<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/NCT02998671</url>
  </required_header>
  <id_info>
    <org_study_id>CCJM112X2203</org_study_id>
    <nct_id>NCT02998671</nct_id>
  </id_info>
  <brief_title>Study of Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne</brief_title>
  <official_title>A Randomized, Subject and Investigator Blinded, Placebo-controlled, Multi-center Study in Parallel Groups to Assess the Efficacy and Safety of CJM112 in Patients With Moderate to Severe Inflammatory Acne</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</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 study was designed primarily to assess preliminary efficacy and safety of CJM112 in&#xD;
      patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate&#xD;
      clinical profile for further clinical development. In addition, sustainability of response&#xD;
      and dose relationship were to be explored.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 1, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total Inflammatory Facial Lesion Count at Day 85</measure>
    <time_frame>Day 85</time_frame>
    <description>Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and Severity of Adverse Events in Period 1</measure>
    <time_frame>Day 1 to Day 85</time_frame>
    <description>Frequency and severity of adverse events in Period 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and Severity of Adverse Events in Period 2</measure>
    <time_frame>Day 86 to Day 260</time_frame>
    <description>Frequency and severity of adverse events in Period 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1</measure>
    <time_frame>Day 1, Day 29, Day 57 and Day 85</time_frame>
    <description>Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2</measure>
    <time_frame>Day 85, Day 113, Day 141 and Day 169</time_frame>
    <description>Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters</measure>
    <time_frame>38 Weeks</time_frame>
    <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters</measure>
    <time_frame>38 Weeks</time_frame>
    <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters</measure>
    <time_frame>38 Weeks</time_frame>
    <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Acne Vulgaris</condition>
  <arm_group>
    <arm_group_label>Group 1: CJM112 high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: CJM112 low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Placebo, CJM112 low dose or high dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CJM112</intervention_name>
    <arm_group_label>Group 1: CJM112 high dose</arm_group_label>
    <arm_group_label>Group 2: CJM112 low dose</arm_group_label>
    <arm_group_label>Group 3: Placebo, CJM112 low dose or high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Group 3: Placebo, CJM112 low dose or high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects aged 18 to 45 years of age included, and otherwise in good&#xD;
             health as determined by medical history, physical examination, vital signs, ECGs and&#xD;
             laboratory tests at screening.&#xD;
&#xD;
          -  Body weight between 50 and 120 kg, inclusive at screening.&#xD;
&#xD;
          -  Patients with papulo-pustular acne vulgaris with between 25 and 100 facial&#xD;
             inflammatory lesions (papules, pustules and nodules), and presence of non-inflammatory&#xD;
             lesions (open and closed comedones) in the face at screening and baseline, who have&#xD;
             failed systemic therapy for inflammatory acne.&#xD;
&#xD;
          -  No more than 5 facial inflammatory nodules at screening and baseline.&#xD;
&#xD;
          -  Investigator's Global assessment (IGA) score of at least moderate (3) acne severity on&#xD;
             the face at screening and baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Appropriate wash out periods are required for investigational drugs, any oral/systemic&#xD;
             treatment for acne, systemic or lesional injected (for acne) corticosteroids or&#xD;
             systemic immunomodulators, any systemic hormonal treatments, previous treatment with&#xD;
             biologics, oral retinoids (in particular isotretinoin) and any topical anti-acne&#xD;
             treatment.&#xD;
&#xD;
          -  Use of facial medium depth chemical peels (excluding home regimens) within 3 months&#xD;
             prior to baseline.&#xD;
&#xD;
          -  Any live vaccines (this includes nasal-spray flu vaccine) starting from 6 weeks before&#xD;
             baseline.&#xD;
&#xD;
          -  Any other forms of acne&#xD;
&#xD;
          -  Any severe, progressive or uncontrolled medical or psychiatric condition or other&#xD;
             factors at randomization that in the judgment of the investigator prevents the patient&#xD;
             from participating in the study.&#xD;
&#xD;
          -  History of hypersensitivity or allergy to the investigational compound/compound class&#xD;
             being used in this study.&#xD;
&#xD;
          -  Active systemic infections (other than common cold) during the 2 weeks prior to&#xD;
             baseline.&#xD;
&#xD;
          -  History of severe systemic Candida infections or evidence of Candidiasis in the 2&#xD;
             weeks prior to baseline.&#xD;
&#xD;
          -  Evidence of active tuberculosis at screening. All patients will be tested for&#xD;
             tuberculosis status using a blood test (QuantiFERON®-TB (Tuberculosis) Gold In-Tube).&#xD;
             Patients with evidence of tuberculosis may enter the trial afteradequate treatment has&#xD;
             been started according to local regulations.&#xD;
&#xD;
          -  Patients with known active Crohn's disease&#xD;
&#xD;
          -  History of immunodeficiency diseases, including a positive HIV (ELISA and Western&#xD;
             blot) test result at screening.&#xD;
&#xD;
          -  A positive Hepatitis B surface antigen or Hepatitis C test result at screening&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a&#xD;
             female after conception and until the termination of gestation, confirmed by a&#xD;
             positive Human chorionic gonadotropin (HCG) laboratory test.&#xD;
&#xD;
          -  WOCBP, defined as all women physiologically capable of becoming pregnant, unless they&#xD;
             are using highly effective methods of contraception during dosing and for 13 weeks&#xD;
             after stopping medication.&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Culver City</city>
        <state>California</state>
        <zip>90230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bonn</city>
        <zip>53111</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pommelsbrunn</city>
        <zip>91224</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bergen op Zoom</city>
        <zip>4624 VT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leiden</city>
        <zip>2333 CL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>July 31, 2019</results_first_submitted>
  <results_first_submitted_qc>October 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 10, 2019</results_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acne, inflammatory acne, efficacy, safety, PK</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </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>December 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT02998671/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>August 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT02998671/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of approximately 75 subjects were planned to be enrolled in the study. The study was terminated early due to futility after a total of 52 subjects were enrolled and randomized.</recruitment_details>
      <pre_assignment_details>For period 1 (12 weeks) subjects were randomized to one of the 3 treatment groups CJM112 high dose, CJM112 low dose or placebo.&#xD;
For Period 2 (12 weeks) subjects treated with Placebo in Period 1 were rerandomized to CJM112 high dose or CJM112 low dose. All other subjects remained on the same dose.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
          <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="P2">
          <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
          <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="P3">
          <title>P1: Placebo / P2: CJM112 High Dose</title>
          <description>Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="P4">
          <title>P1: Placebo / P2: CJM112 Low Dose</title>
          <description>Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="P5">
          <title>P1: Placebo / P2: NA</title>
          <description>Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated By Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
          <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="B2">
          <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
          <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="B3">
          <title>P1: Placebo / P2: CJM112 High Dose</title>
          <description>Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="B4">
          <title>P1: Placebo / P2: CJM112 Low Dose</title>
          <description>Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
        </group>
        <group group_id="B5">
          <title>P1: Placebo / P2: NA</title>
          <description>Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2</description>
        </group>
        <group group_id="B6">
          <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="21"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.8" spread="4.19"/>
                    <measurement group_id="B2" value="25.5" spread="5.99"/>
                    <measurement group_id="B3" value="22.5" spread="3.21"/>
                    <measurement group_id="B4" value="25" spread="4.66"/>
                    <measurement group_id="B5" value="23.75" spread="4.35"/>
                    <measurement group_id="B6" value="24.3" spread="4.62"/>
                  </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="13"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</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="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Inflammatory Facial Lesion Count at Day 85</title>
        <description>Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85</description>
        <time_frame>Day 85</time_frame>
        <population>Pharmacodynamic analysis set, including only patients completing 12-week assessments.</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O3">
            <title>P1: Placebo / P2 CJM112 Low Dose or High Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)</description>
          </group>
        </group_list>
        <measure>
          <title>Total Inflammatory Facial Lesion Count at Day 85</title>
          <description>Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85</description>
          <population>Pharmacodynamic analysis set, including only patients completing 12-week assessments.</population>
          <units>Lesions</units>
          <param>Geometric Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" lower_limit="16.58" upper_limit="29.14"/>
                    <measurement group_id="O2" value="20.3" lower_limit="13.76" upper_limit="29.66"/>
                    <measurement group_id="O3" value="18.5" lower_limit="13.51" upper_limit="25.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Comparison at end of Period 1 (P1): CJM112 versus Placebo.</non_inferiority_desc>
            <param_type>Ratio of geometric means</param_type>
            <param_value>1.18</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.81</ci_upper_limit>
            <estimate_desc>Ratio of Geometric Means (CJM112 / Placebo) calculated. A value &gt; 1 indicates a higher number of lesion counts in the CJM112 group.&#xD;
Bayesian analysis. The &quot;credible interval&quot; was calculated and presented under &quot;confidence interval&quot;.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Comparison at end of Period 1 (P1): CJM112 versus Placebo.</non_inferiority_desc>
            <param_type>Ratio of geometric means</param_type>
            <param_value>1.10</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
            <estimate_desc>Ratio of Geometric Means (CJM112 / Placebo) calculated. A value &gt; 1 indicates a higher number of lesion counts in the CJM112 group.&#xD;
Bayesian analysis. The &quot;credible interval&quot; was calculated and presented under &quot;confidence interval&quot;.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Severity of Adverse Events in Period 1</title>
        <description>Frequency and severity of adverse events in Period 1</description>
        <time_frame>Day 1 to Day 85</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O3">
            <title>P1: Placebo / P2 CJM112 Low Dose or High Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose or CJM112 high dose in extension period 2 (Day 86 - 169)</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Severity of Adverse Events in Period 1</title>
          <description>Frequency and severity of adverse events in Period 1</description>
          <population>Safety analysis set</population>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of AEs of mild intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of AEs of moderate intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of AEs of severe intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number and Severity of Adverse Events in Period 2</title>
        <description>Frequency and severity of adverse events in Period 2</description>
        <time_frame>Day 86 to Day 260</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O3">
            <title>P1: Placebo / P2: CJM112 High Dose</title>
            <description>Placebo in treatment period 1; CJM112 high dose in extension period 2</description>
          </group>
          <group group_id="O4">
            <title>P1: Placebo / P2: CJM112 Low Dose</title>
            <description>Placebo in treatment period 1; CJM112 low dose in extension period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number and Severity of Adverse Events in Period 2</title>
          <description>Frequency and severity of adverse events in Period 2</description>
          <population>Safety analysis set</population>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of AEs of mild intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of AEs of moderate intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of AEs of severe intensity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1</title>
        <description>Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.</description>
        <time_frame>Day 1, Day 29, Day 57 and Day 85</time_frame>
        <population>Pharmacokinetic analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1</title>
          <description>Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.</description>
          <population>Pharmacokinetic analysis set</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Period 1 Day 1 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152" spread="663"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 1 Day 29 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8670" spread="3370"/>
                    <measurement group_id="O2" value="802" spread="961"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 1 Day 57 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11500" spread="5020"/>
                    <measurement group_id="O2" value="1550" spread="1130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 1 Day 85 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17000" spread="8080"/>
                    <measurement group_id="O2" value="2040" spread="1570"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2</title>
        <description>Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.</description>
        <time_frame>Day 85, Day 113, Day 141 and Day 169</time_frame>
        <population>Pharmacokinetic analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O3">
            <title>P1: Placebo / P2: CJM112 High Dose</title>
            <description>Placebo in treatment period 1; CJM112 high dose in extension period 2</description>
          </group>
          <group group_id="O4">
            <title>P1: Placebo / P2: CJM112 Low Dose</title>
            <description>Placebo in treatment period 1; CJM112 low dose in extension period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2</title>
          <description>Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.</description>
          <population>Pharmacokinetic analysis set</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Period 2 Day 85 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17000" spread="8080"/>
                    <measurement group_id="O2" value="2040" spread="1570"/>
                    <measurement group_id="O3" value="713" spread="1750"/>
                    <measurement group_id="O4" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 2 Day 113 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15900" spread="8140"/>
                    <measurement group_id="O2" value="1890" spread="634"/>
                    <measurement group_id="O3" value="8260" spread="5120"/>
                    <measurement group_id="O4" value="1430" spread="1190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 2 Day 141 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18700" spread="9450"/>
                    <measurement group_id="O2" value="3140" spread="2180"/>
                    <measurement group_id="O3" value="15700" spread="10700"/>
                    <measurement group_id="O4" value="3700" spread="1250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 2 Day 169 (Pre Dose)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19400" spread="9650"/>
                    <measurement group_id="O2" value="3890" spread="1890"/>
                    <measurement group_id="O3" value="16600" spread="6610"/>
                    <measurement group_id="O4" value="2890" spread="672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters</title>
        <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
        <time_frame>38 Weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O3">
            <title>P1: Placebo / P2: CJM112 High Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O4">
            <title>P1: Placebo / P2: CJM112 Low Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O5">
            <title>P1: Placebo / P2: NA</title>
            <description>Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters</title>
          <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
          <population>Safety Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters</title>
        <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
        <time_frame>38 Weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O3">
            <title>P1: Placebo / P2: CJM112 High Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O4">
            <title>P1: Placebo / P2: CJM112 Low Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O5">
            <title>P1: Placebo / P2: NA</title>
            <description>Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters</title>
          <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
          <population>Safety Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters</title>
        <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
        <time_frame>38 Weeks</time_frame>
        <population>Safety Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>P1: CJM112 High Dose / P2: CJM112 High Dose</title>
            <description>CJM112 high dose (300mg) in treatment period 1 (Day 1 - 85) ; CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O2">
            <title>P1: CJM112 Low Dose / P2: CJM112 Low Dose</title>
            <description>CJM112 low dose (75mg) in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O3">
            <title>P1: Placebo / P2: CJM112 High Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85); CJM112 high dose (300mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O4">
            <title>P1: Placebo / P2: CJM112 Low Dose</title>
            <description>Placebo in treatment period 1 (Day 1 - 85) ; CJM112 low dose (75mg) in extension period 2 (Day 86 - 169)</description>
          </group>
          <group group_id="O5">
            <title>P1: Placebo / P2: NA</title>
            <description>Placebo in treatment period 1 (Day 1 - 85); Patients did not enter extension period 2</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters</title>
          <description>Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.</description>
          <population>Safety Analysis Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>38 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Period 1: CJM112 High Dose</title>
          <description>Period 1: CJM112 high dose (300mg)</description>
        </group>
        <group group_id="E2">
          <title>Period 1: CJM112 Low Dose</title>
          <description>Period 1: CJM112 low dose (75mg)</description>
        </group>
        <group group_id="E3">
          <title>Period 1: Placebo</title>
          <description>Period 1: Placebo</description>
        </group>
        <group group_id="E4">
          <title>Period 1: Pooled CJM112</title>
          <description>Period 1: Pooled CJM112</description>
        </group>
        <group group_id="E5">
          <title>Period 2: CJM112 High Dose/CJM112 High Dose</title>
          <description>CJM112 high dose (300mg) in treatment period 1; CJM112 high dose (300mg) in extension period 2</description>
        </group>
        <group group_id="E6">
          <title>Period 2: CJM112 Low Dose/CJM112 Low Dose</title>
          <description>CJM112 low dose (75mg) in treatment period 1 ; CJM112 low dose (75mg) in extension period 2</description>
        </group>
        <group group_id="E7">
          <title>Period 2: Placebo/ CJM112 High Dose</title>
          <description>Placebo in treatment period 1; CJM112 high dose (300mg) in extension period 2</description>
        </group>
        <group group_id="E8">
          <title>Period 2: Placebo/ CJM112 Low Dose</title>
          <description>Placebo in treatment period 1; CJM112 low dose (75mg) in extension period 2</description>
        </group>
        <group group_id="E9">
          <title>Period 2: Pooled CJM112 High Dose</title>
          <description>Period 2: Pooled CJM112 high dose (300mg)</description>
        </group>
        <group group_id="E10">
          <title>Period 2: Pooled CJM112 Low Dose</title>
          <description>Period 2: Pooled CJM112 low dose (75mg)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="15" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="14" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Helicobacter gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Sports injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Glucose urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Diffuse alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Pityriasis rosea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
      <email>novartis.email@novartis.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/NCT02998671
org study id: CCJM112X2203
nct id: NCT02998671
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study was designed primarily to assess preliminary efficacy and safety of CJM112 in
      patients with moderate to severe inflammatory acne and to determine if CJM112 has an adequate
      clinical profile for further clinical development. In addition, sustainability of response
      and dose relationship were to be explored.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Total Inflammatory Facial Lesion Count at Day 85
time frame: Day 85
description: Total inflammatory facial lesion count was the total count of papules, pustules and nodules assessed at day 85
measure: Number and Severity of Adverse Events in Period 1
time frame: Day 1 to Day 85
description: Frequency and severity of adverse events in Period 1
measure: Number and Severity of Adverse Events in Period 2
time frame: Day 86 to Day 260
description: Frequency and severity of adverse events in Period 2
measure: Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 1
time frame: Day 1, Day 29, Day 57 and Day 85
description: Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
measure: Pharmacokinetics (PK): Serum Trough Concentrations of CJM112 in Period 2
time frame: Day 85, Day 113, Day 141 and Day 169
description: Pharmacokinetics (PK): Serum trough concentrations of CJM112. Concentrations below the lower limit of quantification were reported as 0.
measure: Number of Patients With Clinically Significant Abnormal Hematology Laboratory Parameters
time frame: 38 Weeks
description: Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
measure: Number of Patients With Clinically Significant Abnormal Clinical Chemistry Laboratory Parameters Parameters
time frame: 38 Weeks
description: Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
measure: Number of Patients With Clinically Significant Abnormal Urinalysis Laboratory Parameters
time frame: 38 Weeks
description: Abnormalities were considered clinically significant by the Investigator if they could impact the study conduct or safety of the subjects.
arm group label: Group 1: CJM112 high dose
arm group type: Experimental
description: CJM112 high dose in treatment period 1; CJM112 high dose in extension period 2
arm group label: Group 2: CJM112 low dose
arm group type: Experimental
description: CJM112 low dose in treatment period 1; CJM112 low dose in extension period 2
arm group label: Group 3: Placebo, CJM112 low dose or high dose
arm group type: Placebo Comparator
description: Placebo in treatment period 1; CJM112 low dose or CJM112 high dose in extension period 2
intervention type: Biological
intervention name: CJM112
arm group label: Group 1: CJM112 high dose
arm group label: Group 2: CJM112 low dose
arm group label: Group 3: Placebo, CJM112 low dose or high dose
intervention type: Other
intervention name: Placebo
arm group label: Group 3: Placebo, CJM112 low dose or high dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
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country: Germany
country: Netherlands
country: United States
responsible party type: Sponsor
mesh term: Acne Vulgaris
sharing ipd: Undecided
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 