<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/NCT01723514</url>
  </required_header>
  <id_info>
    <org_study_id>20101268</org_study_id>
    <secondary_id>2012-003594-26</secondary_id>
    <nct_id>NCT01723514</nct_id>
  </id_info>
  <brief_title>Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients</brief_title>
  <official_title>Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 334 in Healthy Subjects and in Migraine Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amgen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to determine whether erenumab is safe and well tolerated&#xD;
      in healthy adults and migraine patients. As part of the secondary objectives, this study will&#xD;
      be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple&#xD;
      subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize&#xD;
      the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple&#xD;
      SC doses in healthy adults and migraine patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2012</start_date>
  <completion_date type="Actual">July 10, 2014</completion_date>
  <primary_completion_date type="Actual">July 10, 2014</primary_completion_date>
  <phase>Phase 1</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>Number of Participants With Adverse Events</measure>
    <time_frame>From first dose of study drug until a maximum of 168 days after last dose (225 days)</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.&#xD;
Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.&#xD;
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:&#xD;
fatal&#xD;
life-threatening (places the subject at immediate risk of death)&#xD;
requires in-patient hospitalization or prolongation of existing hospitalization&#xD;
results in persistent or significant disability/incapacity&#xD;
congenital anomaly/birth defect&#xD;
other medically important serious event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>From first dose of study drug until a maximum of 168 days after last dose (225 days)</time_frame>
    <description>The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Developed Anti-erenumab Antibodies</measure>
    <time_frame>From first dose of study drug until a maximum of 168 days after last dose (225 days)</time_frame>
    <description>Participants who had a negative or no result at baseline and were antibody positive postbaseline.&#xD;
Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of Erenumab</measure>
    <time_frame>Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)</time_frame>
    <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Observed Concentration (Tmax) of Erenumab</measure>
    <time_frame>Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)</time_frame>
    <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)</measure>
    <time_frame>Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)</time_frame>
    <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>Day 57 (assessed from predose to day 225))</time_frame>
    <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow</measure>
    <time_frame>Baseline, Days 8, 57, 85, 113, 169 and 197</time_frame>
    <description>Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.&#xD;
Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.&#xD;
According to the protocol, not all cohorts had dermal blood flow measurements at all time points.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Erenumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Erenumab</intervention_name>
    <description>Administered by subcutaneous injection once a month</description>
    <arm_group_label>Erenumab</arm_group_label>
    <other_name>AMG-334</other_name>
    <other_name>Aimovig™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered by subcutaneous injection once a month</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy male and female subjects, as well as male or female subjects with migraines between&#xD;
        18 and 55 years of age, inclusive, with no history or evidence of clinically relevant&#xD;
        medical disorders as determined by the investigator in consultation with the Amgen&#xD;
        physician;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - History or evidence of clinically significant disorder (including psychiatric), condition&#xD;
        or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to&#xD;
        subject safety or interfere with the study evaluation, procedures, or completion;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MD</last_name>
    <role>Study Director</role>
    <affiliation>Amgen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.amgentrials.com</url>
    <description>AmgenTrials clinical trials website</description>
  </link>
  <reference>
    <citation>de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.</citation>
    <PMID>28736918</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <results_first_submitted>June 11, 2018</results_first_submitted>
  <results_first_submitted_qc>August 1, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2019</results_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erenumab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study enrolled healthy participants (Part A) and participants with onset of migraines before the age of 50 years, with or without aura for at least 6 months and 3 migraine attacks per month in the last 3 months (Part B). The study was conducted at a single center in Belgium.</recruitment_details>
      <pre_assignment_details>Healthy participants were randomized to 1 of 4 cohorts and migraine patients were randomized to 1 of 2 cohorts. Within each cohort participants were assigned to erenumab or placebo in a 3:1 ratio.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Healthy: Placebo</title>
          <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
        </group>
        <group group_id="P2">
          <title>Healthy: Erenumab 21 mg</title>
          <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="P3">
          <title>Healthy: Erenumab 70 mg</title>
          <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="P4">
          <title>Healthy: Erenumab 140 mg</title>
          <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="P5">
          <title>Healthy: Erenumab 280/210 mg</title>
          <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
        </group>
        <group group_id="P6">
          <title>Migraine: Placebo</title>
          <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="P7">
          <title>Migraine: Erenumab 21 mg</title>
          <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="P8">
          <title>Migraine: Erenumab 140 mg</title>
          <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy: Placebo</title>
          <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
        </group>
        <group group_id="B2">
          <title>Healthy: Erenumab 21 mg</title>
          <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="B3">
          <title>Healthy: Erenumab 70 mg</title>
          <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="B4">
          <title>Healthy: Erenumab 140 mg</title>
          <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="B5">
          <title>Healthy: Erenumab 280/210 mg</title>
          <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
        </group>
        <group group_id="B6">
          <title>Migraine: Placebo</title>
          <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="B7">
          <title>Migraine: Erenumab 21 mg</title>
          <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="B8">
          <title>Migraine: Erenumab 140 mg</title>
          <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="B9">
          <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="8"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="4"/>
            <count group_id="B7" value="6"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Data are reported separately for each part of the study.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Healthy Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="6"/>
                    <count group_id="B6" value="0"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="0"/>
                    <count group_id="B9" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.1" spread="13.0"/>
                    <measurement group_id="B2" value="26.3" spread="5.7"/>
                    <measurement group_id="B3" value="33.3" spread="14.1"/>
                    <measurement group_id="B4" value="29.8" spread="8.6"/>
                    <measurement group_id="B5" value="39.0" spread="13.8"/>
                    <measurement group_id="B9" value="32.1" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Migraine Participants</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="6"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B6" value="37.0" spread="11.9"/>
                    <measurement group_id="B7" value="31.7" spread="11.0"/>
                    <measurement group_id="B8" value="31.3" spread="12.6"/>
                    <measurement group_id="B9" value="32.9" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="6"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="6"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</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="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="8"/>
                    <count group_id="B2" value="6"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="6"/>
                    <count group_id="B5" value="6"/>
                    <count group_id="B6" value="4"/>
                    <count group_id="B7" value="6"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="48"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.&#xD;
Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.&#xD;
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:&#xD;
fatal&#xD;
life-threatening (places the subject at immediate risk of death)&#xD;
requires in-patient hospitalization or prolongation of existing hospitalization&#xD;
results in persistent or significant disability/incapacity&#xD;
congenital anomaly/birth defect&#xD;
other medically important serious event.</description>
        <time_frame>From first dose of study drug until a maximum of 168 days after last dose (225 days)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.&#xD;
Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.&#xD;
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:&#xD;
fatal&#xD;
life-threatening (places the subject at immediate risk of death)&#xD;
requires in-patient hospitalization or prolongation of existing hospitalization&#xD;
results in persistent or significant disability/incapacity&#xD;
congenital anomaly/birth defect&#xD;
other medically important serious event.</description>
          <population>All participants who received at least 1 dose of study drug.</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="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE leading to discontinuation of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE leading to discontinuation from study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related serious adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TRAE leading to discontinuation of study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TRAE leading to discontinuation from study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.</description>
        <time_frame>From first dose of study drug until a maximum of 168 days after last dose (225 days)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.</description>
          <population>All participants who received at least 1 dose of study drug.</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="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Suicidal Ideation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suicidal Behavior</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Developed Anti-erenumab Antibodies</title>
        <description>Participants who had a negative or no result at baseline and were antibody positive postbaseline.&#xD;
Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.</description>
        <time_frame>From first dose of study drug until a maximum of 168 days after last dose (225 days)</time_frame>
        <population>All participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Developed Anti-erenumab Antibodies</title>
          <description>Participants who had a negative or no result at baseline and were antibody positive postbaseline.&#xD;
Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.</description>
          <population>All participants who received at least 1 dose of study drug.</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="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Binding antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutralizing antibodies</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) of Erenumab</title>
        <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
        <time_frame>Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)</time_frame>
        <population>All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) of Erenumab</title>
          <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
          <population>All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
          <units>μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.15" spread="0.914"/>
                    <measurement group_id="O3" value="6.26" spread="2.55"/>
                    <measurement group_id="O4" value="13.8" spread="4.00"/>
                    <measurement group_id="O5" value="24.9" spread="4.90"/>
                    <measurement group_id="O7" value="1.76" spread="0.741"/>
                    <measurement group_id="O8" value="11.0" spread="3.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.60" spread="0.952"/>
                    <measurement group_id="O3" value="9.63" spread="3.60"/>
                    <measurement group_id="O4" value="23.7" spread="7.89"/>
                    <measurement group_id="O5" value="36.3" spread="6.18"/>
                    <measurement group_id="O7" value="2.00" spread="0.552"/>
                    <measurement group_id="O8" value="18.4" spread="5.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Observed Concentration (Tmax) of Erenumab</title>
        <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
        <time_frame>Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)</time_frame>
        <population>All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Observed Concentration (Tmax) of Erenumab</title>
          <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
          <population>All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.0" lower_limit="3.0" upper_limit="6.9"/>
                    <measurement group_id="O3" value="4.0" lower_limit="3.0" upper_limit="11"/>
                    <measurement group_id="O4" value="5.9" lower_limit="3.1" upper_limit="13"/>
                    <measurement group_id="O5" value="6.9" lower_limit="3.0" upper_limit="6.9"/>
                    <measurement group_id="O7" value="6.9" lower_limit="4.0" upper_limit="7.0"/>
                    <measurement group_id="O8" value="11" lower_limit="4.0" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6.9" lower_limit="5.9" upper_limit="7.9"/>
                    <measurement group_id="O3" value="7.9" lower_limit="6.9" upper_limit="14"/>
                    <measurement group_id="O4" value="6.9" lower_limit="6.9" upper_limit="8.0"/>
                    <measurement group_id="O5" value="6.9" lower_limit="6.9" upper_limit="8.0"/>
                    <measurement group_id="O7" value="6.9" lower_limit="6.9" upper_limit="7.9"/>
                    <measurement group_id="O8" value="6.9" lower_limit="6.9" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)</title>
        <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
        <time_frame>Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)</time_frame>
        <population>All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)</title>
          <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
          <population>All participants for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
          <units>day*μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="34.7" spread="13.1"/>
                    <measurement group_id="O3" value="124" spread="49.2"/>
                    <measurement group_id="O4" value="281" spread="89.1"/>
                    <measurement group_id="O5" value="486" spread="57.8"/>
                    <measurement group_id="O7" value="28.7" spread="11.0"/>
                    <measurement group_id="O8" value="244" spread="86.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="49.5" spread="20.1"/>
                    <measurement group_id="O3" value="216" spread="82.7"/>
                    <measurement group_id="O4" value="476" spread="161"/>
                    <measurement group_id="O5" value="760" spread="143"/>
                    <measurement group_id="O7" value="37.9" spread="12.5"/>
                    <measurement group_id="O8" value="417" spread="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)</title>
        <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
        <time_frame>Day 57 (assessed from predose to day 225))</time_frame>
        <population>All participants who received erenumab and for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)</title>
          <description>Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).</description>
          <population>All participants who received erenumab and for whom at least 1 pharmacokinetic parameter or endpoint was adequately estimated and with available data at each time point.</population>
          <units>day*μg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="59.3" spread="27.8"/>
                    <measurement group_id="O3" value="342" spread="144"/>
                    <measurement group_id="O4" value="848" spread="376"/>
                    <measurement group_id="O5" value="1410" spread="332"/>
                    <measurement group_id="O7" value="45.0" spread="15.7"/>
                    <measurement group_id="O8" value="773" spread="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow</title>
        <description>Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.&#xD;
Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.&#xD;
According to the protocol, not all cohorts had dermal blood flow measurements at all time points.</description>
        <time_frame>Baseline, Days 8, 57, 85, 113, 169 and 197</time_frame>
        <population>All participants for whom at least 1 postdose capsaicin response measure was recorded. Measurement and analysis of dermal blood flow were not performed in the 280/210 cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>Healthy: Placebo</title>
            <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
          </group>
          <group group_id="O2">
            <title>Healthy: Erenumab 21 mg</title>
            <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O3">
            <title>Healthy: Erenumab 70 mg</title>
            <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O4">
            <title>Healthy: Erenumab 140 mg</title>
            <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O5">
            <title>Healthy: Erenumab 280/210 mg</title>
            <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
          </group>
          <group group_id="O6">
            <title>Migraine: Placebo</title>
            <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O7">
            <title>Migraine: Erenumab 21 mg</title>
            <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
          <group group_id="O8">
            <title>Migraine: Erenumab 140 mg</title>
            <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow</title>
          <description>Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.&#xD;
Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.&#xD;
According to the protocol, not all cohorts had dermal blood flow measurements at all time points.</description>
          <population>All participants for whom at least 1 postdose capsaicin response measure was recorded. Measurement and analysis of dermal blood flow were not performed in the 280/210 cohort.</population>
          <units>ratio</units>
          <param>Geometric Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.24" spread="1.20"/>
                    <measurement group_id="O2" value="9.28" spread="1.21"/>
                    <measurement group_id="O3" value="8.92" spread="1.20"/>
                    <measurement group_id="O4" value="8.90" spread="1.22"/>
                    <measurement group_id="O6" value="13.27" spread="1.37"/>
                    <measurement group_id="O7" value="11.08" spread="1.29"/>
                    <measurement group_id="O8" value="11.70" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.53" spread="1.20"/>
                    <measurement group_id="O2" value="1.76" spread="1.21"/>
                    <measurement group_id="O3" value="2.46" spread="1.20"/>
                    <measurement group_id="O4" value="1.75" spread="1.22"/>
                    <measurement group_id="O6" value="13.20" spread="1.37"/>
                    <measurement group_id="O7" value="2.64" spread="1.29"/>
                    <measurement group_id="O8" value="1.64" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.75" spread="1.20"/>
                    <measurement group_id="O2" value="1.87" spread="1.21"/>
                    <measurement group_id="O3" value="1.82" spread="1.20"/>
                    <measurement group_id="O4" value="1.90" spread="1.22"/>
                    <measurement group_id="O6" value="12.30" spread="1.37"/>
                    <measurement group_id="O7" value="2.48" spread="1.29"/>
                    <measurement group_id="O8" value="2.01" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.61" spread="1.20"/>
                    <measurement group_id="O2" value="2.71" spread="1.21"/>
                    <measurement group_id="O3" value="1.63" spread="1.20"/>
                    <measurement group_id="O4" value="1.80" spread="1.22"/>
                    <measurement group_id="O6" value="13.33" spread="1.37"/>
                    <measurement group_id="O7" value="2.40" spread="1.29"/>
                    <measurement group_id="O8" value="2.08" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 113</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="6"/>
                    <count group_id="O8" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.11" spread="1.33"/>
                    <measurement group_id="O2" value="7.48" spread="1.21"/>
                    <measurement group_id="O6" value="3.50" spread="1.51"/>
                    <measurement group_id="O7" value="5.00" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 169</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.72" spread="1.24"/>
                    <measurement group_id="O3" value="10.06" spread="1.20"/>
                    <measurement group_id="O4" value="5.78" spread="1.22"/>
                    <measurement group_id="O6" value="14.78" spread="1.51"/>
                    <measurement group_id="O8" value="4.64" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.20" spread="1.33"/>
                    <measurement group_id="O4" value="8.16" spread="1.22"/>
                    <measurement group_id="O6" value="18.52" spread="1.51"/>
                    <measurement group_id="O8" value="8.46" spread="1.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-79.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-87.54</ci_lower_limit>
            <ci_upper_limit>-65.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-71.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-82.67</ci_lower_limit>
            <ci_upper_limit>-52.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-79.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-88.29</ci_lower_limit>
            <ci_upper_limit>-64.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-72.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-83.32</ci_lower_limit>
            <ci_upper_limit>-54.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-73.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-83.79</ci_lower_limit>
            <ci_upper_limit>-55.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-71.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-83.93</ci_lower_limit>
            <ci_upper_limit>-50.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-68.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-81.01</ci_lower_limit>
            <ci_upper_limit>-47.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-81.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-88.62</ci_lower_limit>
            <ci_upper_limit>-68.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-79.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-88.02</ci_lower_limit>
            <ci_upper_limit>-63.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.25</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-32.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-65.71</ci_lower_limit>
            <ci_upper_limit>32.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.90</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>3.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.78</ci_lower_limit>
            <ci_upper_limit>80.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.091</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-40.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-67.50</ci_lower_limit>
            <ci_upper_limit>8.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.73</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>13.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-44.39</ci_lower_limit>
            <ci_upper_limit>130.94</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-80.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-91.53</ci_lower_limit>
            <ci_upper_limit>-52.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Day 8: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-87.60</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-94.53</ci_lower_limit>
            <ci_upper_limit>-71.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Rratio</param_type>
            <param_value>-79.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-91.44</ci_lower_limit>
            <ci_upper_limit>-52.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Day 57: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-83.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-92.79</ci_lower_limit>
            <ci_upper_limit>-62.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-81.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-92.35</ci_lower_limit>
            <ci_upper_limit>-57.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Day 85: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-84.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-93.12</ci_lower_limit>
            <ci_upper_limit>-64.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O7</group_id>
            </group_id_list>
            <groups_desc>Day 113: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.47</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>43.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.06</ci_lower_limit>
            <ci_upper_limit>286.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Day 169: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.020</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-68.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-88.02</ci_lower_limit>
            <ci_upper_limit>-17.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O6</group_id>
              <group_id>O8</group_id>
            </group_id_list>
            <groups_desc>Day 197: A repeated measures ANCOVA was performed for the ratio of blood flow measures at 30 minutes post capsaicin challenge to pre capsaicin challenge. The model included treatment, day, and the treatment by day interaction as independent variables, and both the 0 minute pre-capsaicin blood flow measure as well as the day 0, 30-minute post-capsaicin blood flow measures on day -1 .</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.11</p_value>
            <method>Repeated Measures ANCOVA</method>
            <param_type>LS Geometric Mean Ratio</param_type>
            <param_value>-54.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-82.58</ci_lower_limit>
            <ci_upper_limit>19.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug until a maximum of 168 days after last dose (225 days).</time_frame>
      <desc>Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.</desc>
      <group_list>
        <group group_id="E1">
          <title>Healthy: Placebo</title>
          <description>Healthy participants received placebo subcutaneous injection on Days 1, 29, and 57.</description>
        </group>
        <group group_id="E2">
          <title>Healthy: Erenumab 21 mg</title>
          <description>Healthy participants received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="E3">
          <title>Healthy: Erenumab 70 mg</title>
          <description>Healthy participants received 70 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="E4">
          <title>Healthy: Erenumab 140 mg</title>
          <description>Healthy participants received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="E5">
          <title>Healthy: Erenumab 280/210 mg</title>
          <description>Healthy participants received 280 mg erenumab by subcutaneous injection on day 1, and 210 mg erenumab on days 29 and 57.</description>
        </group>
        <group group_id="E6">
          <title>Migraine: Placebo</title>
          <description>Participants with migraine received placebo by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="E7">
          <title>Migraine: Erenumab 21 mg</title>
          <description>Participants with migraine received 21 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
        <group group_id="E8">
          <title>Migraine: Erenumab 140 mg</title>
          <description>Participants with migraine received 140 mg erenumab by subcutaneous injection on days 1, 29 and 57.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.0</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="5" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tongue discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood immunoglobulin E increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
              </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>The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Amgen Inc.</organization>
      <phone>866-572-6436</phone>
    </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/NCT01723514
org study id: 20101268
secondary id: 2012-003594-26
nct id: NCT01723514
lead sponsor: 
has dmc: No
The primary purpose of this study is to determine whether erenumab is safe and well tolerated
      in healthy adults and migraine patients. As part of the secondary objectives, this study will
      be conducted to characterize the pharmacokinetic (PK) profile of erenumab after multiple
      subcutaneous (SC) doses in healthy adults and migraine patients, as well as to characterize
      the effect of erenumab on the capsaicin induced increase in dermal blood flow after multiple
      SC doses in healthy adults and migraine patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Adverse Events
time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
description: An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. The definition of adverse events includes worsening of a pre-existing medical condition. Laboratory value changes that require treatment or adjustment in current therapy are considered adverse events.
Teatment-related adverse events (TRAEs) are those assessed by the investigator as being possibly related to study drug.
A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria:
fatal
life-threatening (places the subject at immediate risk of death)
requires in-patient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event.
measure: Number of Participants With Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
description: The C-SSRS is a measure of suicidal ideation and behavior. Ideation includes a wish to be dead or nonspecific thoughts about wanting to end life. Suicidal behavior includes actual attempts, interrupted or aborted attempts, and any preparatory acts.
measure: Number of Participants Who Developed Anti-erenumab Antibodies
time frame: From first dose of study drug until a maximum of 168 days after last dose (225 days)
description: Participants who had a negative or no result at baseline and were antibody positive postbaseline.
Blood samples were first tested for anti-erenumab binding antibodies, samples testing positive for binding antibodies were also tested for neutralizing antibodies.
measure: Maximum Observed Serum Concentration (Cmax) of Erenumab
time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
description: Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
measure: Time to Maximum Observed Concentration (Tmax) of Erenumab
time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
description: Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
measure: Area Under the Serum Concentration-Time Curve From 0 to 28 Days (AUC0-28day)
time frame: Day 1 (assessed from predose to day 28) and day 57 (assessed from predose up to day 225)
description: Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
measure: Area Under the Serum Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
time frame: Day 57 (assessed from predose to day 225))
description: Serum concentration of erenumab was analyzed using an enzyme-linked immunosorbent assay (ELISA).
measure: Ratio of Post-capsaicin Dermal Blood Flow to Pre-capsaicin Dermal Blood Flow
time frame: Baseline, Days 8, 57, 85, 113, 169 and 197
description: Inhibition of capsaicin-induced dermal blood flow (DBF) by erenumab was used to measure calcitonin gene-related peptide (CGRP) receptor antagonism. Capsaicin was applied at 2 sites on the volar surface of the participants' left or right forearms and a control mixture was applied to 1 site on the volar surface of either the participants' left or right forearm. Dermal blood flow was assessed by laser Doppler perfusion imaging and was done immediately before ('baseline') and 0.5 hours post-capsaicin on the surface of these 3 sites.
Data reported are the least square geometric mean ratios for the post-capsaicin dermal blood flow to pre-capsaicin dermal blood flow.
According to the protocol, not all cohorts had dermal blood flow measurements at all time points.
arm group label: Erenumab
arm group type: Experimental
description: Healthy participants and participants with migraine received subcutaneous doses of erenumab on days 1, 29 and 57.
arm group label: Placebo
arm group type: Placebo Comparator
description: Healthy participants and participants with migraine received subcutaneous doses of placebo on days 1, 29 and 57.
intervention type: Drug
intervention name: Erenumab
description: Administered by subcutaneous injection once a month
arm group label: Erenumab
other name: AMG-334
other name: Aimovig™
intervention type: Drug
intervention name: Placebo
description: Administered by subcutaneous injection once a month
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: MD
role: Study Director
affiliation: Amgen
facility: 
country: Belgium
url: http://www.amgentrials.com
description: AmgenTrials clinical trials website
citation: de Hoon J, Van Hecken A, Vandermeulen C, Yan L, Smith B, Chen JS, Bautista E, Hamilton L, Waksman J, Vu T, Vargas G. Phase I, Randomized, Double-blind, Placebo-controlled, Single-dose, and Multiple-dose Studies of Erenumab in Healthy Subjects and Patients With Migraine. Clin Pharmacol Ther. 2018 May;103(5):815-825. doi: 10.1002/cpt.799. Epub 2017 Oct 24.
PMID: 28736918
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Erenumab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 