<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/NCT02234583</url>
  </required_header>
  <id_info>
    <org_study_id>DS5565-A-E312</org_study_id>
    <secondary_id>2013-005164-26</secondary_id>
    <nct_id>NCT02234583</nct_id>
  </id_info>
  <brief_title>An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia</brief_title>
  <official_title>An Open-label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label study of DS-5565 in subjects who either completed participation in a&#xD;
      preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430),&#xD;
      DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible&#xD;
      subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will&#xD;
      receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period.&#xD;
      After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on&#xD;
      protocol-specified criteria.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2015</start_date>
  <completion_date type="Actual">April 19, 2017</completion_date>
  <primary_completion_date type="Actual">April 19, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Daily Pain Score (ADPS) for DS-5565</measure>
    <time_frame>Day 0 (baseline) up to to Week 52 postdose</time_frame>
    <description>Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Much Improved or Better (≤2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change</measure>
    <time_frame>Week 52 postdose</time_frame>
    <description>Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with &quot;much improved or better&quot; status are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565</measure>
    <time_frame>Day 0 (baseline) up to Week 52 postdose</time_frame>
    <description>The HADS questionnaire is a self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale from 0 to 3, where higher scores indicate greater anxiety or depression. Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565</measure>
    <time_frame>Day 0 (baseline) up to Week 52 postdose</time_frame>
    <description>The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-36 (SF-36) Measure for DS-5565</measure>
    <time_frame>Day 0 (baseline) to Week 52 postdose</time_frame>
    <description>The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 physical component summary and mental component summary scales range from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) total scores at baseline and Week 52 are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565</measure>
    <time_frame>Day 0 (baseline) up to Week 52 postdose</time_frame>
    <description>Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week. For rollover participants, the baseline scores from the End-of-Tapering period in the preceding study are reported. For de novo participants, the baseline scores are derived from the 7 days prior to the start of treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2485</enrollment>
  <condition>Pain Associated With Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>DS-5565</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive 15 mg DS-5565 administered once or twice daily. Each participant's dose can be titrated up or down based on the investigator's decision. Analysis will be based on the dose modality at the time of data collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS-5565</intervention_name>
    <description>DS-5565 15 mg tablet for oral administration</description>
    <arm_group_label>DS-5565</arm_group_label>
    <other_name>Investigational product</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
          -  Completed participation (i.e. completed the End-of-Tapering visit) in a preceding&#xD;
             study of DS 5565 in FM (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311)&#xD;
&#xD;
          -  Women of child-bearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy during the study and for 4 weeks after study&#xD;
             completion&#xD;
&#xD;
          -  Able to complete subject-reported questionaires per the investigator's judgement&#xD;
&#xD;
          -  The subject must not have experienced any significant safety issues during the&#xD;
             preceding study that, in the investigator's judgment, would adversely impact the&#xD;
             subject's well-being in the long-term extension&#xD;
&#xD;
        De Novo Subjects&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Able to give written informed consent&#xD;
&#xD;
          -  Able to complete subject-reported questionnaires per the investigator's judgment&#xD;
&#xD;
          -  At screening, subjects must meet the 1990 American College of Rheumatology (ACR)&#xD;
             criteria for FM, i.e. widespread pain present for at least 3 months and pain in at&#xD;
             least 11 of 18 specific tender point sites. In addition, the 2010 ACR criteria must be&#xD;
             met:&#xD;
&#xD;
               -  Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5, or WPI&#xD;
                  3 to 6 and SS scale score ≥ 9&#xD;
&#xD;
               -  Symptoms have been present at a similar level for at least 3 months&#xD;
&#xD;
               -  The subject does not have a disorder that would otherwise explain the pain&#xD;
&#xD;
          -  ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to&#xD;
             first dose (based on completion of at least 4 daily pain diaries during the 7-day&#xD;
             baseline period)&#xD;
&#xD;
          -  Subject must have documented evidence of a fundoscopic examination (with pupil&#xD;
             dilation) within 12 months prior to screening or at screening&#xD;
&#xD;
          -  Women of child-bearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy during the study and for 4 weeks after study&#xD;
             completion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant unstable neurologic, psychiatric, ophthalmologic,&#xD;
             hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease&#xD;
             (e.g. severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction)&#xD;
             or any other concurrent disease during the preceding study (for rollover subjects) or&#xD;
             within 12 months prior to screening (for de novo subjects) that in the opinion of the&#xD;
             investigator would interfere with study participation or assessment of safety and&#xD;
             tolerability&#xD;
&#xD;
          -  Subjects who are at risk of suicide as defined by their responses to the C-SSRS or in&#xD;
             the opinion of the investigator.&#xD;
&#xD;
          -  Subjects with severe or uncontrolled depression that, in the judgment of the&#xD;
             investigator, makes the subject inappropriate for entry into the study&#xD;
&#xD;
          -  Subjects with pain due to other conditions (e.g. DPNP or post-herpetic neuralgia)&#xD;
             that, in the opinion of the investigator, would confound assessment or self-evaluation&#xD;
             of the pain associated with FM&#xD;
&#xD;
          -  Subjects with pain due to any widespread inflammatory musculoskeletal disorder (e.g.&#xD;
             rheumatoid arthritis, lupus) or widespread rheumatic disease other than FM.&#xD;
&#xD;
          -  Abuse or dependence of prescription medications, street drugs, or alcohol within the&#xD;
             last 1 year&#xD;
&#xD;
          -  A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within&#xD;
             the past 3 months&#xD;
&#xD;
          -  Known hypersensitivity to α2δ ligands or other components of the study medications&#xD;
&#xD;
          -  Pregnancy or breast-feeding, or intent to become pregnant during the study period&#xD;
&#xD;
          -  Abnormal investigative tests (i.e. ECGs) and laboratory values judged by the&#xD;
             investigator to be clinically significant at the End-of-Treatment visit (Visit - Week&#xD;
             13) in the preceding study (for rollover subjects) or at screening (for de novo&#xD;
             subjects), with particular focus on:&#xD;
&#xD;
        For De Novo Subjects Only&#xD;
&#xD;
          -  Unable to undergo pre-study washout of prohibited concomitant medications (as listed&#xD;
             in Section 5.2.1 of the protocol)&#xD;
&#xD;
          -  Current severe or uncontrolled major depressive disorder or anxiety disorders as&#xD;
             assessed by the Mini-international Neuropsychiatric Interview (MINI) interview&#xD;
             (Version 6.0) at screening are excluded, but mild to moderate major depression or&#xD;
             anxiety disorders are permitted provided that the investigator assesses the patient as&#xD;
             clinically stable and appropriate for entry into the study&#xD;
&#xD;
          -  Any diagnosis of lifetime bipolar disorder or psychotic disorder&#xD;
&#xD;
          -  Subject is currently enrolled in or has not yet completed at least 30 days since&#xD;
             ending another investigational device or drug study or is receiving other&#xD;
             investigational agents&#xD;
&#xD;
          -  Subject is an employee of the study center, an immediate family member* of an employee&#xD;
             of the study center, or an employee of Daiichi Sankyo, INC Research, or any of the&#xD;
             study vendors supporting this study. *(spouse, parent, child, or sibling, whether&#xD;
             biological or legally adopted)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Spring Valley</city>
        <state>California</state>
        <zip>91978</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cromwell</city>
        <state>Connecticut</state>
        <zip>06416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leesburg</city>
        <state>Florida</state>
        <zip>34748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Royal Palm Beach</city>
        <state>Florida</state>
        <zip>33411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33709</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Smyrna</city>
        <state>Georgia</state>
        <zip>30080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bolingbrook</city>
        <state>Illinois</state>
        <zip>60490</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gurnee</city>
        <state>Illinois</state>
        <zip>60031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melrose Park</city>
        <state>Illinois</state>
        <zip>60160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oak Brook</city>
        <state>Illinois</state>
        <zip>60523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Evansville</city>
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        <zip>47714</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <zip>50265</zip>
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  <location>
    <facility>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Shawnee Mission</city>
        <state>Kansas</state>
        <zip>66218</zip>
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  <location>
    <facility>
      <address>
        <city>Wichita</city>
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        <zip>67205</zip>
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  <location>
    <facility>
      <address>
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        <zip>67207</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Paducah</city>
        <state>Kentucky</state>
        <zip>42003</zip>
        <country>United States</country>
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  <location>
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        <city>Lake Charles</city>
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        <zip>70601</zip>
        <country>United States</country>
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  <location>
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        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
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  <location>
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        <state>Massachusetts</state>
        <zip>02720</zip>
        <country>United States</country>
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  <location>
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        <state>Massachusetts</state>
        <zip>02740</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>Massachusetts</state>
        <zip>02472</zip>
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  <location>
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      <address>
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        <zip>39531</zip>
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  <location>
    <facility>
      <address>
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        <zip>63042</zip>
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  <location>
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      <address>
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  <location>
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        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
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  <location>
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      <address>
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        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>New Jersey</state>
        <zip>08009</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Blackwood</city>
        <state>New Jersey</state>
        <zip>08012</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <zip>87109</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <zip>11230</zip>
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  <location>
    <facility>
      <address>
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        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10168</zip>
        <country>United States</country>
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  <location>
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        <zip>11758</zip>
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  <location>
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        <zip>28210</zip>
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  <location>
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        <zip>27408</zip>
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  <location>
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      <address>
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        <zip>27262</zip>
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  <location>
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  <location>
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  <location>
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  <location>
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        <zip>45242</zip>
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  <location>
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      <address>
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        <zip>45417</zip>
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  <location>
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      <address>
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        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
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  <location>
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      <address>
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        <state>Ohio</state>
        <zip>44863</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>Ohio</state>
        <zip>44094</zip>
        <country>United States</country>
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  <location>
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        <state>Oklahoma</state>
        <zip>73103</zip>
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  <location>
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        <state>Oklahoma</state>
        <zip>74104</zip>
        <country>United States</country>
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  <location>
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        <zip>97404</zip>
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  <location>
    <facility>
      <address>
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        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
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  <location>
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        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>Oregon</state>
        <zip>97301</zip>
        <country>United States</country>
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  <location>
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        <city>Tipton</city>
        <state>Pennsylvania</state>
        <zip>16684</zip>
        <country>United States</country>
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  <location>
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      <address>
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        <state>Pennsylvania</state>
        <zip>19610</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Fountain Inn</city>
        <state>South Carolina</state>
        <zip>29644</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
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  <location>
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      <address>
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        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
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  <location>
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        <state>Tennessee</state>
        <zip>37919</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>New Tazewell</city>
        <state>Tennessee</state>
        <zip>37836</zip>
        <country>United States</country>
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  <location>
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      <address>
        <city>Tullahoma</city>
        <state>Tennessee</state>
        <zip>37388</zip>
        <country>United States</country>
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  <location>
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        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
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  <location>
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      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79424</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
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        <state>Texas</state>
        <zip>78232</zip>
        <country>United States</country>
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  <location>
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        <state>Utah</state>
        <zip>84102</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23454</zip>
        <country>United States</country>
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  <location>
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      <address>
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        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
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  <location>
    <facility>
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        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Wenatchee</city>
        <state>Washington</state>
        <zip>98801</zip>
        <country>United States</country>
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  <location>
    <facility>
      <address>
        <city>Camperdown</city>
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        <country>Australia</country>
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  <location>
    <facility>
      <address>
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        <country>Australia</country>
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  <location>
    <facility>
      <address>
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        <country>Australia</country>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
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  <location>
    <facility>
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        <zip>4075</zip>
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  <location>
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  <location>
    <facility>
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  <location>
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  <location>
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  <location>
    <facility>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
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  <location>
    <facility>
      <address>
        <city>Senftenberg</city>
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  <location>
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        <city>Vienna</city>
        <zip>1090</zip>
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  <location>
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  <location>
    <facility>
      <address>
        <city>Pleven</city>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
        <city>Sevlievo</city>
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  <location>
    <facility>
      <address>
        <city>Sofia</city>
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  <location>
    <facility>
      <address>
        <city>Targovishte</city>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
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  <location>
    <facility>
      <address>
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  <location>
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  <location>
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        <country>Canada</country>
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  <location>
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        <state>Ontario</state>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <state>Ontario</state>
        <country>Canada</country>
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  <location>
    <facility>
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  <location>
    <facility>
      <address>
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        <country>Canada</country>
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  <location>
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        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <state>Ontario</state>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <state>Ontario</state>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
        <city>Sarnia</city>
        <state>Ontario</state>
        <zip>N7T 4X3</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <country>Canada</country>
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  <location>
    <facility>
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        <state>Ontario</state>
        <zip>M3J 2C5</zip>
        <country>Canada</country>
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  <location>
    <facility>
      <address>
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        <state>Ontario</state>
        <country>Canada</country>
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  <location>
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        <zip>H9R 3J1</zip>
        <country>Canada</country>
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  <location>
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      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Antofagasta</city>
        <state>Region 11</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Puerto Varas</city>
        <state>Region X</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chocen</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pilsen</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ricany</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rychnov nad Kneznou</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aalborg</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tallinn</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tartu</city>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hyvinkaa</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kuopio</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Etienne</city>
        <state>Cedex</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Douai</city>
        <state>Nord</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Elancourt</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bohlen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hannover</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stadtroda</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Balassagyarmat</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nyiregyhaza</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baldone</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Balvi</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Jekabpils</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liepaja</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ogre</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ventspils</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaunas</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Klaipeda</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vilnius</city>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamilton</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nelson</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tauranga</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alesund</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamar</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hønefoss</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Klofta</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lillehammer</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stavanger</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Elblag</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nadarzyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nowa Sol</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torun</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tychy</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aveiro</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guimaraes</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vila Nova de Gaia</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bacau</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Targu Mures</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krasnoyarsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nizhniy Novgarad</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stavropol</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Banska Bystrica</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dubnica nad Vahom</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Galanta</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krompachy</city>
        <zip>05342</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Piešťany</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Presov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Slovenj Gradec</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bayview</city>
        <state>Chatsworth</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johannesburg</city>
        <state>Gautang</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pretoria</city>
        <state>Gautang</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durban</city>
        <state>Kwazulu Natal</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Somerset West</city>
        <state>Western Cape</state>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stellenbosch</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruna</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dnipropetrovsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kherson</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vinnytsia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zaporizhzhia</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Penzance</city>
        <state>Cornwall</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chesterfield</city>
        <state>Derbyshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Romford</city>
        <state>Essex</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Blackpool</city>
        <state>Lancashire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Thornton-Cleveleys</city>
        <state>Lancashire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wigan</city>
        <state>Lancashire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stourton</city>
        <state>Leeds</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salford</city>
        <state>Manchester</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Southport</city>
        <state>Merseyside</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wellingborough</city>
        <state>Northamptonshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belfast</city>
        <state>Northern Ireland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cannock</city>
        <state>Staffordshire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Shields</city>
        <state>Tyne And Wear</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atherstone</city>
        <state>Warwickshire</state>
        <zip>CV9 1EU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torpoint</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>New Zealand</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>June 24, 2020</results_first_submitted>
  <results_first_submitted_qc>July 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2020</results_first_posted>
  <disposition_first_submitted>March 15, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>March 15, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 19, 2018</disposition_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 14, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT02234583/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 2485 participants who met all inclusion and no exclusion criteria enrolled from 04 Feb 2015 to 19 Apr 2017 at 406 clinic sites. Of the 2485 enrolled, 397 discontinued prior to randomization. A total of 2088 participants received study treatment.</recruitment_details>
      <pre_assignment_details>Participants who completed the double-blind studies of DS-5565 in fibromyalgia were eligible to Rollover to this open-label extension study (referred to as Rollover participants). Participants who did not participate in a preceding double-blind study (referred to as De Novo participants) could be enrolled at the discretion of the Sponsor.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>DS-5565 15 mg QD Modal</title>
          <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo QD modal.</description>
        </group>
        <group group_id="P2">
          <title>DS-5565 15 mg BID Modal</title>
          <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo twice daily (BID) modal.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="847"/>
                <participants group_id="P2" count="1241"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="434"/>
                <participants group_id="P2" count="685"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="413"/>
                <participants group_id="P2" count="556"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="156"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="157"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="103"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="97"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographic and baseline characteristics are derived from the Safety Analysis Set.</population>
      <group_list>
        <group group_id="B1">
          <title>DS-5565 15 mg QD Modal</title>
          <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo QD modal.</description>
        </group>
        <group group_id="B2">
          <title>DS-5565 15 mg BID Modal</title>
          <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). This group includes both rollover and De Novo BID modal.</description>
        </group>
        <group group_id="B3">
          <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="847"/>
            <count group_id="B2" value="1241"/>
            <count group_id="B3" value="2088"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="750"/>
                    <measurement group_id="B2" value="1128"/>
                    <measurement group_id="B3" value="1878"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.4" spread="11.18"/>
                    <measurement group_id="B2" value="49.3" spread="11.94"/>
                    <measurement group_id="B3" value="50.2" spread="11.68"/>
                  </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="770"/>
                    <measurement group_id="B2" value="1130"/>
                    <measurement group_id="B3" value="1900"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="188"/>
                  </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="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="113"/>
                    <measurement group_id="B3" value="195"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="740"/>
                    <measurement group_id="B2" value="1101"/>
                    <measurement group_id="B3" value="1841"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="37"/>
                  </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="569"/>
                    <measurement group_id="B2" value="913"/>
                    <measurement group_id="B3" value="1879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Czechia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Portugal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovakia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Slovenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lithuania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serbia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Norway</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Daily Pain Score (ADPS) for DS-5565</title>
        <description>Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.</description>
        <time_frame>Day 0 (baseline) up to to Week 52 postdose</time_frame>
        <population>Average daily pain score was assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Rollover DS-5565 15 mg QD Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O2">
            <title>Rollover DS-5565 15 mg BID Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O3">
            <title>De Novo DS-5565 15 mg QD Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O4">
            <title>De Novo DS-5565 15 mg BID Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Daily Pain Score (ADPS) for DS-5565</title>
          <description>Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.</description>
          <population>Average daily pain score was assessed in the Safety Analysis Set.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="578"/>
                <count group_id="O2" value="962"/>
                <count group_id="O3" value="269"/>
                <count group_id="O4" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="562"/>
                    <count group_id="O2" value="940"/>
                    <count group_id="O3" value="264"/>
                    <count group_id="O4" value="274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="2.23"/>
                    <measurement group_id="O2" value="5.58" spread="2.22"/>
                    <measurement group_id="O3" value="7.08" spread="1.40"/>
                    <measurement group_id="O4" value="7.38" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="398"/>
                    <count group_id="O2" value="809"/>
                    <count group_id="O3" value="165"/>
                    <count group_id="O4" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" spread="2.11"/>
                    <measurement group_id="O2" value="4.36" spread="2.32"/>
                    <measurement group_id="O3" value="3.21" spread="2.20"/>
                    <measurement group_id="O4" value="4.06" spread="2.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="340"/>
                    <count group_id="O2" value="661"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.28" spread="2.08"/>
                    <measurement group_id="O2" value="4.24" spread="2.35"/>
                    <measurement group_id="O3" value="3.0" spread="2.14"/>
                    <measurement group_id="O4" value="4.0" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="552"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.20" spread="2.06"/>
                    <measurement group_id="O2" value="4.25" spread="2.34"/>
                    <measurement group_id="O3" value="2.74" spread="2.23"/>
                    <measurement group_id="O4" value="3.95" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="470"/>
                    <count group_id="O3" value="121"/>
                    <count group_id="O4" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.22" spread="2.16"/>
                    <measurement group_id="O2" value="4.25" spread="2.37"/>
                    <measurement group_id="O3" value="2.46" spread="2.15"/>
                    <measurement group_id="O4" value="3.80" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="245"/>
                    <count group_id="O2" value="432"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.20" spread="2.18"/>
                    <measurement group_id="O2" value="4.26" spread="2.42"/>
                    <measurement group_id="O3" value="2.31" spread="1.94"/>
                    <measurement group_id="O4" value="3.80" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Much Improved or Better (≤2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change</title>
        <description>Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with &quot;much improved or better&quot; status are reported.</description>
        <time_frame>Week 52 postdose</time_frame>
        <population>Patient Global Impression of Change was assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Rollover DS-5565 15 mg QD Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O2">
            <title>Rollover DS-5565 15 mg BID Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O3">
            <title>De Novo DS-5565 15 mg QD Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O4">
            <title>De Novo DS-5565 15 mg BID Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Much Improved or Better (≤2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change</title>
          <description>Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with &quot;much improved or better&quot; status are reported.</description>
          <population>Patient Global Impression of Change was assessed in the Safety Analysis Set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="578"/>
                <count group_id="O2" value="962"/>
                <count group_id="O3" value="269"/>
                <count group_id="O4" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208"/>
                    <measurement group_id="O2" value="333"/>
                    <measurement group_id="O3" value="96"/>
                    <measurement group_id="O4" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565</title>
        <description>The HADS questionnaire is a self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale from 0 to 3, where higher scores indicate greater anxiety or depression. Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity.</description>
        <time_frame>Day 0 (baseline) up to Week 52 postdose</time_frame>
        <population>HADS-Depression and Anxiety was assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Rollover DS-5565 15 mg QD Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.&#xD;
DS-5565: DS-5565 15 mg tablet for oral administration</description>
          </group>
          <group group_id="O2">
            <title>Rollover DS-5565 15 mg BID Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.&#xD;
DS-5565: DS-5565 15 mg tablet for oral administration</description>
          </group>
          <group group_id="O3">
            <title>De Novo DS-5565 15 mg QD Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.&#xD;
DS-5565: DS-5565 15 mg tablet for oral administration</description>
          </group>
          <group group_id="O4">
            <title>De Novo DS-5565 15 mg QID Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.&#xD;
DS-5565: DS-5565 15 mg tablet for oral administration</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565</title>
          <description>The HADS questionnaire is a self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale from 0 to 3, where higher scores indicate greater anxiety or depression. Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity.</description>
          <population>HADS-Depression and Anxiety was assessed in the Safety Analysis Set.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="578"/>
                <count group_id="O2" value="962"/>
                <count group_id="O3" value="269"/>
                <count group_id="O4" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anxiety Subscale Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="520"/>
                    <count group_id="O2" value="894"/>
                    <count group_id="O3" value="266"/>
                    <count group_id="O4" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="3.86"/>
                    <measurement group_id="O2" value="7.2" spread="4.05"/>
                    <measurement group_id="O3" value="6.9" spread="3.97"/>
                    <measurement group_id="O4" value="7.4" spread="4.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety Subscale Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="539"/>
                    <count group_id="O3" value="124"/>
                    <count group_id="O4" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="3.71"/>
                    <measurement group_id="O2" value="7.0" spread="4.03"/>
                    <measurement group_id="O3" value="4.4" spread="3.29"/>
                    <measurement group_id="O4" value="5.7" spread="3.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression Subscale Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="520"/>
                    <count group_id="O2" value="894"/>
                    <count group_id="O3" value="266"/>
                    <count group_id="O4" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="4.18"/>
                    <measurement group_id="O2" value="6.3" spread="4.34"/>
                    <measurement group_id="O3" value="5.6" spread="4.06"/>
                    <measurement group_id="O4" value="5.7" spread="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression Subscale Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="539"/>
                    <count group_id="O3" value="124"/>
                    <count group_id="O4" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="3.47"/>
                    <measurement group_id="O2" value="4.8" spread="4.01"/>
                    <measurement group_id="O3" value="2.8" spread="3.11"/>
                    <measurement group_id="O4" value="3.9" spread="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565</title>
        <description>The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.</description>
        <time_frame>Day 0 (baseline) up to Week 52 postdose</time_frame>
        <population>EQ-5D was assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Rollover DS-5565 15 mg QD Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O2">
            <title>Rollover DS-5565 15 mg BID Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O3">
            <title>De Novo DS-5565 15 mg QD Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O4">
            <title>De Novo DS-5565 15 mg BID Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
        </group_list>
        <measure>
          <title>EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565</title>
          <description>The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.</description>
          <population>EQ-5D was assessed in the Safety Analysis Set.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="578"/>
                <count group_id="O2" value="962"/>
                <count group_id="O3" value="269"/>
                <count group_id="O4" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="520"/>
                    <count group_id="O2" value="894"/>
                    <count group_id="O3" value="266"/>
                    <count group_id="O4" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="0.17"/>
                    <measurement group_id="O2" value="0.64" spread="0.19"/>
                    <measurement group_id="O3" value="0.62" spread="0.16"/>
                    <measurement group_id="O4" value="0.61" spread="0.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="539"/>
                    <count group_id="O3" value="124"/>
                    <count group_id="O4" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.16"/>
                    <measurement group_id="O2" value="0.70" spread="0.20"/>
                    <measurement group_id="O3" value="0.81" spread="0.15"/>
                    <measurement group_id="O4" value="0.77" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form-36 (SF-36) Measure for DS-5565</title>
        <description>The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 physical component summary and mental component summary scales range from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) total scores at baseline and Week 52 are reported.</description>
        <time_frame>Day 0 (baseline) to Week 52 postdose</time_frame>
        <population>SF-36 was assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Rollover DS-5565 15 mg QD Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O2">
            <title>Rollover DS-5565 15 mg BID Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O3">
            <title>De Novo DS-5565 15 mg QD Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O4">
            <title>De Novo DS-5565 15 mg BID Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form-36 (SF-36) Measure for DS-5565</title>
          <description>The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 physical component summary and mental component summary scales range from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) total scores at baseline and Week 52 are reported.</description>
          <population>SF-36 was assessed in the Safety Analysis Set.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="578"/>
                <count group_id="O2" value="962"/>
                <count group_id="O3" value="269"/>
                <count group_id="O4" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Component Summary Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="520"/>
                    <count group_id="O2" value="894"/>
                    <count group_id="O3" value="266"/>
                    <count group_id="O4" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.91" spread="8.86"/>
                    <measurement group_id="O2" value="35.13" spread="8.55"/>
                    <measurement group_id="O3" value="34.41" spread="8.58"/>
                    <measurement group_id="O4" value="32.12" spread="7.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Component Summary Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="539"/>
                    <count group_id="O3" value="124"/>
                    <count group_id="O4" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.96" spread="8.52"/>
                    <measurement group_id="O2" value="39.09" spread="9.38"/>
                    <measurement group_id="O3" value="45.61" spread="9.63"/>
                    <measurement group_id="O4" value="42.31" spread="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="520"/>
                    <count group_id="O2" value="894"/>
                    <count group_id="O3" value="266"/>
                    <count group_id="O4" value="270"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.12" spread="10.19"/>
                    <measurement group_id="O2" value="47.76" spread="11.15"/>
                    <measurement group_id="O3" value="47.54" spread="10.98"/>
                    <measurement group_id="O4" value="47.92" spread="11.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mental Component Summary Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="539"/>
                    <count group_id="O3" value="124"/>
                    <count group_id="O4" value="142"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.63" spread="9.61"/>
                    <measurement group_id="O2" value="49.15" spread="11.24"/>
                    <measurement group_id="O3" value="52.75" spread="8.02"/>
                    <measurement group_id="O4" value="50.49" spread="10.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565</title>
        <description>Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week. For rollover participants, the baseline scores from the End-of-Tapering period in the preceding study are reported. For de novo participants, the baseline scores are derived from the 7 days prior to the start of treatment.</description>
        <time_frame>Day 0 (baseline) up to Week 52 postdose</time_frame>
        <population>Average Daily Sleep Interference Score was assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Rollover DS-5565 15 mg QD Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O2">
            <title>Rollover DS-5565 15 mg BID Modal</title>
            <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309 [NCT02146430], DS5565-A-E310 [NCT02187471], or DS5565-A-E311 [NCT02187159]) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O3">
            <title>De Novo DS-5565 15 mg QD Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
          <group group_id="O4">
            <title>De Novo DS-5565 15 mg BID Modal</title>
            <description>Participants with no prior exposure to DS-5565 and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to twice daily (BID). Participants were reported by their modal dose or dose received most frequently.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565</title>
          <description>Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week. For rollover participants, the baseline scores from the End-of-Tapering period in the preceding study are reported. For de novo participants, the baseline scores are derived from the 7 days prior to the start of treatment.</description>
          <population>Average Daily Sleep Interference Score was assessed in the Safety Analysis Set.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="578"/>
                <count group_id="O2" value="962"/>
                <count group_id="O3" value="269"/>
                <count group_id="O4" value="279"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="562"/>
                    <count group_id="O2" value="940"/>
                    <count group_id="O3" value="264"/>
                    <count group_id="O4" value="274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.84" spread="2.41"/>
                    <measurement group_id="O2" value="4.74" spread="2.52"/>
                    <measurement group_id="O3" value="6.71" spread="1.70"/>
                    <measurement group_id="O4" value="6.82" spread="1.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="398"/>
                    <count group_id="O2" value="809"/>
                    <count group_id="O3" value="165"/>
                    <count group_id="O4" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.56" spread="2.16"/>
                    <measurement group_id="O2" value="3.18" spread="2.50"/>
                    <measurement group_id="O3" value="2.50" spread="2.15"/>
                    <measurement group_id="O4" value="3.13" spread="2.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="340"/>
                    <count group_id="O2" value="661"/>
                    <count group_id="O3" value="148"/>
                    <count group_id="O4" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.34" spread="1.96"/>
                    <measurement group_id="O2" value="3.09" spread="2.50"/>
                    <measurement group_id="O3" value="2.36" spread="2.18"/>
                    <measurement group_id="O4" value="3.19" spread="2.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="552"/>
                    <count group_id="O3" value="126"/>
                    <count group_id="O4" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="1.98"/>
                    <measurement group_id="O2" value="3.09" spread="2.50"/>
                    <measurement group_id="O3" value="2.19" spread="2.20"/>
                    <measurement group_id="O4" value="3.11" spread="2.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="470"/>
                    <count group_id="O3" value="121"/>
                    <count group_id="O4" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.32" spread="2.07"/>
                    <measurement group_id="O2" value="3.22" spread="2.56"/>
                    <measurement group_id="O3" value="1.87" spread="2.05"/>
                    <measurement group_id="O4" value="3.02" spread="2.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="245"/>
                    <count group_id="O2" value="432"/>
                    <count group_id="O3" value="109"/>
                    <count group_id="O4" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.22" spread="2.06"/>
                    <measurement group_id="O2" value="3.19" spread="2.63"/>
                    <measurement group_id="O3" value="1.79" spread="1.86"/>
                    <measurement group_id="O4" value="3.09" spread="2.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after last dose, up to 2 years 3 months.</time_frame>
      <desc>A TEAE was any adverse event that emerged on or after the first dosing of open-label extension (OLE) medication and during study treatment up to 4 weeks after the last dose of OLE medication (having been absent prior to treatment) or worsened relative to the pre-OLE treatment state.</desc>
      <group_list>
        <group group_id="E1">
          <title>DS-5565 15 mg QD Modal</title>
          <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo QD modal.</description>
        </group>
        <group group_id="E2">
          <title>DS-5565 15 mg BID Modal</title>
          <description>Participants received DS-5565 in a preceding Phase 3 study of DS-5565 in fibromyalgia (DS5565-A-E309, DS5565-A-E310, or DS5565-A-E311) and received 15 mg DS-5565 administered once daily (QD) for the first 3 weeks. After 3 weeks, participants could be titrated to BID. This group includes both rollover and De Novo twice daily (BID) modal.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Spine malformation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </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="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Incarcerated umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Chronic hepatitis C</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Gastroenteritis salmonella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Infectious colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Acetabulum fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Anaesthetic complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Burns third degree</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Humerous fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Periprosthetic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Blood creatinine phosphokinase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Breast cancer stage III</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Castleman's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Fibroadenoma of breast</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Uterine cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Chronic inflammatory demyelinating polyradiculoneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Hyperemesis gravidarum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Suicidal behaviour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Bereavement</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Blood pressure fluctuation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="669" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="1056" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="113" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="97" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="135" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="82" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="134" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="107" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="110" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="89" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="207" subjects_at_risk="1241"/>
              </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="35" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="89" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="88" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="134" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="148" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="123" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="158" subjects_at_risk="1241"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="130" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="1241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="847"/>
                <counts group_id="E2" subjects_affected="63" subjects_at_risk="1241"/>
              </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>Daiichi Sankyo US Contact for Clinical Trial Results</name_or_title>
      <organization>Daiichi Sankyo, Inc.</organization>
      <phone>1-908-992-6400</phone>
      <email>CTRinfo@DSI.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/NCT02234583
org study id: DS5565-A-E312
secondary id: 2013-005164-26
nct id: NCT02234583
lead sponsor: 
has dmc: Yes
This is an open-label study of DS-5565 in subjects who either completed participation in a
      preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e. DS5565-A-E309 (NCT02146430),
      DS5565-A-E310 (NCT02187471), or DS5565-A-E311 (NCT02187159) or are de novo subjects. Eligible
      subjects will be assigned to receive open-label DS-5565 for 52 weeks. All subjects will
      receive DS-5565 15 mg once daily (QD) for the first three weeks of the treatment period.
      After three weeks, subjects may be titrated to 15 mg twice daily (BID) based on
      protocol-specified criteria.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average Daily Pain Score (ADPS) for DS-5565
time frame: Day 0 (baseline) up to to Week 52 postdose
description: Average of daily pain scores are reported by the participant and best describes his or her worst pain over the previous 24 hours. A daily pain score has a scale of 0 = no pain to 10 = worst possible pain.
measure: Number of Participants With Much Improved or Better (≤2) Status in Status at Week 52 As Assessed by the Patient-Rated Global Impression of Change
time frame: Week 52 postdose
description: Patient-rated global impression of change (PGIC) on a categorical scale from 1 = very much improved to 7 = very much worse. The number of participants with "much improved or better" status are reported.
measure: Hospital Anxiety Depression Scale (HADS) Depression and Anxiety Scores for DS-5565
time frame: Day 0 (baseline) up to Week 52 postdose
description: The HADS questionnaire is a self-assessment scale to assess symptoms of anxiety and depression. The instrument consists of 7 questions related to anxiety and 7 related to depression, each rated on a 4-point scale from 0 to 3, where higher scores indicate greater anxiety or depression. Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 to 21, where higher scores indicate greater severity.
measure: EuroQol Five Dimensions Questionnaire (EQ-5D) Measure for DS-5565
time frame: Day 0 (baseline) up to Week 52 postdose
description: The EQ-5D is an instrument that shows high construct validity and responsiveness in patients with chronic pain and has been used specifically in fibromyalgia. The EQ-5D includes a descriptive section with 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that are combined into an overall health utilities index, and an NRS (100 mm VAS) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health.
measure: Short Form-36 (SF-36) Measure for DS-5565
time frame: Day 0 (baseline) to Week 52 postdose
description: The SF-36 is a 36-question health survey that measures functional health and well-being from the participant's point of view. It is a measure of physical and mental health used across various disease areas, including fibromyalgia. The SF-36 physical component summary and mental component summary scales range from 0 to 100 where lower scores indicate more disability (worse health) and higher scores represent less disability (better health). The physical component summary (PCS) and mental component summary (MCS) total scores at baseline and Week 52 are reported.
measure: Pain-Associated Sleep Interference as Assessed by Average Daily Sleep Interference Score (ADSIS) for DS-5565
time frame: Day 0 (baseline) up to Week 52 postdose
description: Pain-associated sleep interference was assessed using electronic daily diaries using an 11-point numeric rating scale (NRS) for pain, ranging from 0 (pain does not interfere with sleep) to 10 (pain completely interferes with sleep, unable to sleep). ADSIS is the mean value of all available recordings of the respective week. For rollover participants, the baseline scores from the End-of-Tapering period in the preceding study are reported. For de novo participants, the baseline scores are derived from the 7 days prior to the start of treatment.
arm group label: DS-5565
arm group type: Experimental
description: Participants receive 15 mg DS-5565 administered once or twice daily. Each participant's dose can be titrated up or down based on the investigator's decision. Analysis will be based on the dose modality at the time of data collection.
intervention type: Drug
intervention name: DS-5565
description: DS-5565 15 mg tablet for oral administration
arm group label: DS-5565
other name: Investigational product
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Leader
role: Study Director
affiliation: Daiichi Sankyo, Inc.
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country: Australia
country: Austria
country: Bulgaria
country: Canada
country: Chile
country: Czechia
country: Denmark
country: Estonia
country: Finland
country: France
country: Germany
country: Hungary
country: Latvia
country: Lithuania
country: New Zealand
country: Norway
country: Poland
country: Portugal
country: Puerto Rico
country: Romania
country: Russian Federation
country: Serbia
country: Slovakia
country: Slovenia
country: South Africa
country: Spain
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
ipd url: https://vivli.org/ourmember/daiichi-sankyo/
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 