life (EQ-5D-5L) at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1121</enrollment>
  <condition>Migraine Disorders</condition>
  <arm_group>
    <arm_group_label>ALD403 (Eptinezumab) Dose Level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALD403 (Eptinezumab) Dose Level 1 (IV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALD403 (Eptinezumab) Dose Level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALD403 (Eptinezumab) Dose Level 2 (IV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (IV)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALD403 (Eptinezumab)</intervention_name>
    <arm_group_label>ALD403 (Eptinezumab) Dose Level 1</arm_group_label>
    <arm_group_label>ALD403 (Eptinezumab) Dose Level 2</arm_group_label>
    <other_name>Eptinezumab-jjmr</other_name>
    <other_name>Vyepti</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females between 18 and 65 years of age, inclusive, who were diagnosed with&#xD;
             migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months&#xD;
             before screening.&#xD;
&#xD;
          -  During the 28 day screening period, subjects must adequately complete the headache&#xD;
             eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must&#xD;
             be migraine days.&#xD;
&#xD;
          -  Headache eDiary was completed on at least 24 of the 28 days prior to randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low&#xD;
             back pain, complex regional pain syndrome).&#xD;
&#xD;
          -  Psychiatric conditions that are uncontrolled and/or untreated, including conditions&#xD;
             that are not controlled for a minimum of 6 months prior to screening. Patients with a&#xD;
             lifetime history of psychosis, mania, or dementia are excluded.&#xD;
&#xD;
          -  Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons&#xD;
             requiring injections within 4 months prior to screening and during the screening&#xD;
             period.&#xD;
&#xD;
          -  History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic&#xD;
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new&#xD;
             daily persistent headache, or sporadic and familial hemiplegic migraine.&#xD;
&#xD;
          -  Receipt of any monoclonal antibody treatment (within or outside a clinical trial)&#xD;
             within 6 months before screening.&#xD;
&#xD;
          -  Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Carlsbad</city>
        <state>California</state>
        <zip>92011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Redlands</city>
        <state>California</state>
        <zip>92374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Champaign</city>
        <state>Illinois</state>
        <zip>61820</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anderson</city>
        <state>Indiana</state>
        <zip>46011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Prairie Village</city>
        <state>Kansas</state>
        <zip>66208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Waldorf</city>
        <state>Maryland</state>
        <zip>20603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>North Attleboro</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Watertown</city>
        <state>Massachusetts</state>
        <zip>02472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
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        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>L'viv</city>
        <zip>79010</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Odessa</city>
        <zip>65014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69065</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Inverness</city>
        <zip>IV2 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>SE5 9PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newcastle</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salford</city>
        <zip>M8 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stoke-on-Trent</city>
        <zip>ST4 7LN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <results_first_submitted>March 19, 2020</results_first_submitted>
  <results_first_submitted_qc>May 27, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2020</results_first_posted>
  <disposition_first_submitted>September 17, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>September 17, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 19, 2018</disposition_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</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>
  <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>August 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT02974153/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>November 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT02974153/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 2263 participants signed the ICF, of which 1121 participants met the entry criteria and were randomized into the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>300 mg ALD403</title>
          <description>Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
        </group>
        <group group_id="P2">
          <title>100 mg ALD403</title>
          <description>Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
        </group>
        <group group_id="P3">
          <title>Placebo</title>
          <description>Participants were randomized to receive a single placebo IV infusion on Days 0 and 84 (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="374"/>
                <participants group_id="P2" count="372"/>
                <participants group_id="P3" count="375"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Treated</title>
              <participants_list>
                <participants group_id="P1" count="350"/>
                <participants group_id="P2" count="356"/>
                <participants group_id="P3" count="366"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="322"/>
                <participants group_id="P2" count="324"/>
                <participants group_id="P3" count="325"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="48"/>
                <participants group_id="P3" count="50"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <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="9"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Burden</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population includes all participants who received study drug or placebo.</population>
      <group_list>
        <group group_id="B1">
          <title>300 mg ALD403</title>
          <description>Participants were randomized to receive a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
        </group>
        <group group_id="B2">
          <title>100 mg ALD403</title>
          <description>Participants were randomized to receive a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
        </group>
        <group group_id="B3">
          <title>Placebo</title>
          <description>Participants were randomized to receive a single placebo IV infusion on Days 0 and 84 (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="350"/>
            <count group_id="B2" value="356"/>
            <count group_id="B3" value="366"/>
            <count group_id="B4" value="1072"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.0" spread="10.36"/>
                    <measurement group_id="B2" value="41.0" spread="11.72"/>
                    <measurement group_id="B3" value="39.6" spread="11.28"/>
                    <measurement group_id="B4" value="40.5" spread="11.15"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="314"/>
                    <measurement group_id="B2" value="307"/>
                    <measurement group_id="B3" value="325"/>
                    <measurement group_id="B4" value="946"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="332"/>
                    <measurement group_id="B2" value="323"/>
                    <measurement group_id="B3" value="331"/>
                    <measurement group_id="B4" value="986"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="00"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="322"/>
                    <measurement group_id="B2" value="332"/>
                    <measurement group_id="B3" value="321"/>
                    <measurement group_id="B4" value="975"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="195"/>
                    <measurement group_id="B2" value="198"/>
                    <measurement group_id="B3" value="232"/>
                    <measurement group_id="B4" value="625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <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_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Georgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Migraine Days</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less than 17 days per month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="206"/>
                    <measurement group_id="B4" value="602"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Greater than or equal to 17 days per month</title>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="160"/>
                    <measurement group_id="B4" value="470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication overuse headache diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="217"/>
                    <measurement group_id="B3" value="221"/>
                    <measurement group_id="B4" value="641"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="139"/>
                    <measurement group_id="B3" value="145"/>
                    <measurement group_id="B4" value="431"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Monthly Migraine Days</title>
        <description>Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Monthly Migraine Days</title>
          <description>Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>Migraine Days</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.2" lower_limit="-23" upper_limit="11"/>
                    <measurement group_id="O2" value="-7.7" lower_limit="-22" upper_limit="10"/>
                    <measurement group_id="O3" value="-5.6" lower_limit="-25" upper_limit="9"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.60</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>6.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.45</ci_lower_limit>
            <ci_upper_limit>-1.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.03</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>6.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.88</ci_lower_limit>
            <ci_upper_limit>-1.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>75% Migraine Responder Rate</title>
        <description>Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>75% Migraine Responder Rate</title>
          <description>Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</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="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116"/>
                    <measurement group_id="O2" value="95"/>
                    <measurement group_id="O3" value="55"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>18.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.0</ci_lower_limit>
            <ci_upper_limit>24.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>11.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.8</ci_lower_limit>
            <ci_upper_limit>17.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>75% Migraine Responder Rate - 4 Week</title>
        <description>Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.</description>
        <time_frame>Week 1-4</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>75% Migraine Responder Rate - 4 Week</title>
          <description>Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</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="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129"/>
                    <measurement group_id="O2" value="110"/>
                    <measurement group_id="O3" value="57"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>21.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>15.0</ci_lower_limit>
            <ci_upper_limit>27.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>15.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.3</ci_lower_limit>
            <ci_upper_limit>21.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>50% Migraine Responder Rate</title>
        <description>Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>50% Migraine Responder Rate</title>
          <description>Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</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="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="215"/>
                    <measurement group_id="O2" value="205"/>
                    <measurement group_id="O3" value="144"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>22.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.9</ci_lower_limit>
            <ci_upper_limit>29.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>18.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.1</ci_lower_limit>
            <ci_upper_limit>25.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Migraine on the Day After Dosing</title>
        <description>The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment Day and Day 1 is the day after dosing.</description>
        <time_frame>Day 1</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Migraine on the Day After Dosing</title>
          <description>The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment Day and Day 1 is the day after dosing.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</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="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8"/>
                    <measurement group_id="O2" value="28.6"/>
                    <measurement group_id="O3" value="42.3"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Monthly Acute Medication Days</title>
        <description>An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Monthly Acute Medication Days</title>
          <description>An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>Acute Medication Migraine Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="4.62"/>
                    <measurement group_id="O2" value="-3.3" spread="4.89"/>
                    <measurement group_id="O3" value="-1.9" spread="4.18"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.88</ci_lower_limit>
            <ci_upper_limit>-0.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.66</ci_lower_limit>
            <ci_upper_limit>-0.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline of Headache Impact Test (HIT-6) Score</title>
        <description>The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact).</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of Headache Impact Test (HIT-6) Score</title>
          <description>The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact).</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.3" lower_limit="-40" upper_limit="10"/>
                    <measurement group_id="O2" value="-6.2" lower_limit="-34" upper_limit="10"/>
                    <measurement group_id="O3" value="-4.5" lower_limit="-32" upper_limit="15"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.91</ci_lower_limit>
            <ci_upper_limit>-1.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0010</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.76</ci_lower_limit>
            <ci_upper_limit>-0.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Migraine Prevalence From Baseline to Week 4</title>
        <description>The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Migraine Prevalence From Baseline to Week 4</title>
          <description>The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percentage of participants with migraine</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.8" lower_limit="-32.10" upper_limit="-27.49"/>
                    <measurement group_id="O2" value="-27.1" lower_limit="-29.35" upper_limit="-24.78"/>
                    <measurement group_id="O3" value="-18.8" lower_limit="-21.06" upper_limit="-16.54"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Repeated Measures Model</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.22</ci_lower_limit>
            <ci_upper_limit>-7.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Repeated Measures Model</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.48</ci_lower_limit>
            <ci_upper_limit>-5.05</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>75% Headache Responder Rate</title>
        <description>Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>75% Headache Responder Rate</title>
          <description>Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</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="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>50% Headache Responder Rate</title>
        <description>Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>50% Headache Responder Rate</title>
          <description>Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</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="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="150"/>
                    <measurement group_id="O3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>100% Migraine Responder Rate</title>
        <description>For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>100% Migraine Responder Rate</title>
          <description>For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1"/>
                    <measurement group_id="O2" value="10.8"/>
                    <measurement group_id="O3" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>100% Headache Responder Rate</title>
        <description>For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>100% Headache Responder Rate</title>
          <description>For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>Percent of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="2.0"/>
                    <measurement group_id="O3" value="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Monthly Migraine Days (Weeks 13-24)</title>
        <description>Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.</description>
        <time_frame>Week 13-24</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Monthly Migraine Days (Weeks 13-24)</title>
          <description>Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>Migraine Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" spread="6.72"/>
                    <measurement group_id="O2" value="-8.3" spread="7.03"/>
                    <measurement group_id="O3" value="-6.4" spread="7.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Monthly Headache Days (Weeks 1-12)</title>
        <description>Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Monthly Headache Days (Weeks 1-12)</title>
          <description>Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>Headache Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.8" spread="6.10"/>
                    <measurement group_id="O2" value="-8.2" spread="5.78"/>
                    <measurement group_id="O3" value="-6.4" spread="5.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Migraine After Dosing</title>
        <description>The time to first migraine after dosing based upon the migraine data entered into the eDiary</description>
        <time_frame>32 weeks</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Migraine After Dosing</title>
          <description>The time to first migraine after dosing based upon the migraine data entered into the eDiary</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="1.0" upper_limit="11.0"/>
                    <measurement group_id="O2" value="4.0" lower_limit="1.0" upper_limit="9.0"/>
                    <measurement group_id="O3" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication</title>
        <description>The percentage of migraines with acute medication usage. Participants with no migraine will be included with a rate of zero.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication</title>
          <description>The percentage of migraines with acute medication usage. Participants with no migraine will be included with a rate of zero.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percentage of acute medication migraines</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.10" spread="28.86"/>
                    <measurement group_id="O2" value="-9.79" spread="26.78"/>
                    <measurement group_id="O3" value="-2.82" spread="20.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication</title>
        <description>The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication</title>
          <description>The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percentage of acute medication headaches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.46" spread="23.32"/>
                    <measurement group_id="O2" value="-3.08" spread="21.31"/>
                    <measurement group_id="O3" value="-0.16" spread="19.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Frequency of Migraine Days - Week 1-12</title>
        <description>The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Frequency of Migraine Days - Week 1-12</title>
          <description>The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percent change of migraine days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.5" spread="35.46"/>
                    <measurement group_id="O2" value="-48.6" spread="36.60"/>
                    <measurement group_id="O3" value="-34.5" spread="38.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in Frequency of Headache Days - Week 1-12</title>
        <description>The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Frequency of Headache Days - Week 1-12</title>
          <description>The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percent change of headache days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.1" spread="30.59"/>
                    <measurement group_id="O2" value="-41.2" spread="29.20"/>
                    <measurement group_id="O3" value="-31.4" spread="28.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percentage of Severe Migraines</title>
        <description>The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percentage of Severe Migraines</title>
          <description>The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percentage of migraines scored &quot;severe&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.17" spread="27.90"/>
                    <measurement group_id="O2" value="-16.39" spread="26.17"/>
                    <measurement group_id="O3" value="-10.82" spread="25.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percentage of Severe Headache</title>
        <description>The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percentage of Severe Headache</title>
          <description>The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>percentage of headaches scored &quot;severe&quot;</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.00" spread="22.50"/>
                    <measurement group_id="O2" value="-14.01" spread="20.95"/>
                    <measurement group_id="O3" value="-9.12" spread="22.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Monthly Migraine Hours, Weeks 1-12</title>
        <description>Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Monthly Migraine Hours, Weeks 1-12</title>
          <description>Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>migraine hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-80.9" spread="89.17"/>
                    <measurement group_id="O2" value="-75.2" spread="90.40"/>
                    <measurement group_id="O3" value="-52.8" spread="101.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Monthly Headache Hours, Weeks 1-12</title>
        <description>Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.</description>
        <time_frame>Week 1-12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Monthly Headache Hours, Weeks 1-12</title>
          <description>Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>headache hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.5" spread="88.85"/>
                    <measurement group_id="O2" value="-74.6" spread="84.57"/>
                    <measurement group_id="O3" value="-54.8" spread="97.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Migraine-Free Intervals</title>
        <description>The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded.</description>
        <time_frame>32 weeks</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Migraine-Free Intervals</title>
          <description>The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</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="350"/>
                <count group_id="O2" value="356"/>
                <count group_id="O3" value="366"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;= 7 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="132"/>
                    <measurement group_id="O2" value="146"/>
                    <measurement group_id="O3" value="226"/>
                  </measurement_list>
                </category>
                <category>
                  <title>8-14 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="95"/>
                    <measurement group_id="O3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>15-21 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;21 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="73"/>
                    <measurement group_id="O3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores</title>
        <description>The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores</title>
          <description>The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="338"/>
                <count group_id="O2" value="343"/>
                <count group_id="O3" value="343"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Functioning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="6.22"/>
                    <measurement group_id="O2" value="2.6" spread="5.98"/>
                    <measurement group_id="O3" value="1.5" spread="6.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="8.46"/>
                    <measurement group_id="O2" value="4.6" spread="8.53"/>
                    <measurement group_id="O3" value="3.6" spread="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodily Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="8.71"/>
                    <measurement group_id="O2" value="5.1" spread="9.12"/>
                    <measurement group_id="O3" value="4.0" spread="8.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="7.45"/>
                    <measurement group_id="O2" value="2.3" spread="6.89"/>
                    <measurement group_id="O3" value="0.7" spread="7.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vitality</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="9.02"/>
                    <measurement group_id="O2" value="4.2" spread="8.84"/>
                    <measurement group_id="O3" value="2.3" spread="8.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGIC) at Week 12</title>
        <description>The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.</description>
        <time_frame>Week 12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGIC) at Week 12</title>
          <description>The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.</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="337"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="343"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="126"/>
                    <measurement group_id="O3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimally Improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="82"/>
                    <measurement group_id="O3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="69"/>
                    <measurement group_id="O3" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimally Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very Much Worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <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>Health Related Quality of Life (EQ-5D-5L) at Week 12</title>
        <description>The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.</description>
        <time_frame>Week 12</time_frame>
        <population>Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>300 mg ALD403</title>
            <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O2">
            <title>100 mg ALD403</title>
            <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life (EQ-5D-5L) at Week 12</title>
          <description>The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.</description>
          <population>Full Analysis Population - all randomized participants who received investigational product or placebo. The Week 12 scores only include participants who completed the Week 12 visit.</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="338"/>
                <count group_id="O2" value="344"/>
                <count group_id="O3" value="343"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobility</title>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="289"/>
                    <measurement group_id="O2" value="289"/>
                    <measurement group_id="O3" value="298"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slight Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-care</title>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="320"/>
                    <measurement group_id="O2" value="337"/>
                    <measurement group_id="O3" value="331"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slight Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual Activities</title>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="227"/>
                    <measurement group_id="O2" value="233"/>
                    <measurement group_id="O3" value="241"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slight Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort</title>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="121"/>
                    <measurement group_id="O3" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slight Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="127"/>
                    <measurement group_id="O3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression</title>
              <category_list>
                <category>
                  <title>No problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="220"/>
                    <measurement group_id="O2" value="227"/>
                    <measurement group_id="O3" value="219"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Slight Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme Problems</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to Week 32 (end of study)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>300 mg ALD403</title>
          <description>Participants received a single 300 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
        </group>
        <group group_id="E2">
          <title>100 mg ALD403</title>
          <description>Participants received a single 100 mg IV infusion of ALD403 on Days 0 and 84 (Week 12).</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants received a single placebo IV infusion on Days 0 and 84 (Week 12).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>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="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Migraine With Aura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression Suicidal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menometrorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>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="52" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="42" subjects_at_risk="366"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="366"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="350"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="356"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="366"/>
              </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/NCT02974153
org study id: ALD403-CLIN-011
nct id: NCT02974153
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of
      migraine headache in chronic migraineurs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Monthly Migraine Days
time frame: Week 1-12
description: Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12
measure: 75% Migraine Responder Rate
time frame: Week 1-12
description: Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
measure: 75% Migraine Responder Rate - 4 Week
time frame: Week 1-4
description: Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 4, as compared with baseline.
measure: 50% Migraine Responder Rate
time frame: Week 1-12
description: Participants with an average reduction in migraine days of at least 50% over Weeks 1 to 12, as compared with baseline.
measure: Percentage of Participants With a Migraine on the Day After Dosing
time frame: Day 1
description: The percentage of participants with a migraine on the day after dosing, where Day 0 is treatment Day and Day 1 is the day after dosing.
measure: Change in Monthly Acute Medication Days
time frame: Week 1-12
description: An acute medication migraine day was a day with any triptan or ergotamine use as recorded in the eDiary.
measure: Change From Baseline of Headache Impact Test (HIT-6) Score
time frame: Baseline to Week 12
description: The HIT-6 measures the impact of headache on the participant's functional health and well-being in 6 domains: pain; role functioning (ability to carry out usual activities); social functioning; energy or fatigue; cognition; and emotional distress assessed over the prior 12-week period. The total possible scores range from 36 (no impact) to 78 (worst impact).
measure: Change in Migraine Prevalence From Baseline to Week 4
time frame: Baseline to Week 4
description: The avarage change in percentage of participants with a migraine on any given day during baseline and the equivalent avarage rate over Weeks 1-4.
measure: 75% Headache Responder Rate
time frame: Week 1-12
description: Participants with an average reduction in headache days of at least 75% over Weeks 1 to 12, as compared with baseline.
measure: 50% Headache Responder Rate
time frame: Week 1-12
description: Participants with an average reduction in headache days of at least 50% over Weeks 1 to 12, as compared with baseline.
measure: 100% Migraine Responder Rate
time frame: Week 1-12
description: For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.
measure: 100% Headache Responder Rate
time frame: Week 1-12
description: For each 4-week period the 100% response is determined, and the result for a participant is the average rate across Weeks 1-12. If a participant has one 4-week period out of 3 with 100% response, they are included as 33%.
measure: Change From Baseline in Monthly Migraine Days (Weeks 13-24)
time frame: Week 13-24
description: Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 13-24.
measure: Change From Baseline in Monthly Headache Days (Weeks 1-12)
time frame: Week 1-12
description: Monthly headache days are summarized in 28-day intervals, and averaged across Weeks 1-12.
measure: Time to First Migraine After Dosing
time frame: 32 weeks
description: The time to first migraine after dosing based upon the migraine data entered into the eDiary
measure: Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication
time frame: Week 1-12
description: The percentage of migraines with acute medication usage. Participants with no migraine will be included with a rate of zero.
measure: Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication
time frame: Week 1-12
description: The percentage of headaches with acute medication usage. Participants with no headaches will be included with a rate of zero.
measure: Percent Change in Frequency of Migraine Days - Week 1-12
time frame: Week 1-12
description: The percent change in frequency of migraine days from Weeks 1-12 was calculated as the number of migraine days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of migraine days over Weeks 1-12.
measure: Percent Change in Frequency of Headache Days - Week 1-12
time frame: Week 1-12
description: The percent change in frequency of headache days from Weeks 1-12 was calculated as the number of headache days within 4-week intervals that were then averaged up to Week 12. The difference of this estimate from baseline was calculated as the change from baseline in the frequency of headache days over Weeks 1-12.
measure: Change From Baseline in Percentage of Severe Migraines
time frame: Week 1-12
description: The change from baseline in percentage of migraines that are classified as severe over Weeks 1-12.
measure: Change From Baseline in Percentage of Severe Headache
time frame: Week 1-12
description: The change from baseline in percentage of headaches that are classified as severe over Weeks 1-12.
measure: Change From Baseline in Monthly Migraine Hours, Weeks 1-12
time frame: Week 1-12
description: Migraine hours are the sum of migraines within 4 week intervals, and the average 4 week duration within 12 weeks.
measure: Change From Baseline in Monthly Headache Hours, Weeks 1-12
time frame: Week 1-12
description: Headache hours are the sum of the duration of headaches within 4 week intervals, and the average 4 week duration within 12 week intervals.
measure: Duration of Migraine-Free Intervals
time frame: 32 weeks
description: The number of participants with migraine-free intervals starting within the first 2 weeks of treatment. The longest migraine free interval for each participant is recorded.
measure: Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores
time frame: Baseline to Week 12
description: The SF-36 is a health survey containing 36 questions consisting of eight scaled scores to measure quality of life over the past 4 weeks. All scales are on a range of 0 to 100, with 0 being the worst and 100 being the best. Scales are reported separately. Increases from baseline indicate improvement.
measure: Patient Global Impression of Change (PGIC) at Week 12
time frame: Week 12
description: The PGIC includes a single question concerning the participant's impression of the change in their disease status since the start of the study. Seven responses are possible: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse.
measure: Health Related Quality of Life (EQ-5D-5L) at Week 12
time frame: Week 12
description: The EQ-5D-5L is a descriptive system of health-related quality of life states consisting of 5 dimensions/questions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses. The responses record five levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension.
arm group label: ALD403 (Eptinezumab) Dose Level 1
arm group type: Experimental
description: ALD403 (Eptinezumab) Dose Level 1 (IV)
arm group label: ALD403 (Eptinezumab) Dose Level 2
arm group type: Experimental
description: ALD403 (Eptinezumab) Dose Level 2 (IV)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (IV)
intervention type: Biological
intervention name: ALD403 (Eptinezumab)
arm group label: ALD403 (Eptinezumab) Dose Level 1
arm group label: ALD403 (Eptinezumab) Dose Level 2
other name: Eptinezumab-jjmr
other name: Vyepti
intervention type: Biological
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
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country: Belgium
country: Czechia
country: Denmark
country: Georgia
country: Germany
country: Hungary
country: Italy
country: Russian Federation
country: Slovakia
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Migraine Disorders
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