<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/NCT02187159</url>
  </required_header>
  <id_info>
    <org_study_id>DS5565-A-E311</org_study_id>
    <secondary_id>2013-005163-10</secondary_id>
    <nct_id>NCT02187159</nct_id>
  </id_info>
  <brief_title>Treatment of Pain Associated With Fibromyalgia</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this trial is to compare change in weekly average daily pain score&#xD;
      (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus&#xD;
      placebo. Weekly ADPS is based on daily pain scores reported by the participant that best&#xD;
      describes his or her worst pain over the previous 24 hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">July 7, 2016</completion_date>
  <primary_completion_date type="Actual">July 7, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 postdose</time_frame>
    <description>The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Answered &quot;Much Improved or Better&quot; on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Week 13 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; (≤2 scores) are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 postdose</time_frame>
    <description>The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome.&#xD;
For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Week 13 postdose</time_frame>
    <description>The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 postdose</time_frame>
    <description>MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).&#xD;
For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 postdose</time_frame>
    <description>The HADS questionnaire is a reliable, widely-used 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 (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 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 scale ranges 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) scores are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 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) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome.&#xD;
For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Week 13 postdose</time_frame>
    <description>The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Baseline up to Week 13 postdose</time_frame>
    <description>The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo</measure>
    <time_frame>Week 1 to Week 13 postdose</time_frame>
    <description>Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1270</enrollment>
  <condition>Pain Associated With Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>DS-5565 QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DS-5565 BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregabalin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants take one pregabalin capsule and one placebo tablet BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants take one each of placebo tablet and capsule BID</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 BID</arm_group_label>
    <arm_group_label>DS-5565 QD</arm_group_label>
    <other_name>mirogabalin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin</intervention_name>
    <description>Pregabalin 150 mg capsule for oral administration</description>
    <arm_group_label>Pregabalin</arm_group_label>
    <other_name>Lyrica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo tablet</intervention_name>
    <description>Placebo tablet (matching DS5565) for oral administration</description>
    <arm_group_label>DS-5565 QD</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Pregabalin</arm_group_label>
    <other_name>Placebo matching DS-5565</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo capsule</intervention_name>
    <description>Placebo capsule (matching pregabalin) for oral administration</description>
    <arm_group_label>DS-5565 BID</arm_group_label>
    <arm_group_label>DS-5565 QD</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo matching pregabalin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#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 3 to&#xD;
             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;
             randomization (based on completion of at least 4 daily pain diaries during the 7-day&#xD;
             baseline period prior to randomization)&#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 within 12 months prior to screening that in the&#xD;
             opinion of the investigator would interfere with study participation or assessment of&#xD;
             safety and tolerability&#xD;
&#xD;
          -  Anticipation of initiation or significant change to normal daily exercise routines or&#xD;
             need for ongoing use of concomitant medications or non-pharmacological pain management&#xD;
             techniques that may confound assessments of efficacy and/or safety&#xD;
&#xD;
          -  Unable to undergo pre-study washout of prohibited concomitant medications&#xD;
&#xD;
          -  Subjects who are at risk of suicide as defined by their responses to the&#xD;
             Columbia-Suicide Severity Rating Scale (C-SSRS) or in the opinion of the investigator.&#xD;
             Note: Patients answering &quot;yes&quot; to any of the questions about active suicidal&#xD;
             ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS&#xD;
             Suicide Ideation section - Questions 3, 4, or 5; C-SSRS Suicidal Behavior section, any&#xD;
             of the suicide behaviors questions). Such patients should be referred immediately to a&#xD;
             mental health professional for appropriate evaluation.&#xD;
&#xD;
          -  Current severe or uncontrolled major depressive disorder or anxiety disorders as&#xD;
             assessed by the Mini-international Neuropsychiatric Interview (MINI) mild to moderate&#xD;
             major depression or anxiety disorders are permitted provided that the investigator&#xD;
             assesses the patient as clinically stable and appropriate for entry into the study.&#xD;
&#xD;
          -  Any diagnosis of lifetime bipolar disorder or psychotic disorder&#xD;
&#xD;
          -  Subjects with pain due to other conditions (e.g. diabetic peripheral neuropathic pain&#xD;
             or post-herpetic neuralgia) that in the opinion of the investigator, would confound&#xD;
             assessment or self-evaluation 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;
          -  Any history of a malignancy other than basal cell carcinoma within the past 5 years&#xD;
&#xD;
          -  A diagnosis of untreated sleep apnea or initiation of treatment for sleep apnea within&#xD;
             the past 3 months&#xD;
&#xD;
          -  Pregnancy or breast-feeding, or intent to become pregnant during the study period&#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;
          -  Known hypersensitivity to alpha2-delta (α2δ) ligands or other components of the study&#xD;
             medications. Note: Prior exposure to DS-5565 is allowed, as long as hypersensitivity&#xD;
             to DS-5565 was not observed.&#xD;
&#xD;
          -  Subjects who are unlikely to comply with the protocol (e.g. uncooperative attitude,&#xD;
             inability to return for subsequent visits) and/or otherwise considered by the&#xD;
             investigator to be unlikely to complete the study.&#xD;
&#xD;
          -  Abnormal investigative tests (i.e. electrocardiograms [ECGs]) and laboratory values&#xD;
             judged by the investigator to be clinically significant at screening, with particular&#xD;
             focus on: a. Abnormal renal function defined as calculated creatinine clearance (CrCl)&#xD;
             &lt; 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault&#xD;
             equation; blood urea nitrogen&gt; 1.5 × upper limit of normal (ULN); creatine kinase &gt;&#xD;
             3.0 × ULN; serum creatinine &gt; 1.6 mg/dL (&gt; 141.4 μmol/L); b. Abnormal liver function&#xD;
             defined as aspartate aminotransferase (AST) &gt; 2.0 × ULN, alanine aminotransferase&#xD;
             (ALT) &gt; 2.0 × ULN; alkaline phosphatase &gt; 1.5 × ULN; total bilirubin&gt; 1.2 × ULN. If a&#xD;
             subject has total bilirubin &gt; 1.2 ULN, unconjugated and conjugated bilirubin fractions&#xD;
             should be analyzed and only subjects documented to have Gilbert's syndrome may be&#xD;
             enrolled.&#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>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>85027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</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>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Richmond</city>
        <state>California</state>
        <zip>94806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <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>Simi Valley</city>
        <state>California</state>
        <zip>93065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34208</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>DeBary</city>
        <state>Florida</state>
        <zip>32713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</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>Homestead</city>
        <state>Florida</state>
        <zip>33030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <zip>33161</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>Plant City</city>
        <state>Florida</state>
        <zip>33563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
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  <location>
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  <location>
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  <location>
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  <location>
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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>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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        <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>Cluj Napoca</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oradea</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Targu Mures</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ivanovo</city>
        <country>Russian Federation</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 Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orenburgsky</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pyatigorski</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Petersburg</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>Vladikavkaz</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yaroslav</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Banska Bystrica</city>
        <zip>974 04</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bratislava</city>
        <zip>821 08</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dubnica Nad Vahom</city>
        <zip>018 41</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Galanta</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krompachy</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Piestany</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Presov</city>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG7 3SQ</zip>
        <country>United Kingdom</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>
        <zip>S40 4AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poole</city>
        <state>Dorset</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>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>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>
        <zip>NN8 4RW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barnsley</city>
        <state>South Yorkshire</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>Dudley</city>
        <state>WEST Midlands</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belfast</city>
        <zip>BT7 2EB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manchester</city>
        <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>Bulgaria</country>
    <country>Estonia</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Latvia</country>
    <country>New Zealand</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>August 24, 2020</results_first_submitted>
  <results_first_submitted_qc>November 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2020</results_first_posted>
  <disposition_first_submitted>June 30, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>June 30, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 5, 2017</disposition_first_posted>
  <last_update_submitted>November 5, 2020</last_update_submitted>
  <last_update_submitted_qc>November 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
  </intervention_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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 2280 participants who met all inclusion criteria and no exclusion criteria were enrolled from 19 Nov 2014 to 07 July 2016 at 178 sites. Of the 2280 participants enrolled, 1270 participants were randomized.</recruitment_details>
      <pre_assignment_details>Eligible participants were randomized in a 1:1:1:1 ratio to either DS5565 15 mg QD, DS5565 15 mg BID, placebo, or pregabalin 150 mg BID.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
        </group>
        <group group_id="P2">
          <title>Pregabalin 150 mg BID</title>
          <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
        </group>
        <group group_id="P3">
          <title>DS-5565 15 mg QD</title>
          <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
        </group>
        <group group_id="P4">
          <title>DS-5565 15 mg BID</title>
          <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="318"/>
                <participants group_id="P2" count="317"/>
                <participants group_id="P3" count="318"/>
                <participants group_id="P4" count="317"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="249"/>
                <participants group_id="P2" count="238"/>
                <participants group_id="P3" count="241"/>
                <participants group_id="P4" count="221"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="77"/>
                <participants group_id="P4" count="96"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="42"/>
                <participants group_id="P4" count="50"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Demographics at baseline were assessed in the Randomized Analysis Set.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants take one each of placebo tablet and capsule BID)</description>
        </group>
        <group group_id="B2">
          <title>Pregabalin</title>
          <description>Participants take one pregabalin capsule and one placebo tablet BID</description>
        </group>
        <group group_id="B3">
          <title>DS-5565 QD</title>
          <description>Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening</description>
        </group>
        <group group_id="B4">
          <title>DS-5565 BID</title>
          <description>Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)</description>
        </group>
        <group group_id="B5">
          <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="318"/>
            <count group_id="B2" value="317"/>
            <count group_id="B3" value="318"/>
            <count group_id="B4" value="317"/>
            <count group_id="B5" value="1270"/>
          </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="289"/>
                    <measurement group_id="B2" value="287"/>
                    <measurement group_id="B3" value="286"/>
                    <measurement group_id="B4" value="284"/>
                    <measurement group_id="B5" value="1146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="124"/>
                  </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="50.2" spread="11.43"/>
                    <measurement group_id="B2" value="50.9" spread="11.58"/>
                    <measurement group_id="B3" value="50.2" spread="11.85"/>
                    <measurement group_id="B4" value="50.6" spread="11.46"/>
                    <measurement group_id="B5" value="50.5" spread="11.57"/>
                  </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="290"/>
                    <measurement group_id="B2" value="288"/>
                    <measurement group_id="B3" value="295"/>
                    <measurement group_id="B4" value="287"/>
                    <measurement group_id="B5" value="1160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Romania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="188"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="188"/>
                    <measurement group_id="B4" value="188"/>
                    <measurement group_id="B5" value="752"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="153"/>
                  </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="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="41"/>
                  </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="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Estonia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="39"/>
                  </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="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>ADPS was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.</description>
          <population>ADPS was assessed using the modified intent-to-treat (mITT) analysis set.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="311"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.86" spread="0.130"/>
                    <measurement group_id="O2" value="-2.47" spread="0.133"/>
                    <measurement group_id="O3" value="-2.24" spread="0.133"/>
                    <measurement group_id="O4" value="-2.09" spread="0.134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.61</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.183</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.97</ci_lower_limit>
            <ci_upper_limit>-0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0392</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.183</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.74</ci_lower_limit>
            <ci_upper_limit>-0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2192</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.183</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.58</ci_lower_limit>
            <ci_upper_limit>0.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2095</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.184</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>0.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0381</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.185</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.75</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Answered &quot;Much Improved or Better&quot; on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo</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; (≤2 scores) are reported.</description>
        <time_frame>Week 13 postdose</time_frame>
        <population>PGIC was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Answered &quot;Much Improved or Better&quot; on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo</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; (≤2 scores) are reported.</description>
          <population>PGIC was assessed using the modified intent-to-treat (mITT) 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="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="141"/>
                    <measurement group_id="O3" value="116"/>
                    <measurement group_id="O4" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome.&#xD;
For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>FIQ was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome.&#xD;
For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.</description>
          <population>FIQ was assessed using the modified intent-to-treat (mITT) 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="313"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="312"/>
                <count group_id="O4" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.88" spread="1.20"/>
                    <measurement group_id="O2" value="-21.46" spread="1.22"/>
                    <measurement group_id="O3" value="-17.41" spread="1.22"/>
                    <measurement group_id="O4" value="-16.45" spread="1.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.598</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.71</ci_lower_limit>
            <ci_upper_limit>-4.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0289</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.613</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.68</ci_lower_limit>
            <ci_upper_limit>-0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1148</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.625</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.75</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0125</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.621</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>7.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Analysis was based on multiple imputation and pattern mixture model with delta shifting.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0023</p_value>
            <method>Difference of means</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.647</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.78</ci_lower_limit>
            <ci_upper_limit>8.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.</description>
        <time_frame>Week 13 postdose</time_frame>
        <population>Responder rates were assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.</description>
          <population>Responder rates were assessed using the modified intent-to-treat (mITT) 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="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30% Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="139"/>
                    <measurement group_id="O3" value="123"/>
                    <measurement group_id="O4" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50% Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="90"/>
                    <measurement group_id="O3" value="79"/>
                    <measurement group_id="O4" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).&#xD;
For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>Multidimensional Fatigue Inventory (MFI-20) was assessed in the modified intent-to-treat (mITT) population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).&#xD;
For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.</description>
          <population>Multidimensional Fatigue Inventory (MFI-20) was assessed in the modified intent-to-treat (mITT) population.</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="293"/>
                <count group_id="O2" value="294"/>
                <count group_id="O3" value="295"/>
                <count group_id="O4" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="3.45"/>
                    <measurement group_id="O2" value="-2.8" spread="3.99"/>
                    <measurement group_id="O3" value="-2.3" spread="3.57"/>
                    <measurement group_id="O4" value="-2.1" spread="3.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0247</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.2</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0411</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>-0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0352</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0214</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>The HADS questionnaire is a reliable, widely-used 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 (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>HADS was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>The HADS questionnaire is a reliable, widely-used 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 (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).</description>
          <population>HADS was assessed using the modified intent-to-treat (mITT) 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="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to Week 13: Anxiety</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="294"/>
                    <count group_id="O3" value="295"/>
                    <count group_id="O4" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="3.43"/>
                    <measurement group_id="O2" value="-1.4" spread="3.47"/>
                    <measurement group_id="O3" value="-0.7" spread="3.30"/>
                    <measurement group_id="O4" value="-0.8" spread="3.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to Week 13: Depression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="294"/>
                    <count group_id="O3" value="295"/>
                    <count group_id="O4" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="3.66"/>
                    <measurement group_id="O2" value="-1.6" spread="3.86"/>
                    <measurement group_id="O3" value="-1.1" spread="3.78"/>
                    <measurement group_id="O4" value="-0.8" spread="3.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>-0.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5066</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1462</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0035</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.3</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Anxiety: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0338</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Depression: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0116</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Depression: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7085</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Depression: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9392</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Depression: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0311</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Depression: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0094</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo</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 scale ranges 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) scores are reported.</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>This outcome was assessed using the modified intent-to-treat analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo</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 scale ranges 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) scores are reported.</description>
          <population>This outcome was assessed using the modified intent-to-treat 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="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change from baseline to Week 13:Physical Component</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="293"/>
                    <count group_id="O3" value="295"/>
                    <count group_id="O4" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.395" spread="6.81"/>
                    <measurement group_id="O2" value="5.815" spread="8.03"/>
                    <measurement group_id="O3" value="5.000" spread="7.76"/>
                    <measurement group_id="O4" value="4.833" spread="7.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline to Week 13: Mental Component</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="293"/>
                    <count group_id="O3" value="295"/>
                    <count group_id="O4" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.371" spread="9.43"/>
                    <measurement group_id="O2" value="3.093" spread="8.93"/>
                    <measurement group_id="O3" value="1.675" spread="9.94"/>
                    <measurement group_id="O4" value="1.198" spread="8.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Component: Placebo vs Pregabalin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0373</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>1.256</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6027</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.074</ci_lower_limit>
            <ci_upper_limit>2.439</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Physical Component: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5458</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>0.364</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6020</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.817</ci_lower_limit>
            <ci_upper_limit>1.545</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Physical Component: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6968</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.235</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6038</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.949</ci_lower_limit>
            <ci_upper_limit>1.420</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Physical Component: Pregabalin vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1379</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.893</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6014</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.073</ci_lower_limit>
            <ci_upper_limit>0.287</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Physical Component: Pregabalin vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0908</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.021</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6033</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.205</ci_lower_limit>
            <ci_upper_limit>0.163</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Mental Component: Placebo vs Pregabalin</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0068</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>1.890</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6965</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.523</ci_lower_limit>
            <ci_upper_limit>3.256</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mental Component: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5594</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.406</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6956</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.959</ci_lower_limit>
            <ci_upper_limit>1.771</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Mental Component: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9736</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.023</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6979</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.346</ci_lower_limit>
            <ci_upper_limit>1.392</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mental Component: Pregabalin vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0331</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.484</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6953</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.848</ci_lower_limit>
            <ci_upper_limit>-0.119</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Mental Component: Pregabalin vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0076</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.867</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6976</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.235</ci_lower_limit>
            <ci_upper_limit>-0.498</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo</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) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome.&#xD;
For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>The EQ-5D was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo</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) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome.&#xD;
For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.</description>
          <population>The EQ-5D was assessed using the modified intent-to-treat (mITT) 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="293"/>
                <count group_id="O2" value="292"/>
                <count group_id="O3" value="295"/>
                <count group_id="O4" value="291"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.060" spread="0.18"/>
                    <measurement group_id="O2" value="0.10" spread="0.19"/>
                    <measurement group_id="O3" value="0.08" spread="0.17"/>
                    <measurement group_id="O4" value="0.07" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0201</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.0309</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01328</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0048</ci_lower_limit>
            <ci_upper_limit>0.0570</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1798</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>0.0178</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01324</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0082</ci_lower_limit>
            <ci_upper_limit>0.0438</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5922</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>0.0071</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01329</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0189</ci_lower_limit>
            <ci_upper_limit>0.0332</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3221</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.0131</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01326</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0392</ci_lower_limit>
            <ci_upper_limit>0.0129</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0739</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.0238</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.01330</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0499</ci_lower_limit>
            <ci_upper_limit>0.0023</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo</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.</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>Pain-associated sleep interference was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo</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.</description>
          <population>Pain-associated sleep interference was assessed using the modified intent-to-treat (mITT) analysis set.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.92" spread="0.11"/>
                    <measurement group_id="O2" value="-2.41" spread="0.11"/>
                    <measurement group_id="O3" value="-2.48" spread="0.11"/>
                    <measurement group_id="O4" value="-2.44" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0015</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.153</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.79</ci_lower_limit>
            <ci_upper_limit>-0.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.153</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.86</ci_lower_limit>
            <ci_upper_limit>-0.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.153</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.81</ci_lower_limit>
            <ci_upper_limit>-0.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6464</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.154</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8543</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.154</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).</description>
        <time_frame>Week 13 postdose</time_frame>
        <population>The MOS sleep scale outcome was assessed in the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).</description>
          <population>The MOS sleep scale outcome was assessed in the modified intent-to-treat (mITT) 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="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="94"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.</description>
        <time_frame>Baseline up to Week 13 postdose</time_frame>
        <population>BFI-SF was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.</description>
          <population>BFI-SF was assessed using the modified intent-to-treat (mITT) 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="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Worst pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="2.36"/>
                    <measurement group_id="O2" value="-2.6" spread="2.37"/>
                    <measurement group_id="O3" value="-2.2" spread="2.55"/>
                    <measurement group_id="O4" value="-2.1" spread="2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Least pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="2.53"/>
                    <measurement group_id="O2" value="-1.9" spread="2.37"/>
                    <measurement group_id="O3" value="-1.5" spread="2.53"/>
                    <measurement group_id="O4" value="-1.6" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="2.13"/>
                    <measurement group_id="O2" value="-2.1" spread="2.15"/>
                    <measurement group_id="O3" value="-1.8" spread="2.15"/>
                    <measurement group_id="O4" value="-1.8" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain right now</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="2.76"/>
                    <measurement group_id="O2" value="-2.8" spread="2.48"/>
                    <measurement group_id="O3" value="-2.3" spread="2.54"/>
                    <measurement group_id="O4" value="-2.2" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.59" spread="2.17"/>
                    <measurement group_id="O2" value="-2.33" spread="2.08"/>
                    <measurement group_id="O3" value="-1.96" spread="2.17"/>
                    <measurement group_id="O4" value="-1.91" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relief (%) by treatment of pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" spread="33.69"/>
                    <measurement group_id="O2" value="31.1" spread="33.15"/>
                    <measurement group_id="O3" value="24.2" spread="33.26"/>
                    <measurement group_id="O4" value="25.9" spread="35.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interference (%)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.79" spread="22.33"/>
                    <measurement group_id="O2" value="-23.76" spread="21.81"/>
                    <measurement group_id="O3" value="-19.97" spread="23.37"/>
                    <measurement group_id="O4" value="-18.35" spread="20.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General activity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="2.77"/>
                    <measurement group_id="O2" value="-2.5" spread="2.63"/>
                    <measurement group_id="O3" value="-2.1" spread="2.66"/>
                    <measurement group_id="O4" value="-2.1" spread="2.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="2.84"/>
                    <measurement group_id="O2" value="-2.2" spread="2.65"/>
                    <measurement group_id="O3" value="-1.6" spread="2.94"/>
                    <measurement group_id="O4" value="-1.6" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walking ability</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" spread="2.60"/>
                    <measurement group_id="O2" value="-2.1" spread="2.79"/>
                    <measurement group_id="O3" value="-1.8" spread="2.88"/>
                    <measurement group_id="O4" value="-1.4" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal work</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="2.65"/>
                    <measurement group_id="O2" value="-2.3" spread="2.70"/>
                    <measurement group_id="O3" value="-1.9" spread="2.77"/>
                    <measurement group_id="O4" value="-1.9" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relations with other people</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="2.92"/>
                    <measurement group_id="O2" value="-1.8" spread="2.92"/>
                    <measurement group_id="O3" value="-1.6" spread="3.12"/>
                    <measurement group_id="O4" value="-1.2" spread="2.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.9" spread="2.99"/>
                    <measurement group_id="O2" value="-3.3" spread="2.83"/>
                    <measurement group_id="O3" value="-3.1" spread="3.14"/>
                    <measurement group_id="O4" value="-3.0" spread="2.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Enjoyment of life</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="244"/>
                    <count group_id="O2" value="234"/>
                    <count group_id="O3" value="236"/>
                    <count group_id="O4" value="220"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="3.00"/>
                    <measurement group_id="O2" value="-2.4" spread="2.85"/>
                    <measurement group_id="O3" value="-1.9" spread="3.22"/>
                    <measurement group_id="O4" value="-1.7" spread="2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Worst pain: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0014</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Worst pain: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1285</p_value>
            <method>ANCOVA</method>
            <param_type>Difference of least squares means</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Worst pain: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6595</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0938</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Worst pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0061</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Least pain: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0235</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Least pain: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3652</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Least pain: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6885</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1726</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Least pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0627</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Average pain: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0026</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Average pain: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1362</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Average pain: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4344</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1264</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Average pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0260</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Pain right now: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain right now: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0597</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Pain right now: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1198</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Severity score: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.563</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1644</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.885</ci_lower_limit>
            <ci_upper_limit>-0.240</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Severity score: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1118</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.261</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1640</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.583</ci_lower_limit>
            <ci_upper_limit>0.061</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Severity score: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3870</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.142</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1646</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.465</ci_lower_limit>
            <ci_upper_limit>0.180</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0633</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.302</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1642</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.020</ci_lower_limit>
            <ci_upper_limit>0.624</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Severity score: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0108</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.420</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1647</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.097</ci_lower_limit>
            <ci_upper_limit>0.744</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Relief by treatment of pain: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0020</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>7.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.7</ci_lower_limit>
            <ci_upper_limit>12.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Relief by treatment of pain: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2188</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>3.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>7.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Relief by treatment of pain: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0991</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>4.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>8.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0611</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-4.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.2</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Relief by treatment of pain: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1489</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-3.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.2</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Interference: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-6.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.751</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.47</ci_lower_limit>
            <ci_upper_limit>-2.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Interference: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0193</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-4.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.747</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.52</ci_lower_limit>
            <ci_upper_limit>-0.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Interference: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3506</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.64</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.752</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.07</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Interference: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2660</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>1.94</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.748</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.48</ci_lower_limit>
            <ci_upper_limit>5.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Interference: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0122</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>4.40</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.754</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>7.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>General activity: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0119</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>General activity: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0659</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>General activity: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5104</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>General activity: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4934</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>General activity: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0634</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0</ci_lower_limit>
            <ci_upper_limit>0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Mood: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mood: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0837</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Mood: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2379</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Mood: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0980</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Mood: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0283</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Walking ability: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2179</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Walking ability: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6683</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Walking ability: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2247</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4198</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Walking ability: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0146</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Normal work: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0662</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Normal work: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2282</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Normal work: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7336</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5240</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Normal work: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1349</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Relations with other people: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0464</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>-0.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Relations with other people: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0975</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Relations with other people: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6088</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7341</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Relations with other people: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0125</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Sleep: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-1.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Sleep: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sleep: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0040</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>-0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5801</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>0.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Sleep: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1869</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Enjoyment of life: Placebo vs Pregabalin 150 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>-0.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Enjoyment of life: Placebo vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0271</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Enjoyment of life: Placebo vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1123</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg QD</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1183</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1</ci_lower_limit>
            <ci_upper_limit>0.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Enjoyment of life: Pregabalin 150 mg BID vs DS-5565 15 mg BID</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0299</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>0.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
        <description>Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1).</description>
        <time_frame>Week 1 to Week 13 postdose</time_frame>
        <population>Rescue medication usage was assessed using the modified intent-to-treat (mITT) analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
          </group>
          <group group_id="O2">
            <title>Pregabalin 150 mg BID</title>
            <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
          </group>
          <group group_id="O3">
            <title>DS-5565 15 mg QD</title>
            <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
          </group>
          <group group_id="O4">
            <title>DS-5565 15 mg BID</title>
            <description>Participants who received DS-5565 15 mg twice daily (BID).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo</title>
          <description>Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1).</description>
          <population>Rescue medication usage was assessed using the modified intent-to-treat (mITT) analysis set.</population>
          <units>proportion of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="315"/>
                <count group_id="O2" value="312"/>
                <count group_id="O3" value="315"/>
                <count group_id="O4" value="313"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.32"/>
                    <measurement group_id="O2" value="0.21" spread="0.31"/>
                    <measurement group_id="O3" value="0.22" spread="0.32"/>
                    <measurement group_id="O4" value="0.21" spread="0.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5578</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.015</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0249</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.063</ci_lower_limit>
            <ci_upper_limit>0.034</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7034</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.009</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0248</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.058</ci_lower_limit>
            <ci_upper_limit>0.039</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4143</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.020</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0249</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.069</ci_lower_limit>
            <ci_upper_limit>0.028</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8365</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>0.005</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0249</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.044</ci_lower_limit>
            <ci_upper_limit>0.054</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8189</p_value>
            <method>ANCOVA</method>
            <param_type>Difference in least squares means</param_type>
            <param_value>-0.006</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0249</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.055</ci_lower_limit>
            <ci_upper_limit>0.043</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) were collected from baseline up to 4 weeks after the last study drug, up to 1 year 8 months.</time_frame>
      <desc>A TEAE is any adverse event that emerges on or after the first dosing of double blind study medication and during study treatment up to 4 weeks after the last dose of double blind study medication (having been absent prior to treatment) or worsens relative to the pre-double blind treatment state.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants who received oral pregabalin placebo and DS5565 placebo twice daily (BID).</description>
        </group>
        <group group_id="E2">
          <title>Pregabalin 150 mg BID</title>
          <description>Participants who received oral pregabalin 150 mg twice daily (BID).</description>
        </group>
        <group group_id="E3">
          <title>DS-5565 15 mg QD</title>
          <description>Participants who received oral DS5565 15 mg once daily (QD).</description>
        </group>
        <group group_id="E4">
          <title>DS-5565 15 mg BID</title>
          <description>Participants who received DS-5565 15 mg twice daily (BID).</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="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </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="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lip squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Ectopic pregnancy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Mania</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </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="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Alveolitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="313"/>
              </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="206" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="299" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="290" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="242" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="28" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="313"/>
              </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="20" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="28" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="33" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="313"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="45" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="44" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="41" subjects_at_risk="313"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="315"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="312"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="315"/>
                <counts group_id="E4" subjects_affected="29" subjects_at_risk="313"/>
              </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/NCT02187159
org study id: DS5565-A-E311
secondary id: 2013-005163-10
nct id: NCT02187159
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The main objective of this trial is to compare change in weekly average daily pain score
      (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus
      placebo. Weekly ADPS is based on daily pain scores reported by the participant that best
      describes his or her worst pain over the previous 24 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to Week 13 in Average Daily Pain Score (ADPS) in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 postdose
description: The patient reported pain intensity daily (over the past 24 hours) on a scale of 0 = no pain to 10 = worst possible pain. The daily pain scores were averaged over 7 days to calculate the weekly ADPS.
measure: Number of Participants Who Answered "Much Improved or Better" on the Patient Global Impression of Change (PGIC) Scale at Week 13 in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Week 13 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" (≤2 scores) are reported.
measure: Change From Baseline to Week 13 in Fibromyalgia Index Questionnaire (FIQ) Total Score in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 postdose
description: The total FIQ score is composed of 10 items, with a maximum possible score of 100. The first item contains 11 questions related to physical functioning and are rated on a 4-point Likert-type scale, where 0 indicates 'always' and 3 indicates 'never'. The overall impact items are rated on a 0-7 scale for the number of days that the patient felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. The symptoms items are rated on visual analog scales (0-10 cm), with higher numbers indicated greater symptomatology. Final scores range from 0 (no impairment) to 10 (maximum impairment), where higher scores indicate worse outcome.
For this outcome, the change in total FIQ score from baseline is being reported. Negative values indicate improvement from baseline in impairment.
measure: Number of Responders at Week 13 Among Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Week 13 postdose
description: The number of participants with at least a 30% or 50% reduction in average daily pain score (ADPS) at Week 13 is reported.
measure: Change From Baseline to Week 13 in Multidimensional Fatigue Inventory (MFI-20) General Fatigue Score in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 postdose
description: MFI is a validated 20-item, self-reported instrument designed to measure fatigue in the following dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. The respondent is asked to mark an 'X' in 1 of 5 boxes arranged linearly where 1 is 'Yes, that is true' and 5 is 'No, that is not true.' Each subscale consists of 4 items, 2 indicative for fatigue and 2 contraindicative. For the indicative questions, a high score indicates a high fatigue level and low scores indicate a low fatigue levels. Conversely, for the contraindicative questions a high score indicates a low fatigue level and a low score indicates a high fatigue level. Overall, respondents are rated on a scale of 0 (no fatigue) to 7 (high fatigue).
For this outcome, the change from baseline in MFI-20 general fatigue subscale score is being reported. Negative values indicate an improvement in fatigue.
measure: Change From Baseline to Week 13 in Hospital Anxiety and Depression Scale (HADS) in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 postdose
description: The HADS questionnaire is a reliable, widely-used 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 (score of 0 to 3). Scores for anxiety and depression are independently summed to compute HADS-Anxiety and HADS-Depression subscale scores, with ranges from 0 (no anxiety/depression) to 21 (most severe anxiety/depression).
measure: Change From Baseline to Week 13 in Short Form 36 (SF-36) in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 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 scale ranges 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) scores are reported.
measure: Change From Baseline to Week 13 in EuroQol Five Dimensions Questionnaire (EQ-5D) in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 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) each with a scale that ranges from 0 (no problems) to 5 (extreme problems). These 5 dimensions are combined into an overall health utilities index, and a numeric rating scale (100 mm visual analog scale) that measures perception of overall health, with 0 indicating worst health and 100 representing best imaginable health. A summary index with a maximum total score of 1 can be derived from these five dimensions by conversion with a table of scores. The maximum total score of 1 indicates the best health outcome.
For this outcome, the change from baseline in total EQ-5D score is being reported. Positive values indicate an improvement in health.
measure: Change From Baseline to Week 13 in Average Daily Sleep Interference Score (ADSIS) in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 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.
measure: The Number of Participants Reporting Optimal Sleep at Week 13 on the Medical Outcomes Study (MOS) Sleep Scale in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Week 13 postdose
description: The MOS sleep scale is a 12-item questionnaire from which the following subscales were derived: sleep disturbance (4 items), quantity of sleep/optimal sleep (1 item), snoring (1 item), awakening due to shortness of breath or due to headache (1 item), sleep adequacy (2 items), and somnolence (3 items). In addition, values for sleep disturbances index (9 items), optimal sleep scale (1 item), sleep quantity scale (1 item) were determine. Most subscales range from 0 to 100, where higher scores indicate more of the concept being measured (eg., higher sleep disturbance scores indicate greater sleep disturbances).
measure: Change From Baseline to Week 13 in the Brief Pain Inventory Short Form (BPI-SF) in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Baseline up to Week 13 postdose
description: The BPI-SF measures pain severity and interference within the past 24 hours. Items are rated on an 11-point NRS from 0 to 10, where 0 indicates does not interfere and 10 indicates completely interferes. Severity score is the average of the responses to the 4 pain intensity items that assess the Worst/Least/Average pain in the last 24 hours and the Pain Right Now. The individual items being reported (using the same scale as noted above) are Severity, General Activity, Mood, Walking Ability, Normal Work, Relations With Other People, Sleep, and Enjoyment of Life. Percentage relief of treatment pain scale ranges from 100% (complete pain relief) to 0% (no pain relief) and higher percentages indicate better outcome. Interference % is the average of responses for General activity, Mood, Walking ability, Normal work, Relations with other people, Sleep, Enjoyment of life where 0% (no interference) to 100% (completely interferes) and negative (ie. lower) percentages indicate better outcomes.
measure: Proportion of Days a Rescue Medication Was Used in Participants Receiving DS-5565, Pregabalin, or Placebo
time frame: Week 1 to Week 13 postdose
description: Proportion of days with rescue medication intake during the double-blind treatment period equals number of days with rescue medication intake/(date of last study drug administration in the double-blind treatment period) - date of first study drug administration + 1).
arm group label: DS-5565 QD
arm group type: Experimental
description: Participants take one each of placebo tablet and capsule in the morning, and one DS-5565 tablet once daily (QD) with a placebo capsule in the evening
arm group label: DS-5565 BID
arm group type: Experimental
description: Participants take one DS-5565 tablet and one placebo capsule, twice daily (BID)
arm group label: Pregabalin
arm group type: Active Comparator
description: Participants take one pregabalin capsule and one placebo tablet BID
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants take one each of placebo tablet and capsule BID
intervention type: Drug
intervention name: DS-5565
description: DS-5565 15 mg tablet for oral administration
arm group label: DS-5565 BID
arm group label: DS-5565 QD
other name: mirogabalin
intervention type: Drug
intervention name: Pregabalin
description: Pregabalin 150 mg capsule for oral administration
arm group label: Pregabalin
other name: Lyrica
intervention type: Drug
intervention name: Placebo tablet
description: Placebo tablet (matching DS5565) for oral administration
arm group label: DS-5565 QD
arm group label: Placebo
arm group label: Pregabalin
other name: Placebo matching DS-5565
intervention type: Drug
intervention name: Placebo capsule
description: Placebo capsule (matching pregabalin) for oral administration
arm group label: DS-5565 BID
arm group label: DS-5565 QD
arm group label: Placebo
other name: Placebo matching pregabalin
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: Bulgaria
country: Estonia
country: Hungary
country: India
country: Latvia
country: New Zealand
country: Romania
country: Russian Federation
country: Slovakia
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
mesh term: Pregabalin
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/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 