<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/NCT02993107</url>
  </required_header>
  <id_info>
    <org_study_id>ARC004</org_study_id>
    <nct_id>NCT02993107</nct_id>
  </id_info>
  <brief_title>PALISADE Follow-on Study (ARC004)</brief_title>
  <official_title>Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) Follow-on Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aimmune Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aimmune Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101&#xD;
      through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed&#xD;
      the ARC003 study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an international, multicenter, open-label, 2-arm follow-on study of the safety,&#xD;
      tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the&#xD;
      ARC003 study. This study will explore alternative dosing regimens during extended maintenance&#xD;
      with AR101.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)</measure>
    <time_frame>Up to 126 weeks</time_frame>
    <description>Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)</measure>
    <time_frame>Up to 126 weeks</time_frame>
    <description>The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">388</enrollment>
  <condition>Peanut Allergy</condition>
  <arm_group>
    <arm_group_label>Group 1 (Placebo Crossovers)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (Active Rollovers)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AR101</intervention_name>
    <description>AR101 powder provided in capsules &amp; sachets</description>
    <arm_group_label>Group 1 (Placebo Crossovers)</arm_group_label>
    <arm_group_label>Group 2 (Active Rollovers)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Completion of the ARC003 study&#xD;
&#xD;
          -  Written informed consent and/or assent from subjects/guardians as appropriate&#xD;
&#xD;
          -  Use of effective birth control by sexually active female subjects of child-bearing&#xD;
             potential&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Early discontinuation from the ARC003 study&#xD;
&#xD;
          -  Meets any longitudinally applicable ARC003 study exclusion criteria&#xD;
&#xD;
          -  (Group 2 only) Failure to tolerate ≥ 443 mg cumulative of peanut protein with no or&#xD;
             mild symptoms in the ARC003 study Exit DBPCFC&#xD;
&#xD;
          -  Any other condition that, in the opinion of the Investigator, precludes participation&#xD;
             for reasons of safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Director of Regulatory Affairs</last_name>
    <role>Study Director</role>
    <affiliation>Aimmune Regulatory Affairs</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner University of Arizona Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Associates of Southern California</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sean N. Parker Center for Allergy Research at Stanford University Packard-El Camino Hospital</name>
      <address>
        <city>Mountain View</city>
        <state>California</state>
        <zip>94040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Research Associates, Inc.</name>
      <address>
        <city>Rolling Hills Estates</city>
        <state>California</state>
        <zip>90274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Medical Group and Research Center, APC</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital, San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center, Santa Monica</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Allergy &amp; Asthma Centers, P.C.</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Clinical Research</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida Asthma, Allergy, and Immunology Clinical Research Unit</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Allergy &amp; Asthma Clinic, PA</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Allergy and Research, dba Idaho Research</name>
      <address>
        <city>Eagle</city>
        <state>Idaho</state>
        <zip>83616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comer Children's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sneeze, Wheeze, &amp; Itch Associates, LLC</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU North Riley Children's Specialist</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Clinical Research, Inc.</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital, Div. of Allergy &amp; Immunology</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Medicine, Michigan Clinical Research Unit</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute, Inc.</name>
      <address>
        <city>Plymouth</city>
        <state>Minnesota</state>
        <zip>55441</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy on Broadway</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Medical Research Institute Inc.</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Research Center, LLC</name>
      <address>
        <city>Ocean City</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai, Clinical Research Unit</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill, Clinical &amp; Translational Research Center (CTRC)</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baker Allergy, Asthma &amp; Dermatology</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97223</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Allergy and Asthma Research, LLC</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Bonheur Children's Hospital - Outpatient Building</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>'Specially for Children Allergy, Asthma and Immunology Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Health</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Sky Medical Research</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital, Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Texas Health Research</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvana Research Associates</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benaroya Research Inst. at Virginia Mason; Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asthma Inc Clinical Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triple A Lab</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S 1G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheema Research Inc.</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5A 3V4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottawa Allergy Research Corp</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1G 6C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gordon Sussman Clinical Research, Inc.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4V 1R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Children's Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Universitaetsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University Hospital</name>
      <address>
        <city>Cork</city>
        <zip>T12 DC4A</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beatrix Children's Hospital, University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700 RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Infantil Universitario Niño Jesús</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sachsska Children and Youth Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>118 83</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy &amp; St Thomas' NHS foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals, NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals, NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>September 28, 2021</results_first_submitted>
  <results_first_submitted_qc>November 18, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 15, 2021</results_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>AR101</keyword>
  <keyword>Characterized Peanut Allergen</keyword>
  <keyword>CPNA (Characterized Peanut Allergen)</keyword>
  <keyword>OIT (oral immunotherapy)</keyword>
  <keyword>Peanut Allergy</keyword>
  <keyword>Allergy</keyword>
  <keyword>Peanut-Allergic Children</keyword>
  <keyword>Peanut-Allergic Adults</keyword>
  <keyword>Desensitization</keyword>
  <keyword>PALISADE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Peanut Hypersensitivity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02993107/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT02993107/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group 1 (Placebo Crossovers)</title>
          <description>Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).</description>
        </group>
        <group group_id="P2">
          <title>Group 2: Cohort 1 (Active Rollovers)</title>
          <description>Received 300 mg/day (once daily, QD) peanut protein for 28 weeks</description>
        </group>
        <group group_id="P3">
          <title>Group 2: Cohort 2 (Active Rollovers)</title>
          <description>Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks</description>
        </group>
        <group group_id="P4">
          <title>Group 2: Cohort 3A (Active Rollovers)</title>
          <description>Received 300 mg/day peanut protein for 56 weeks</description>
        </group>
        <group group_id="P5">
          <title>Group 2: Cohort 3B (Active Rollovers)</title>
          <description>Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)</description>
        </group>
        <group group_id="P6">
          <title>Group 2: Cohort 3C (Active Rollovers)</title>
          <description>Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
                <participants group_id="P2" count="120"/>
                <participants group_id="P3" count="50"/>
                <participants group_id="P4" count="35"/>
                <participants group_id="P5" count="34"/>
                <participants group_id="P6" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Protocol Deviation</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="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Other Reasons</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="107"/>
                <participants group_id="P3" count="39"/>
                <participants group_id="P4" count="29"/>
                <participants group_id="P5" count="22"/>
                <participants group_id="P6" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 388 subjects were enrolled. However, only 381 received any amount of treatment and were included in the Safety population, which includes all subjects who received at least one dose of open-label study treatment in any cohort.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1 (Placebo Crossovers)</title>
          <description>Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks)</description>
        </group>
        <group group_id="B2">
          <title>Group 2: Cohort 1 (Active Rollovers)</title>
          <description>Received 300 mg/day (once daily, QD) peanut protein for 28 weeks</description>
        </group>
        <group group_id="B3">
          <title>Group 2: Cohort 2 (Active Rollovers)</title>
          <description>Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks</description>
        </group>
        <group group_id="B4">
          <title>Group 2: Cohort 3A (Active Rollovers)</title>
          <description>Received 300 mg/day peanut protein for 56 weeks</description>
        </group>
        <group group_id="B5">
          <title>Group 2: Cohort 3B (Active Rollovers)</title>
          <description>Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)</description>
        </group>
        <group group_id="B6">
          <title>Group 2: Cohort 3C (Active Rollovers)</title>
          <description>Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks)</description>
        </group>
        <group group_id="B7">
          <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="111"/>
            <count group_id="B2" value="117"/>
            <count group_id="B3" value="48"/>
            <count group_id="B4" value="35"/>
            <count group_id="B5" value="34"/>
            <count group_id="B6" value="36"/>
            <count group_id="B7" value="381"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age 18-55 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age 4-17 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="46"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="31"/>
                    <measurement group_id="B6" value="34"/>
                    <measurement group_id="B7" value="351"/>
                  </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="39"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="31"/>
                    <measurement group_id="B5" value="33"/>
                    <measurement group_id="B6" value="35"/>
                    <measurement group_id="B7" value="350"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="28"/>
                    <measurement group_id="B7" value="297"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)</title>
        <description>Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).</description>
        <time_frame>Up to 126 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (Overall)</title>
            <description>Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Cohort 1 (QD)</title>
            <description>Received 300 mg/day (once daily, QD) peanut protein for 28 weeks</description>
          </group>
          <group group_id="O3">
            <title>Group 2: Cohort 2 (Overall)</title>
            <description>Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks</description>
          </group>
          <group group_id="O4">
            <title>Group 2: Cohort 3A (QD)</title>
            <description>Received 300 mg/day peanut protein for 56 weeks</description>
          </group>
          <group group_id="O5">
            <title>Group 2: Cohort 3B (Overall)</title>
            <description>Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)</description>
          </group>
          <group group_id="O6">
            <title>Group 2: Cohort 3C (Overall)</title>
            <description>Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)</title>
          <description>Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="109"/>
                <count group_id="O3" value="46"/>
                <count group_id="O4" value="31"/>
                <count group_id="O5" value="31"/>
                <count group_id="O6" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="36"/>
                    <measurement group_id="O4" value="27"/>
                    <measurement group_id="O5" value="28"/>
                    <measurement group_id="O6" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 1: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="22"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 2: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4: Life-Threatening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 5: Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)</title>
        <description>The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).</description>
        <time_frame>Up to 126 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group 1 (Placebo Crossovers)</title>
            <description>Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks) (age 4-17).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Cohort 1 (Active Rollovers)</title>
            <description>Received 300 mg/day (once daily, QD) peanut protein for 28 weeks</description>
          </group>
          <group group_id="O3">
            <title>Group 2: Cohort 2 (Active Rollovers)</title>
            <description>Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks</description>
          </group>
          <group group_id="O4">
            <title>Group 2: Cohort 3A (Active Rollovers)</title>
            <description>Received 300 mg/day peanut protein for 56 weeks</description>
          </group>
          <group group_id="O5">
            <title>Group 2: Cohort 3B (Active Rollovers)</title>
            <description>Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks)</description>
          </group>
          <group group_id="O6">
            <title>Group 2: Cohort 3C (Active Rollovers)</title>
            <description>Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weeks, then once weekly (QW) for 28 weeks (total of 84 weeks)</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)</title>
          <description>The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).</description>
          <units>Percent of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="26"/>
                <count group_id="O5" value="22"/>
                <count group_id="O6" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage (and 95% CI) tolerating 300 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="92.5" upper_limit="100"/>
                    <measurement group_id="O2" value="98.1" lower_limit="93.2" upper_limit="99.8"/>
                    <measurement group_id="O3" value="94.7" lower_limit="82.3" upper_limit="99.4"/>
                    <measurement group_id="O4" value="100.0" lower_limit="86.8" upper_limit="100.0"/>
                    <measurement group_id="O5" value="81.8" lower_limit="59.7" upper_limit="94.8"/>
                    <measurement group_id="O6" value="90.5" lower_limit="69.6" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage (and 95% CI) tolerating 600 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.1" lower_limit="75.9" upper_limit="93.1"/>
                    <measurement group_id="O2" value="89.3" lower_limit="81.7" upper_limit="94.5"/>
                    <measurement group_id="O3" value="71.1" lower_limit="54.1" upper_limit="84.6"/>
                    <measurement group_id="O4" value="96.2" lower_limit="80.4" upper_limit="99.9"/>
                    <measurement group_id="O5" value="77.3" lower_limit="54.6" upper_limit="92.2"/>
                    <measurement group_id="O6" value="76.2" lower_limit="52.8" upper_limit="91.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage (and 95% CI) tolerating 1000 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2" lower_limit="60.4" upper_limit="82.1"/>
                    <measurement group_id="O2" value="80.6" lower_limit="71.6" upper_limit="87.7"/>
                    <measurement group_id="O3" value="57.9" lower_limit="40.8" upper_limit="73.7"/>
                    <measurement group_id="O4" value="96.2" lower_limit="80.4" upper_limit="99.99"/>
                    <measurement group_id="O5" value="68.2" lower_limit="45.1" upper_limit="86.1"/>
                    <measurement group_id="O6" value="66.7" lower_limit="43.0" upper_limit="85.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage (and 95% CI) tolerating 2000 mg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4" lower_limit="39.3" upper_limit="63.3"/>
                    <measurement group_id="O2" value="48.5" lower_limit="38.6" upper_limit="58.6"/>
                    <measurement group_id="O3" value="36.8" lower_limit="21.8" upper_limit="54.0"/>
                    <measurement group_id="O4" value="80.8" lower_limit="60.6" upper_limit="93.4"/>
                    <measurement group_id="O5" value="45.5" lower_limit="24.4" upper_limit="67.8"/>
                    <measurement group_id="O6" value="42.9" lower_limit="21.8" upper_limit="66.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>28 months</time_frame>
      <desc>The data is presented separately for the 4-17 year old age group (children and adolescents) and 18-55 year old age group (adults).</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1 (Age 4-17 Overall)</title>
          <description>Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).</description>
        </group>
        <group group_id="E2">
          <title>Group 2: Cohort 1 (Age 4-17 QD)</title>
          <description>Received 300 mg/day (once daily, QD) peanut protein for 28 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Group 2: Cohort 2 (Age 4-17 Overall)</title>
          <description>Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Group 2: Cohort 3A (Age 4-17 QD)</title>
          <description>Received 300 mg/day peanut protein for 56 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Group 2: Cohort 3B (Age 4-17 Overall)</title>
          <description>Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks).</description>
        </group>
        <group group_id="E6">
          <title>Group 2: Cohort 3C (Age 4-17 Overall)</title>
          <description>Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks).</description>
        </group>
        <group group_id="E7">
          <title>Group 1 (Age 18-55 Overall)</title>
          <description>Received AR101 during IDE (day 1, 0.5 to 3 or 6 mg; day 2, 3 mg), up-dosing (3-300 mg/day for 22-40 weeks, with dose escalations every 2 weeks), and maintenance (300 mg/day for 24-28 weeks).</description>
        </group>
        <group group_id="E8">
          <title>Group 2: Cohort 1 (Age 18-55 QD)</title>
          <description>Received 300 mg/day (once daily, QD) peanut protein for 28 weeks.</description>
        </group>
        <group group_id="E9">
          <title>Group 2: Cohort 2 (Age 18-55 Overall)</title>
          <description>Received 300 mg peanut protein every other day (QOD) for 4 weeks, then twice weekly (BIW) for 24 weeks for a total of 28 weeks.</description>
        </group>
        <group group_id="E10">
          <title>Group 2: Cohort 3A (Age 18-55 QD)</title>
          <description>Received 300 mg/day peanut protein for 56 weeks.</description>
        </group>
        <group group_id="E11">
          <title>Group 2: Cohort 3B (Age 18-55 Overall)</title>
          <description>Cohort 3B: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, then BIW for 24 weeks (total of 56 weeks).</description>
        </group>
        <group group_id="E12">
          <title>Group 2: Cohort 3C (Age 18-55 Overall)</title>
          <description>Cohort 3C: Received 300 mg/day peanut protein for 28 weeks, QOD for 4 weeks, BIW for 24 weekly (QW) for 28 weeks (total 84 weeks).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="98" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="90" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="28" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="33" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Thalassaemia beta</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </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="3" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eosinophilic oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Glossitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lip pruritus</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Swollen tongue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tongue pruritus</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Enterobiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pulmonary physical examination abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Eating disorder symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </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="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Choking</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nasal oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nasal turbinate hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pharyngeal paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sinus pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Throat tightness</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Rhinoplasty</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sclerotherapy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="46"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="2"/>
              </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>Institutions cannot publish until the multi-center sponsor publication is published&#xD;
Or, institutions cannot publish until 18 months after study completion&#xD;
And Sponsor review of any publications is required prior to any institution publications according to contractual agreements</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Regulatory Affairs</name_or_title>
      <organization>Aimmune Therapeutics, Inc.</organization>
      <phone>650-409-5164</phone>
      <email>RegulatoryAffairs@aimmune.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/NCT02993107
org study id: ARC004
nct id: NCT02993107
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to demonstrate the safety, tolerability, and efficacy of AR101
      through oral immunotherapy (OIT) in peanut-allergic children and adults who have completed
      the ARC003 study.
This is an international, multicenter, open-label, 2-arm follow-on study of the safety,
      tolerability, and efficacy of AR101 in peanut-allergic individuals who have completed the
      ARC003 study. This study will explore alternative dosing regimens during extended maintenance
      with AR101.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects Ages 4-17 With Treatment-related Adverse Events (TEAE)
time frame: Up to 126 weeks
description: Percentage of subjects ages 4-17 with at-least 1 TEAE, including serious adverse events, during the overall study period. The percentage of subjects reporting at least 1 TEAE by maximum reported severity is also presented using the 5-point CTCAE severity grading scale. All safety evaluations were conducted using the safety population (all subjects who received at least 1 dose of AR101 during ARC004), age 4-17 years. Safety data are presented for group 1 (former placebo) and Group 2 data are divided into columns for cohort 1 (QD), cohort 2 (overall), cohort 3A (QD), and cohorts 3B and 3C (overall).
measure: Percentage of Subjects Ages 4-17 Responding to Each Challenge Dose at Exit DBPCFC (Double-blind, Placebo-controlled Food Challenge)
time frame: Up to 126 weeks
description: The percentage of subjects who tolerated each the of 300 mg, 600 mg, 1000 mg, or 2000 mg challenge doses with no more than mild symptoms at exit DBPCFC. Analyses based on DBPCFCs used the completer population (age 4-17 years).
arm group label: Group 1 (Placebo Crossovers)
arm group type: Other
description: Subjects who complete the placebo arm of ARC003 and consent to enroll in ARC004 (Group-1) will cross over to active treatment with AR101 using the same dosing regimen used in ARC003 in open-label fashion. Group 1 subjects may also be assigned to cohorts which test the gradual lengthening of dosing intervals. Following the completion of their longest tested dosing interval, Group 1 subjects will undergo an exit double-blinded placebo-controlled food challenge (DBPCFC).
arm group label: Group 2 (Active Rollovers)
arm group type: Other
description: Subjects who successfully complete the active arm of ARC003 and consent to enroll in ARC004 (Group-2) will consecutively enter treatment with AR101 in one of three cohorts which will test alternate dosing intervals. There will be a DBPCFC at the completion of the subject's longest tested dosing interval.
intervention type: Biological
intervention name: AR101
description: AR101 powder provided in capsules & sachets
arm group label: Group 1 (Placebo Crossovers)
arm group label: Group 2 (Active Rollovers)
criteria: 
gender: All
minimum age: 4 Years
maximum age: 55 Years
healthy volunteers: No
last name: Director of Regulatory Affairs
role: Study Director
affiliation: Aimmune Regulatory Affairs
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country: Canada
country: Germany
country: Ireland
country: Italy
country: Netherlands
country: Spain
country: Sweden
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Hypersensitivity
mesh term: Peanut Hypersensitivity
sharing ipd: No
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