<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/NCT01693692</url>
  </required_header>
  <id_info>
    <org_study_id>0092</org_study_id>
    <nct_id>NCT01693692</nct_id>
  </id_info>
  <brief_title>Phase 2 Study of TD-9855 to Treat Fibromyalgia</brief_title>
  <official_title>A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theravance Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theravance Biopharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study study is to determine whether TD-9855 is effective in treating&#xD;
      patients with fibromyalgia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries</measure>
    <time_frame>Baseline and Week 6</time_frame>
    <description>Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibromyalgia Impact Questionnaire (FIQ)</measure>
    <time_frame>Day 43 (End of study treatment)</time_frame>
    <description>FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>Day 43 (End of study treatment)</time_frame>
    <description>PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">392</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>TD-9855 Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 to be dosed with TD-9855</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TD-9855 Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 to be dosed with TD-9855</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group to be dosed with Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-9855 Group 1</intervention_name>
    <arm_group_label>TD-9855 Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TD-9855 Group 2</intervention_name>
    <arm_group_label>TD-9855 Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)&#xD;
&#xD;
               -  Informed consent&#xD;
&#xD;
               -  18 to 65 years of age&#xD;
&#xD;
               -  Discontinue therapy with adrenergic-acting drugs, and certain other medications&#xD;
&#xD;
                    -  Only acetaminophen or NSAID as rescue pain medication&#xD;
&#xD;
                    -  No narcotic pain meds or benzodiazepines&#xD;
&#xD;
                    -  Only non-benzodiazepines as rescue hypnotics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II&#xD;
             disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric&#xD;
             Interview (MINI)&#xD;
&#xD;
          -  Major depression at screening by MINI when unable to be washed out of MDD meds&#xD;
             (investigator or provider's judgment)&#xD;
&#xD;
          -  Risk of suicide (investigator opinion and/or C-SSRS)&#xD;
&#xD;
          -  Recent history of substance or alcohol abuse&#xD;
&#xD;
          -  BMI &lt;18 or ≥45&#xD;
&#xD;
          -  Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history&#xD;
             of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or&#xD;
             orthostatic tachycardia; untreated sleep apnea&#xD;
&#xD;
          -  Abnormal lab values (liver, kidney, thyroid, and others)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Theravance Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rheumatology Associates of North Alabama, PC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dedicated Clinical Research</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85395</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriWest Research Associates, LLC</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arroyo Medical Group, Inc.</name>
      <address>
        <city>Pismo Beach</city>
        <state>California</state>
        <zip>93449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research, Inc.</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Connecticut Research, LLC</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Clinical Research Center, LLC</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PAB Clinical Research</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renstar Medical Research</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigation Specialists, Inc.</name>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSphere Medical Research Center, LLC</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GTC Research</name>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Clinical Research</name>
      <address>
        <city>Brockton</city>
        <state>Massachusetts</state>
        <zip>02301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beacon Clinical Research</name>
      <address>
        <city>New Bedford</city>
        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Pharmaceutical Research</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Biomedical Research of America</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Clinical Research Associates, LLC</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lillestol Research, LLC</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Source, Inc.</name>
      <address>
        <city>Perrysburg</city>
        <state>Ohio</state>
        <zip>43551</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulsa Clinical Research, LLC</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunstone Medical Research, LLC</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Center for Rheumatology &amp; Arthritis Care</name>
      <address>
        <city>Rock Hill</city>
        <state>South Carolina</state>
        <zip>29732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinSearch, LLC</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37421</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Rheumatology Research</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <results_first_submitted>February 9, 2022</results_first_submitted>
  <results_first_submitted_qc>February 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 4, 2022</results_first_posted>
  <disposition_first_submitted>September 10, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>September 10, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 13, 2018</disposition_first_posted>
  <last_update_submitted>February 9, 2022</last_update_submitted>
  <last_update_submitted_qc>February 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fibromyalgia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>392 participants were enrolled across 53 study sites in the United States.</recruitment_details>
      <pre_assignment_details>392 participants were enrolled, but 9 participants were not treated with the study drug.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants will be administered a placebo once daily for 6 weeks.</description>
        </group>
        <group group_id="P2">
          <title>TD-9855 Group 1</title>
          <description>Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
        </group>
        <group group_id="P3">
          <title>TD-9855 Group 2</title>
          <description>Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
                <participants group_id="P2" count="131"/>
                <participants group_id="P3" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="127"/>
                <participants group_id="P3" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="97"/>
                <participants group_id="P3" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants will be administered a placebo once daily for 6 weeks.</description>
        </group>
        <group group_id="B2">
          <title>TD-9855 Group 1</title>
          <description>Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
        </group>
        <group group_id="B3">
          <title>TD-9855 Group 2</title>
          <description>Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
            <count group_id="B2" value="131"/>
            <count group_id="B3" value="131"/>
            <count group_id="B4" value="392"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.8" lower_limit="18.0" upper_limit="65.0"/>
                    <measurement group_id="B2" value="48.0" lower_limit="19.0" upper_limit="65.0"/>
                    <measurement group_id="B3" value="43.2" lower_limit="19.0" upper_limit="65.0"/>
                    <measurement group_id="B4" value="45.7" lower_limit="18.0" upper_limit="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age (years)</title>
              <category_list>
                <category>
                  <title>18 - 45 Years of Age</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="73"/>
                    <measurement group_id="B4" value="179"/>
                  </measurement_list>
                </category>
                <category>
                  <title>46 - 65 Years of Age</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="213"/>
                  </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="123"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="123"/>
                    <measurement group_id="B4" value="369"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="112"/>
                    <measurement group_id="B4" value="333"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="110"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="107"/>
                    <measurement group_id="B4" value="324"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="131"/>
                    <measurement group_id="B4" value="392"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81.9" spread="17.64"/>
                    <measurement group_id="B2" value="83.2" spread="17.68"/>
                    <measurement group_id="B3" value="79.0" spread="17.27"/>
                    <measurement group_id="B4" value="81.4" spread="17.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.3" spread="6.85"/>
                    <measurement group_id="B2" value="164.5" spread="7.65"/>
                    <measurement group_id="B3" value="164.0" spread="8.49"/>
                    <measurement group_id="B4" value="164.0" spread="7.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.7" spread="6.24"/>
                    <measurement group_id="B2" value="30.7" spread="5.74"/>
                    <measurement group_id="B3" value="29.3" spread="5.59"/>
                    <measurement group_id="B4" value="30.2" spread="5.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries</title>
        <description>Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.</description>
        <time_frame>Baseline and Week 6</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants will be administered a placebo once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TD-9855 Group 1</title>
            <description>Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
          </group>
          <group group_id="O3">
            <title>TD-9855 Group 2</title>
            <description>Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries</title>
          <description>Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>percentage change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="122"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="0.17"/>
                    <measurement group_id="O2" value="-1.2" spread="0.18"/>
                    <measurement group_id="O3" value="-1.4" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1683</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0277</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fibromyalgia Impact Questionnaire (FIQ)</title>
        <description>FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.</description>
        <time_frame>Day 43 (End of study treatment)</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants will be administered a placebo once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TD-9855 Group 1</title>
            <description>Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
          </group>
          <group group_id="O3">
            <title>TD-9855 Group 2</title>
            <description>Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Fibromyalgia Impact Questionnaire (FIQ)</title>
          <description>FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="122"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" spread="1.75"/>
                    <measurement group_id="O2" value="42.4" spread="1.75"/>
                    <measurement group_id="O3" value="38.2" spread="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2637</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.57</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.48</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>2.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0097</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>-1.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGIC)</title>
        <description>PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.</description>
        <time_frame>Day 43 (End of study treatment)</time_frame>
        <population>Only participants with available data were used for this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants will be administered a placebo once daily for 6 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TD-9855 Group 1</title>
            <description>Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
          </group>
          <group group_id="O3">
            <title>TD-9855 Group 2</title>
            <description>Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGIC)</title>
          <description>PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.</description>
          <population>Only participants with available data were used for this analysis.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="126"/>
                <count group_id="O2" value="122"/>
                <count group_id="O3" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.11"/>
                    <measurement group_id="O2" value="2.9" spread="0.11"/>
                    <measurement group_id="O3" value="2.8" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0639</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0070</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 up to Day 63</time_frame>
      <desc>Only data from participants who received study drug or placebo is included here.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants will be administered a placebo once daily for 6 weeks.</description>
        </group>
        <group group_id="E2">
          <title>TD-9855 Group 1</title>
          <description>Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
        </group>
        <group group_id="E3">
          <title>TD-9855 Group 2</title>
          <description>Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Non-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="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient neurological symptoms of unknown etiology</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="71" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="78" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="90" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Macrocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Postural orthostatic tachycardia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Motion sickness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Blindness transient</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dental discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Infrequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Lip dry</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Lip pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Sluggishness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tenderness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Bacteriuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gingival infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Periumbilical abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Procedural dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increase</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Urinary sediment present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Blood creatine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Heart sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hypovitaminosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Salt craving</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Coccydynia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Invertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hyporeflexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Neurological symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hostility</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Illusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Thinking abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Cystitis interstitial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Stress urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Urine flow decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hypomenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Menstrual disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Menstruation delayed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </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="2" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Choking</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Skin hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="128"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="127"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="128"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Monitor</name_or_title>
      <organization>Theravance Biopharma</organization>
      <phone>1-855-633-8479</phone>
      <email>medinfo@theravance.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/NCT01693692
org study id: 0092
nct id: NCT01693692
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study study is to determine whether TD-9855 is effective in treating
      patients with fibromyalgia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries
time frame: Baseline and Week 6
description: Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
measure: Fibromyalgia Impact Questionnaire (FIQ)
time frame: Day 43 (End of study treatment)
description: FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.
measure: Patient Global Impression of Change (PGIC)
time frame: Day 43 (End of study treatment)
description: PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.
arm group label: TD-9855 Group 1
arm group type: Experimental
description: Group 1 to be dosed with TD-9855
arm group label: TD-9855 Group 2
arm group type: Experimental
description: Group 2 to be dosed with TD-9855
arm group label: Placebo
arm group type: Placebo Comparator
description: Group to be dosed with Placebo
intervention type: Drug
intervention name: TD-9855 Group 1
arm group label: TD-9855 Group 1
intervention type: Drug
intervention name: TD-9855 Group 2
arm group label: TD-9855 Group 2
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Medical Monitor
role: Study Director
affiliation: Theravance Biopharma
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No
ipd description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 