<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/NCT01723254</url>
  </required_header>
  <id_info>
    <org_study_id>B4901001</org_study_id>
    <secondary_id>ANTI- IGE VACCINE</secondary_id>
    <nct_id>NCT01723254</nct_id>
  </id_info>
  <brief_title>A Study To Assess The Safety And Tolerability Of Different Doses Of PF-06444753 And PF-06444752 In Subjects With Allergic Rhinitis</brief_title>
  <official_title>A Phase 1, Randomized, Double Blinded, Placebo Controlled Study To Evaluate The Safety, Tolerability, Immunogenicity, And Exploratory Pharmacodynamic Response Of Ascending Dose Levels Of An Anti-ige Vaccine With Two Different Adjuvant Formulations (Pf-06444753 And Pf-06444752) In Generally Healthy Subjects With Allergic Rhinitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and tolerability of different doses of&#xD;
      PF-06444753 and PF-06444752 in subjects with allergic rhinitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination</measure>
    <time_frame>Within 14 days</time_frame>
    <description>Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [&gt;] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: &gt;10 cm or 21 caliper units and above).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination</measure>
    <time_frame>Within 14 days</time_frame>
    <description>Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: &gt;2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [&gt;=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs</measure>
    <time_frame>Baseline up to 336 days post study administration or at Early Termination</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Laboratory Test Abnormalities</measure>
    <time_frame>Baseline up to 336 days post last study drug administration or Early Termination</time_frame>
    <description>Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336</measure>
    <time_frame>Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)</time_frame>
    <description>Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Allergic Rhinitis</condition>
  <arm_group>
    <arm_group_label>PF-06444753</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06444752</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intramuscular</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IGE-1</intervention_name>
    <description>Intramuscular, multiple dose</description>
    <arm_group_label>PF-06444753</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IGE-2</intervention_name>
    <description>Intramuscular, multiple dose</description>
    <arm_group_label>PF-06444752</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Saline (0.9% sodium chloride)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy, males or females of non-child bearing potential, who are between 18 and 55&#xD;
             years, inclusive,&#xD;
&#xD;
          -  Intermittent or persistent allergic rhinitis that is associated with perennial or&#xD;
             seasonal allergen reactivity at screening as determined by a positive specific IgE&#xD;
             level ≥1 KU/L to at least one of the following common allergens: dust mite&#xD;
             (Dermatophagoides farinae or Dermatophagoides pteronyssinus), cat, dog, mold&#xD;
             (Alternaria), Bermuda grass, common ragweed, oak, Timothy grass or elm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic&#xD;
             disease that may compromise their ability to safely participate in the study.&#xD;
&#xD;
          -  Evidence or history of clinically significant pulmonary disease (including allergic&#xD;
             and non-allergic asthma, chronic obstructive pulmonary disease [COPD], cystic&#xD;
             fibrosis, bronchiectasis, chronic bronchitis, emphysema, tuberculosis, pulmonary&#xD;
             fibrosis, pulmonary hypertension, or others).&#xD;
&#xD;
          -  Evidence or history of clinically significant autoimmune disease (including rheumatoid&#xD;
             arthritis, systemic lupus erythematosus, ulcerative colitis, or others).&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ottawa Allergy Research Corporation</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diex Research Montreal Inc.</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4N 3C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diex Research Sherbrooke Inc.</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche Appliquee en Allergie de Quebec</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4M6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4901001&amp;StudyName=A%20Study%20To%20Assess%20The%20Safety%20And%20Tolerability%20Of%20Different%20Doses%20Of%20PF-06444753%20And%20PF-06444752%20In%20Subjects%20With%20Allergic%20Rhinitis</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <results_first_submitted>May 31, 2016</results_first_submitted>
  <results_first_submitted_qc>May 31, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 11, 2016</results_first_posted>
  <last_update_submitted>May 31, 2016</last_update_submitted>
  <last_update_submitted_qc>May 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaccines</keyword>
  <keyword>Phase 1</keyword>
  <keyword>Allergic Rhinitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulin E</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IGE-1 6 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="P2">
          <title>IGE-1 20 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="P3">
          <title>IGE-1 60 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="P4">
          <title>IGE-1 200 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="P5">
          <title>IGE-2 20 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="P6">
          <title>IGE-2 60 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="P7">
          <title>IGE-2 200 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="P8">
          <title>Saline Placebo</title>
          <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="20"/>
                <participants group_id="P6" count="20"/>
                <participants group_id="P7" count="20"/>
                <participants group_id="P8" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="18"/>
                <participants group_id="P6" count="18"/>
                <participants group_id="P7" count="19"/>
                <participants group_id="P8" count="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Conflict with work schedule</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Personal issues</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="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer have time to participate</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="1"/>
                <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>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Move/Left to another country/city</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="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>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IGE-1 6 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="B2">
          <title>IGE-1 20 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="B3">
          <title>IGE-1 60 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="B4">
          <title>IGE-1 200 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="B5">
          <title>IGE-2 20 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="B6">
          <title>IGE-2 60 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="B7">
          <title>IGE-2 200 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="B8">
          <title>Saline Placebo</title>
          <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</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="6"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="20"/>
            <count group_id="B5" value="20"/>
            <count group_id="B6" value="20"/>
            <count group_id="B7" value="20"/>
            <count group_id="B8" value="63"/>
            <count group_id="B9" value="190"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36.7" spread="13.3"/>
                    <measurement group_id="B2" value="31.6" spread="8.8"/>
                    <measurement group_id="B3" value="35.7" spread="10.0"/>
                    <measurement group_id="B4" value="33.5" spread="9.3"/>
                    <measurement group_id="B5" value="35.4" spread="9.2"/>
                    <measurement group_id="B6" value="35.9" spread="11.0"/>
                    <measurement group_id="B7" value="33.6" spread="12.0"/>
                    <measurement group_id="B8" value="34.7" spread="8.8"/>
                    <measurement group_id="B9" value="34.4" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="19"/>
                    <measurement group_id="B6" value="18"/>
                    <measurement group_id="B7" value="20"/>
                    <measurement group_id="B8" value="58"/>
                    <measurement group_id="B9" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination</title>
        <description>Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [&gt;] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: &gt;10 cm or 21 caliper units and above).</description>
        <time_frame>Within 14 days</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>IGE-1 6 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O2">
            <title>IGE-1 20 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O3">
            <title>IGE-1 60 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O4">
            <title>IGE-1 200 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O5">
            <title>IGE-2 20 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O6">
            <title>IGE-2 60 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O7">
            <title>IGE-2 200 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O8">
            <title>Saline Placebo</title>
            <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination</title>
          <description>Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [&gt;] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: &gt;10 cm or 21 caliper units and above).</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="20.1" upper_limit="79.9"/>
                    <measurement group_id="O2" value="9.5" lower_limit="2.6" upper_limit="23.4"/>
                    <measurement group_id="O3" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O4" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O5" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O8" value="7.9" lower_limit="3.9" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="20.1" upper_limit="79.9"/>
                    <measurement group_id="O2" value="9.5" lower_limit="2.6" upper_limit="23.4"/>
                    <measurement group_id="O3" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O4" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O5" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O8" value="7.9" lower_limit="3.9" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate and Severe Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="14.3" lower_limit="5.4" upper_limit="29.1"/>
                    <measurement group_id="O3" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O4" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O5" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O8" value="9.5" lower_limit="5.1" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="14.3" lower_limit="5.4" upper_limit="29.1"/>
                    <measurement group_id="O3" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O4" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O5" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O8" value="9.5" lower_limit="5.1" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O4" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O5" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" lower_limit="49.0" upper_limit="98.3"/>
                    <measurement group_id="O2" value="100.0" lower_limit="89.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="90.0" lower_limit="75.5" upper_limit="97.3"/>
                    <measurement group_id="O4" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O5" value="90.0" lower_limit="75.5" upper_limit="97.3"/>
                    <measurement group_id="O6" value="85.0" lower_limit="69.6" upper_limit="94.4"/>
                    <measurement group_id="O7" value="90.0" lower_limit="75.5" upper_limit="97.3"/>
                    <measurement group_id="O8" value="15.9" lower_limit="10.1" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="20.1" upper_limit="79.9"/>
                    <measurement group_id="O2" value="57.1" lower_limit="41.0" upper_limit="72.2"/>
                    <measurement group_id="O3" value="50.0" lower_limit="33.8" upper_limit="66.2"/>
                    <measurement group_id="O4" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O5" value="80.0" lower_limit="63.9" upper_limit="91.0"/>
                    <measurement group_id="O6" value="75.0" lower_limit="58.5" upper_limit="87.3"/>
                    <measurement group_id="O7" value="60.0" lower_limit="43.3" upper_limit="75.1"/>
                    <measurement group_id="O8" value="14.3" lower_limit="8.8" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="9.3" upper_limit="66.7"/>
                    <measurement group_id="O2" value="38.1" lower_limit="23.6" upper_limit="54.4"/>
                    <measurement group_id="O3" value="40.0" lower_limit="24.9" upper_limit="56.7"/>
                    <measurement group_id="O4" value="70.0" lower_limit="53.3" upper_limit="83.4"/>
                    <measurement group_id="O5" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O8" value="1.6" lower_limit="0.2" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="4.8" lower_limit="0.5" upper_limit="17.3"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Local Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3" lower_limit="49.0" upper_limit="98.3"/>
                    <measurement group_id="O2" value="100.0" lower_limit="89.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="90.0" lower_limit="75.5" upper_limit="97.3"/>
                    <measurement group_id="O4" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O5" value="95.0" lower_limit="81.9" upper_limit="99.5"/>
                    <measurement group_id="O6" value="85.0" lower_limit="69.6" upper_limit="94.4"/>
                    <measurement group_id="O7" value="90.0" lower_limit="75.5" upper_limit="97.3"/>
                    <measurement group_id="O8" value="25.4" lower_limit="18.3" upper_limit="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Severe Local Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="4.8" lower_limit="0.5" upper_limit="17.3"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination</title>
        <description>Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: &gt;2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [&gt;=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).</description>
        <time_frame>Within 14 days</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>IGE-1 6 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O2">
            <title>IGE-1 20 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O3">
            <title>IGE-1 60 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O4">
            <title>IGE-1 200 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O5">
            <title>IGE-2 20 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O6">
            <title>IGE-2 60 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O7">
            <title>IGE-2 200 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O8">
            <title>Saline Placebo</title>
            <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination</title>
          <description>Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: &gt;2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [&gt;=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O4" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O8" value="1.6" lower_limit="0.2" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O4" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O8" value="1.6" lower_limit="0.2" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O5" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O6" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="4.8" lower_limit="1.8" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O5" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O6" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="4.8" lower_limit="1.8" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="47.6" lower_limit="32.1" upper_limit="63.6"/>
                    <measurement group_id="O3" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O4" value="55.0" lower_limit="38.5" upper_limit="70.7"/>
                    <measurement group_id="O5" value="45.0" lower_limit="29.3" upper_limit="61.5"/>
                    <measurement group_id="O6" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O7" value="40.0" lower_limit="24.9" upper_limit="56.7"/>
                    <measurement group_id="O8" value="42.9" lower_limit="34.4" upper_limit="51.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="28.6" lower_limit="15.8" upper_limit="44.8"/>
                    <measurement group_id="O3" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O4" value="50.0" lower_limit="33.8" upper_limit="66.2"/>
                    <measurement group_id="O5" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O6" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O7" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O8" value="28.6" lower_limit="21.1" upper_limit="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="19.0" lower_limit="8.6" upper_limit="34.5"/>
                    <measurement group_id="O3" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O4" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O5" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O6" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O7" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O8" value="14.3" lower_limit="8.8" upper_limit="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="81.0" lower_limit="65.5" upper_limit="91.4"/>
                    <measurement group_id="O3" value="55.0" lower_limit="38.5" upper_limit="70.7"/>
                    <measurement group_id="O4" value="70.0" lower_limit="53.3" upper_limit="83.4"/>
                    <measurement group_id="O5" value="75.0" lower_limit="58.5" upper_limit="87.3"/>
                    <measurement group_id="O6" value="60.0" lower_limit="43.3" upper_limit="75.1"/>
                    <measurement group_id="O7" value="55.0" lower_limit="38.5" upper_limit="70.7"/>
                    <measurement group_id="O8" value="65.1" lower_limit="56.3" upper_limit="73.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="47.6" lower_limit="32.1" upper_limit="63.6"/>
                    <measurement group_id="O3" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O4" value="40.0" lower_limit="24.9" upper_limit="56.7"/>
                    <measurement group_id="O5" value="50.0" lower_limit="33.8" upper_limit="66.2"/>
                    <measurement group_id="O6" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O7" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O8" value="39.7" lower_limit="31.3" upper_limit="48.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="33.3" lower_limit="19.6" upper_limit="49.7"/>
                    <measurement group_id="O3" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O4" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O5" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O6" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O7" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O8" value="23.8" lower_limit="16.9" upper_limit="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="1.6" lower_limit="0.2" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="20.1" upper_limit="79.9"/>
                    <measurement group_id="O2" value="61.9" lower_limit="45.6" upper_limit="76.4"/>
                    <measurement group_id="O3" value="85.0" lower_limit="69.6" upper_limit="94.4"/>
                    <measurement group_id="O4" value="85.0" lower_limit="69.6" upper_limit="94.4"/>
                    <measurement group_id="O5" value="70.0" lower_limit="53.3" upper_limit="83.4"/>
                    <measurement group_id="O6" value="60.0" lower_limit="43.3" upper_limit="75.1"/>
                    <measurement group_id="O7" value="65.0" lower_limit="48.2" upper_limit="79.3"/>
                    <measurement group_id="O8" value="66.7" lower_limit="57.9" upper_limit="74.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="19.0" lower_limit="8.6" upper_limit="34.5"/>
                    <measurement group_id="O3" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O4" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O5" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O6" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O7" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O8" value="23.8" lower_limit="16.9" upper_limit="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="9.3" upper_limit="66.7"/>
                    <measurement group_id="O2" value="42.9" lower_limit="27.8" upper_limit="59.0"/>
                    <measurement group_id="O3" value="55.0" lower_limit="38.5" upper_limit="70.7"/>
                    <measurement group_id="O4" value="45.0" lower_limit="29.3" upper_limit="61.5"/>
                    <measurement group_id="O5" value="40.0" lower_limit="24.9" upper_limit="56.7"/>
                    <measurement group_id="O6" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O7" value="40.0" lower_limit="24.9" upper_limit="56.7"/>
                    <measurement group_id="O8" value="42.9" lower_limit="34.4" upper_limit="51.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O4" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Muscle Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="33.3" upper_limit="90.7"/>
                    <measurement group_id="O2" value="71.4" lower_limit="55.2" upper_limit="84.2"/>
                    <measurement group_id="O3" value="75.0" lower_limit="58.5" upper_limit="87.3"/>
                    <measurement group_id="O4" value="75.0" lower_limit="58.5" upper_limit="87.3"/>
                    <measurement group_id="O5" value="70.0" lower_limit="53.3" upper_limit="83.4"/>
                    <measurement group_id="O6" value="50.0" lower_limit="33.8" upper_limit="66.2"/>
                    <measurement group_id="O7" value="60.0" lower_limit="43.3" upper_limit="75.1"/>
                    <measurement group_id="O8" value="34.9" lower_limit="26.9" upper_limit="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Muscle Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="9.3" upper_limit="66.7"/>
                    <measurement group_id="O2" value="52.4" lower_limit="36.4" upper_limit="67.9"/>
                    <measurement group_id="O3" value="45.0" lower_limit="29.3" upper_limit="61.5"/>
                    <measurement group_id="O4" value="40.0" lower_limit="24.9" upper_limit="56.7"/>
                    <measurement group_id="O5" value="45.0" lower_limit="29.3" upper_limit="61.5"/>
                    <measurement group_id="O6" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O7" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O8" value="15.9" lower_limit="10.1" upper_limit="23.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Muscle Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="19.0" lower_limit="8.6" upper_limit="34.5"/>
                    <measurement group_id="O3" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O4" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O5" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O6" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O7" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O8" value="19.0" lower_limit="12.8" upper_limit="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Muscle Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Joint Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="20.1" upper_limit="79.9"/>
                    <measurement group_id="O2" value="33.3" lower_limit="19.6" upper_limit="49.7"/>
                    <measurement group_id="O3" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O4" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O5" value="45.0" lower_limit="29.3" upper_limit="61.5"/>
                    <measurement group_id="O6" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O7" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O8" value="20.6" lower_limit="14.1" upper_limit="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild Joint Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="9.3" upper_limit="66.7"/>
                    <measurement group_id="O2" value="28.6" lower_limit="15.8" upper_limit="44.8"/>
                    <measurement group_id="O3" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O4" value="20.0" lower_limit="9.0" upper_limit="36.1"/>
                    <measurement group_id="O5" value="35.0" lower_limit="20.7" upper_limit="51.8"/>
                    <measurement group_id="O6" value="30.0" lower_limit="16.6" upper_limit="46.7"/>
                    <measurement group_id="O7" value="25.0" lower_limit="12.7" upper_limit="41.5"/>
                    <measurement group_id="O8" value="12.7" lower_limit="7.5" upper_limit="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate Joint Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="4.8" lower_limit="0.5" upper_limit="17.3"/>
                    <measurement group_id="O3" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O4" value="15.0" lower_limit="5.6" upper_limit="30.4"/>
                    <measurement group_id="O5" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O6" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O7" value="10.0" lower_limit="2.7" upper_limit="24.5"/>
                    <measurement group_id="O8" value="7.9" lower_limit="3.9" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe Joint Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O8" value="0.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="33.3" upper_limit="90.7"/>
                    <measurement group_id="O2" value="100.0" lower_limit="89.6" upper_limit="100.0"/>
                    <measurement group_id="O3" value="90.0" lower_limit="75.5" upper_limit="97.3"/>
                    <measurement group_id="O4" value="100.0" lower_limit="89.1" upper_limit="100.0"/>
                    <measurement group_id="O5" value="95.0" lower_limit="81.9" upper_limit="99.5"/>
                    <measurement group_id="O6" value="85.0" lower_limit="69.6" upper_limit="94.4"/>
                    <measurement group_id="O7" value="85.0" lower_limit="69.6" upper_limit="94.4"/>
                    <measurement group_id="O8" value="82.5" lower_limit="74.8" upper_limit="88.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Severe Systemic Reaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="1.7" upper_limit="51.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="10.4"/>
                    <measurement group_id="O3" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O4" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O5" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O6" value="0.0" lower_limit="0.0" upper_limit="10.9"/>
                    <measurement group_id="O7" value="5.0" lower_limit="0.5" upper_limit="18.1"/>
                    <measurement group_id="O8" value="1.6" lower_limit="0.2" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs</title>
        <description>An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.</description>
        <time_frame>Baseline up to 336 days post study administration or at Early Termination</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>IGE-1 6 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O2">
            <title>IGE-1 20 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O3">
            <title>IGE-1 60 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O4">
            <title>IGE-1 200 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O5">
            <title>IGE-2 20 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O6">
            <title>IGE-2 60 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O7">
            <title>IGE-2 200 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O8">
            <title>Saline Placebo</title>
            <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs</title>
          <description>An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="19"/>
                    <measurement group_id="O6" value="19"/>
                    <measurement group_id="O7" value="17"/>
                    <measurement group_id="O8" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with SAEs</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="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with severe TEAEs</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="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Permanent discontinuations due to TEAEs</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="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporary discontinuations due to TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with treatment-related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Laboratory Test Abnormalities</title>
        <description>Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.</description>
        <time_frame>Baseline up to 336 days post last study drug administration or Early Termination</time_frame>
        <population>All randomized participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>IGE-1 6 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O2">
            <title>IGE-1 20 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O3">
            <title>IGE-1 60 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O4">
            <title>IGE-1 200 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O5">
            <title>IGE-2 20 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O6">
            <title>IGE-2 60 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O7">
            <title>IGE-2 200 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O8">
            <title>Saline Placebo</title>
            <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Test Abnormalities</title>
          <description>Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.</description>
          <population>All randomized participants who received at least one dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="12"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336</title>
        <description>Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.</description>
        <time_frame>Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)</time_frame>
        <population>All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>IGE-1 6 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O2">
            <title>IGE-1 20 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O3">
            <title>IGE-1 60 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O4">
            <title>IGE-1 200 mcg</title>
            <description>Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O5">
            <title>IGE-2 20 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O6">
            <title>IGE-2 60 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O7">
            <title>IGE-2 200 mcg</title>
            <description>Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.</description>
          </group>
          <group group_id="O8">
            <title>Saline Placebo</title>
            <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</description>
          </group>
        </group_list>
        <measure>
          <title>Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336</title>
          <description>Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.</description>
          <population>All randomized participants who received at least 1 dose of randomized treatment, n=number of evaluable participants at the specified time point.</population>
          <units>units/milliliter (u/mL)</units>
          <param>Number</param>
          <dispersion>80% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="60"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1 (n=6,21,20,20,20,20,20,62)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                    <measurement group_id="O2" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                    <measurement group_id="O3" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                    <measurement group_id="O4" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                    <measurement group_id="O5" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                    <measurement group_id="O6" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                    <measurement group_id="O7" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                    <measurement group_id="O8" value="2002.8" lower_limit="2002.8" upper_limit="2002.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 182 (n=5,18,16,19,19,18,19,57)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11310.6" lower_limit="5642.0" upper_limit="22674.9"/>
                    <measurement group_id="O2" value="44480.1" lower_limit="30845.9" upper_limit="64141.0"/>
                    <measurement group_id="O3" value="72925.4" lower_limit="49484.3" upper_limit="107470.7"/>
                    <measurement group_id="O4" value="126981.7" lower_limit="88942.3" upper_limit="181290.0"/>
                    <measurement group_id="O5" value="35833.4" lower_limit="25031.3" upper_limit="51296.9"/>
                    <measurement group_id="O6" value="41947.5" lower_limit="29086.0" upper_limit="60496.1"/>
                    <measurement group_id="O7" value="106036.8" lower_limit="73954.8" upper_limit="152036.2"/>
                    <measurement group_id="O8" value="2147.9" lower_limit="1745.8" upper_limit="2642.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 336 (n=5,18,16,17,18,16,6,52)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1896.7" lower_limit="846.6" upper_limit="4248.9"/>
                    <measurement group_id="O2" value="17836.4" lower_limit="11665.8" upper_limit="27271.1"/>
                    <measurement group_id="O3" value="22611.2" lower_limit="14425.4" upper_limit="35442.0"/>
                    <measurement group_id="O4" value="42772.1" lower_limit="27643.3" upper_limit="66180.7"/>
                    <measurement group_id="O5" value="9642.9" lower_limit="6298.5" upper_limit="14763.1"/>
                    <measurement group_id="O6" value="12490.1" lower_limit="7966.5" upper_limit="19582.1"/>
                    <measurement group_id="O7" value="43979.2" lower_limit="20992.0" upper_limit="92138.2"/>
                    <measurement group_id="O8" value="2265.3" lower_limit="1761.5" upper_limit="2913.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 336 days post study administration or at Early Termination</time_frame>
      <desc>All treated participants were analyzed for AEs. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and a nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>IGE-1 6 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="E2">
          <title>IGE-1 20 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="E3">
          <title>IGE-1 60 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="E4">
          <title>IGE-1 200 mcg</title>
          <description>Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="E5">
          <title>IGE-2 20 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="E6">
          <title>IGE-2 60 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="E7">
          <title>IGE-2 200 mcg</title>
          <description>Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.</description>
        </group>
        <group group_id="E8">
          <title>Saline Placebo</title>
          <description>Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>18.1</default_vocab>
        <default_assessment>Non-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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="17" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="54" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Intestinal polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Local swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Blister infected</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Gastric infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Lyme disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Malaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tinea versicolour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="26" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <description>Gender-specific event.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vulvovaginitis</sub_title>
                <description>Gender-specific event.</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Intervertebral disc injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Post procedural oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Food intolerance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </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="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Chondrolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Muscle mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Muscle contractions involuntary</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Bruxism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Urethral discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Penile blister</sub_title>
                <description>Gender-specific disorder</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="58"/>
              </event>
              <event>
                <sub_title>Postmenopausal haemorrhage</sub_title>
                <description>Gender-specific disorder</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="63"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc</organization>
      <phone>18007181021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01723254
org study id: B4901001
secondary id: ANTI- IGE VACCINE
nct id: NCT01723254
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and tolerability of different doses of
      PF-06444753 and PF-06444752 in subjects with allergic rhinitis.
allocation: Randomized
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentages of Participants With Local Reactions By Severity Within 14 Days of Any Vaccination
time frame: Within 14 days
description: Local reactions consisted of any pain at the site of injection, any swelling, and any redness. Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any local reactions for 14 days following each vaccination. Grading details are as follows: Mild (Pain: did not interfere with activity; Redness and Swelling: 0.5-5.0 centimeters [cm] or 1-10 caliper units), Moderate (Pain: interfered with activity; Redness and Swelling: more than [>] 5.0 to 10.0 cm or 11-20 caliper units), Severe (Pain: prevented daily activity; Redness and Swelling: >10 cm or 21 caliper units and above).
measure: Percentages of Participants With Systemic Reactions By Severity Within 14 Days of Any Vaccination
time frame: Within 14 days
description: Systemic reactions consisted of fever, vomiting, diarrhea, headache, fatigue, muscle pain (other than at the injection site) and joint pain (other than pain adjacent to injection site). Participants were issued an electronic diary (e-diary) and were asked to monitor and record (according to corresponding grading scales) any systemic reactions for 14 days following each vaccination. Grading details are as follows: Mild (Vomiting: 1-2 times in 24 hours; Diarrhea: 2-3 loose stools in 24 hours; Headache, Fatigue, Muscle Pain, Joint Pain: no interference with activity), Moderate (Vomiting: >2 times in 24 hours; Diarrhea: 4-5 loose stools in 24 hours; Headache, Fatigue, Muscle and Joint Pain: some interference with activity), Severe (Vomiting: required intravenous hydration; Diarrhea: more than or equal to [>=] 6 stool in 24 hours; Headache, Fatigue, Muscle and Joint Pain: Significant, prevented daily activity).
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Discontinuations From Treatment Due to TEAEs
time frame: Baseline up to 336 days post study administration or at Early Termination
description: An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severe TEAEs were those that interfered significantly with the participant's usual function. Causality assessment was made by the investigator.
measure: Number of Participants With Laboratory Test Abnormalities
time frame: Baseline up to 336 days post last study drug administration or Early Termination
description: Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, hormones, clinical chemistry, immunology urinalysis, urinalysis (dipstick and microscopy), and other tests such as human immunodeficiency virus antibody and hepatitis C antibody.
measure: Enzyme-Linked Immunosorbent Assay (ELISA) Measured Anti-IgE Geometric Mean Titers (GMTs) at Baseline, Day 182, and Day 336
time frame: Baseline (Day 1), Day 182 (2 weeks after last vaccination), and end of study (Day 336)
description: Ability of vaccine induced serum anti-immunoglobulin E (IgE) antibodies to interfere with IgE binding to recombinant alpha chain of the high affinity IgE receptor was assessed in an ELISA based assay. GMTs were calculated both as crude means (unadjusted) and by an analysis of covariance (ANCOVA) model with natural log transformed antibody titer as outcome variable, and treatment group as factor and baseline (in log scale) as covariates at each of the post dose measurement.
arm group label: PF-06444753
arm group type: Experimental
arm group label: PF-06444752
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
description: Intramuscular
intervention type: Biological
intervention name: IGE-1
description: Intramuscular, multiple dose
arm group label: PF-06444753
intervention type: Biological
intervention name: IGE-2
description: Intramuscular, multiple dose
arm group label: PF-06444752
intervention type: Biological
intervention name: Saline
description: Saline (0.9% sodium chloride)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
country: Canada
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4901001&StudyName=A%20Study%20To%20Assess%20The%20Safety%20And%20Tolerability%20Of%20Different%20Doses%20Of%20PF-06444753%20And%20PF-06444752%20In%20Subjects%20With%20Allergic%20Rhinitis
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Immunoglobulin E
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 