<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/NCT01701362</url>
  </required_header>
  <id_info>
    <org_study_id>A0081279</org_study_id>
    <secondary_id>2012-003304-12</secondary_id>
    <nct_id>NCT01701362</nct_id>
  </id_info>
  <brief_title>Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain</brief_title>
  <official_title>A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer's Upjohn has merged with Mylan to form Viatris Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to investigate if pregabalin is effective in treating neuropathic&#xD;
      (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such&#xD;
      as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia&#xD;
      repair, thoracotomy, mastectomy, focal/localized burns or crush injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline Mean Pain Score</measure>
    <time_frame>Baseline</time_frame>
    <description>This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Week 15 in Weekly Mean Pain Score</measure>
    <time_frame>up to Week 15</time_frame>
    <description>This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC) at Week 15</measure>
    <time_frame>Week 15</time_frame>
    <description>A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)</measure>
    <time_frame>up to Week 15</time_frame>
    <description>This is an 11-point NRS ranging from 0 (&quot;pain does not interfere with sleep&quot;) to 10 (&quot;pain completely interferes with sleep&quot; [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.&#xD;
Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.&#xD;
&quot;Overall&quot; is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])</measure>
    <time_frame>Week 15</time_frame>
    <description>A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pain Interference Index (BPI-sf)</measure>
    <time_frame>Week 15</time_frame>
    <description>BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.&#xD;
It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).&#xD;
The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores</measure>
    <time_frame>Week 15</time_frame>
    <description>A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.</measure>
    <time_frame>Baseline</time_frame>
    <description>MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.&#xD;
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.&#xD;
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.&#xD;
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.&#xD;
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.</measure>
    <time_frame>Week 15</time_frame>
    <description>MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.&#xD;
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.&#xD;
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.&#xD;
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.&#xD;
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in MOS-SS With Optimal Sleep Status.</measure>
    <time_frame>Week 15</time_frame>
    <description>MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.</measure>
    <time_frame>Week 15</time_frame>
    <description>Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%</measure>
    <time_frame>Week 15</time_frame>
    <description>Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">542</enrollment>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>pregabalin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pregabalin</intervention_name>
    <description>capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization</description>
    <arm_group_label>pregabalin</arm_group_label>
    <other_name>Lyrica, PD-144723</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have chronic peripheral neuropathic pain present for than 6 months after&#xD;
             a traumatic or surgical event such as, for example, motor vehicle accident, fall,&#xD;
             sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy,&#xD;
             focal/localized burns or crush injury.&#xD;
&#xD;
          -  Subjects must be literate and have the ability (unaided) to understand and use the&#xD;
             interactive voice response system (IVRS), have daily access to a telephone in order to&#xD;
             complete the IVRS assessments each day, perform telephone visits and complete all&#xD;
             required assessments/forms.&#xD;
&#xD;
          -  Subjects must have sufficient post-traumatic neuropathic pain at screening and&#xD;
             baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post&#xD;
             herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome&#xD;
             (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or&#xD;
             with Complex Regional Pain Syndrome (CRPS, Type I or Type II).&#xD;
&#xD;
          -  Subjects with other pain that may confound assessment or self-evaluation of the&#xD;
             peripheral neuropathic pain.&#xD;
&#xD;
          -  Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate&#xD;
             course of therapy at doses greater than or equal to 150 mg/day, who have previously&#xD;
             participated in a pregabalin clinical trial or who have been treated with pregabalin&#xD;
             at any time during the 6 month period prior to screening.&#xD;
&#xD;
          -  Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV&#xD;
             infection; any clinically unstable cardiovascular (including a myocardial infarction&#xD;
             [heart attack] in the 3 months prior to screening), hematological, autoimmune,&#xD;
             endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3&#xD;
             months prior to screening) respiratory, or gastrointestinal disease; symptomatic&#xD;
             peripheral vascular disease including intermittent claudication; uncontrolled diabetes&#xD;
             mellitus; untreated hypothyroidism.&#xD;
&#xD;
          -  Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example,&#xD;
             schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder&#xD;
             (GAD) or major depression that is clinically stable.&#xD;
&#xD;
          -  Subjects considered at risk of suicide or self-harm based on investigator judgment&#xD;
             and/or details of a risk assessment.&#xD;
&#xD;
          -  Use of prohibited medications in the absence of appropriate washout periods.&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tennesse Valley Pain Consultants</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dedicated Clinical Research</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85395</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOPE Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Pain Center of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Pain Center of Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuromuscular Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality of Life Medical &amp; Research Centers, LLC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Rx Clinical Research</name>
      <address>
        <city>Artesia</city>
        <state>California</state>
        <zip>90701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Behavioral Research Specialists, LLC</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NervePro Medical Corp.</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical and Translational Research Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Orange County Surgical Medical Group</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center For United Research, Inc.</name>
      <address>
        <city>Lakewood</city>
        <state>California</state>
        <zip>90805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC I.D.S. Pharmacy</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samaritan Center for Medical Research</name>
      <address>
        <city>Los Gatos</city>
        <state>California</state>
        <zip>95032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North County Clinical Research</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allied Clinical Research</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Research</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research, Inc.</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Trials, Inc.</name>
      <address>
        <city>Wildomar</city>
        <state>California</state>
        <zip>92595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Clinic</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain View Clinical Research Inc.</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Clinic</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Drug Services, The George Washington University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The George Washington University Medical Center (Department of Neurology)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The George Washington University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Research Institute</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Medical Research</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Research of West Florida</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aga Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Care Family Rehab &amp; Research Center</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research in Miami, Inc.</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homestead Medical Research , Inc.</name>
      <address>
        <city>Homestead</city>
        <state>Florida</state>
        <zip>33030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMPM Research Clinic</name>
      <address>
        <city>Miami Gardens</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Marcus Research Clinic, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Pharma CR, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida International Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kendall South Medical Center, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33185</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compass Research, LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A-One Family Practice</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aba Family Medicine, LLC</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ribo Research, LLC dba Peninsula Resarch</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Pain Care of South Florida</name>
      <address>
        <city>Royal Palm Beach</city>
        <state>Florida</state>
        <zip>33411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Pain Medicine Research</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34238</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridien Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33634</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Center for Medical Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Institute for Clinical Research, LLC</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Internal Medicine, PC</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research 1 Clinical Research Network, Inc. (Administrative Office Only)</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rehabilitation Institute of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Anesthesia Associates</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas City Bone &amp; Joint Clinic</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Otri-Med Corporation</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates, Inc.</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centex Studies, Inc</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Head Pain and Neurological Institute</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medex Healthcare Research, Inc.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quality Clinical Research, Inc.</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Clinical Research, Inc.</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Biomedical Research of America</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester, Translational Pain Research</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Winston-Salem</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Ohio Neurosciences, LLC</name>
      <address>
        <city>Bellevue</city>
        <state>Ohio</state>
        <zip>44811</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wells Institute for Health Awareness</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Ohio Research Center, LLC</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert L Kalb, M.D, Inc</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cor Clinical Research, Llc</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lynn Health Science Institute</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network, Inc.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny Pain Management, P.C.</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRI Lifetree</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacorp Clinical Trials, Inc.</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TLM Medical Services, LLC</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Comprehensive Pain Management Group, LLC</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacum Biomedical Research</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Phase Research and Development</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Pain Consultants</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FutureSearch Trials of Dallas, L. P.</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abigail R. Neiman, MD, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agadadash Kuliev, MD, PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biopharma Informatic Inc. Research Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medstar Clinical Research Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ClinRx Research, LLC</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCT - Stone Oak, LLC dba Discovery Clinical Trials</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sealy Urgent Care Center and Medical Clinic</name>
      <address>
        <city>Sealy</city>
        <state>Texas</state>
        <zip>77474</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grayline Clinical Drug Trials</name>
      <address>
        <city>Wichita Falls</city>
        <state>Texas</state>
        <zip>76309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lifetree Clinical Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewis Research, Inc./Foothill Family Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>J. Lewish Research, Inc./Foothill Family Clinic South</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integrated Neurology Services , PLLC</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IntegraTrials, LLC</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Center for Pain Management LLC</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Center for Pain Management LLC</name>
      <address>
        <city>Edmonds</city>
        <state>Washington</state>
        <zip>98026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Center for Pain Management LLC</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Center for Pain Management LLC</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network (Seattle) LLC</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Puls AD</name>
      <address>
        <city>Blagoevgrad</city>
        <zip>2700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Avis Medika&quot;</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Sv.Pantaleymon&quot;</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCC Akta Medika Ltd.</name>
      <address>
        <city>Sevlievo</city>
        <zip>5400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Aleksandrovska</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DCC &quot;Sveta Anna&quot;EOOD</name>
      <address>
        <city>Sofia</city>
        <zip>1709</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aggarwal and Associates Limited</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NRK Medical Research Clinic (Adminstrative Office Only)</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6H 4P2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NRK Medical Research Clinic</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6H 4P2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Road Diagnostic Clinic and Medical Centre</name>
      <address>
        <city>Sarnia</city>
        <state>Ontario</state>
        <zip>N7T 4X3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital &quot;dr. Ivo Pedisic&quot;</name>
      <address>
        <city>Sisak</city>
        <zip>44000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glostrup Hospital</name>
      <address>
        <city>Glostrup</city>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hannover-Mitte GmbH</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für Spezielle Schmerztherapie und Palliativmedizin</name>
      <address>
        <city>Böhlen</city>
        <state>Sachsen</state>
        <zip>04564</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>medamed GmbH Studienambulanz</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>pro scientia med im MARE Klinikum</name>
      <address>
        <city>Kiel-Kronshagen</city>
        <state>Schleswig-holstein</state>
        <zip>24119</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Berlin-Mitte GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>12627</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research GmbH</name>
      <address>
        <city>Bochum</city>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research GmbH</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20253</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis für Schmerz- und Psychotherapie</name>
      <address>
        <city>Hamburg</city>
        <zip>22767</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Schwerin GmbH</name>
      <address>
        <city>Schwerin</city>
        <zip>19055</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Magyarorszag Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1036</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNO Medical Trials Kft</name>
      <address>
        <city>Budapest</city>
        <zip>1135</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz</name>
      <address>
        <city>Miskolc</city>
        <zip>3526</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej &quot;Przychodnia Morena&quot; Sp. z.o.o.</name>
      <address>
        <city>Gdansk</city>
        <zip>80-286</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;SYNEXUS POLSKA&quot; Sp. z o.o. Oddzial w Gdyni</name>
      <address>
        <city>Gdynia</city>
        <zip>81-384</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Synexus Polska&quot; Sp. z o.o. Oddzial W Katowicach</name>
      <address>
        <city>Katowice</city>
        <zip>40-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Malopolskie Centrum Medyczne S.C.</name>
      <address>
        <city>Krakow</city>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ IGNIS dr n. med. Alicja Lobinska</name>
      <address>
        <city>Swidnik</city>
        <zip>21-040</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;SYNEXUS Polska&quot; Sp. z o.o. ODDZIAL W WARSZAWIE</name>
      <address>
        <city>Warszawa</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;SYNEXUS POLSKA&quot; Sp. z o.o. Odzial we Wroclawiu</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-088</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ponce School of Medicine, CAIMED Center</name>
      <address>
        <city>Ponce</city>
        <zip>00716</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrul Medical Sana</name>
      <address>
        <city>Bucuresti</city>
        <zip>011025</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clubul Sanatatii SRL</name>
      <address>
        <city>Campulung Muscel</city>
        <zip>115100</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic de Neuropsihiatrie Craiova</name>
      <address>
        <city>Craiova</city>
        <zip>200473</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Municipal Dr. Gavril Curteanu Oradea,Sectia Neurologie I</name>
      <address>
        <city>Oradea</city>
        <zip>410154</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta Sibiu,Sectia Neurologie</name>
      <address>
        <city>Sibiu</city>
        <zip>550166</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Judetean de Urgenta Targu-Mures , Sectia Neurologie II</name>
      <address>
        <city>Targu Mures</city>
        <zip>540136</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Welkom Clinical Trial Centre</name>
      <address>
        <city>Welkom</city>
        <state>FREE State</state>
        <zip>9460</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus SA - Stanza Clinical Research Centre</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0122</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus SA - Watermeyer Clinical Research Centre</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0184</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus SA - Roodepoort Medicross Clinical Research Centre</name>
      <address>
        <city>Roodeport</city>
        <state>Gauteng</state>
        <zip>1724</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ladulaas Kliniken</name>
      <address>
        <city>Boras</city>
        <zip>506 30</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTC, Gothia Forum, Sahlgrenska Universitetssjukhus</name>
      <address>
        <city>Göteborg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Probare</name>
      <address>
        <city>Lund</city>
        <zip>222 22</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmasite</name>
      <address>
        <city>Malmö</city>
        <zip>211 52</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bragee Medect AB</name>
      <address>
        <city>Stockholm</city>
        <zip>115 26</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>South Africa</country>
    <country>Sweden</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Israel</country>
  </removed_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081279&amp;StudyName=Placebo-controlled%20safety%20and%20efficacy%20study%20of%20pregabalin%20in%20subjects%20with%20post-traumatic%20peripheral%20neuropathic%20pain</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>July 20, 2016</results_first_submitted>
  <results_first_submitted_qc>May 4, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 7, 2017</results_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>post-traumatic peripheral neuropathic pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 187 centers participated in the study in 14 countries.&#xD;
During screening, with the exception of daily pain score data that was collected to determine participants eligibility, no participants were treated with active drug and no efficacy data were collected. Only safety and no efficacy data was collected during the taper period.</recruitment_details>
      <pre_assignment_details>Participants had clinic visits at screening, randomization, and during the treatment period, and a phone contact for follow-up after the last taper dose. All the eligible participants were randomly assigned (1:1) to 15 weeks of treatment with Pregabalin or Placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Pregabalin</title>
          <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants randomized to receive placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="275"/>
                <participants group_id="P2" count="267"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>TREATED</title>
              <participants_list>
                <participants group_id="P1" count="274"/>
                <participants group_id="P2" count="265"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="211"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse events not related to study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse events related to study drug</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer willing to participate</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insufficient clinical response</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reasons other than those mentioned above</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pregabalin</title>
          <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants randomized to receive placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="274"/>
            <count group_id="B2" value="265"/>
            <count group_id="B3" value="539"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.8" spread="12.9"/>
                    <measurement group_id="B2" value="53.4" spread="12.7"/>
                    <measurement group_id="B3" value="53.1" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18 - 44 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 - 64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="102"/>
                  </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="132"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="266"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="142"/>
                    <measurement group_id="B2" value="131"/>
                    <measurement group_id="B3" value="273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline Mean Pain Score</title>
        <description>This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.</description>
        <time_frame>Baseline</time_frame>
        <population>Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Mean Pain Score</title>
          <description>This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.</description>
          <population>Intent to Treat (ITT) population: all randomized participants who took at least one dose of study drug</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="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.41" spread="1.30"/>
                    <measurement group_id="O2" value="6.54" spread="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 15 in Weekly Mean Pain Score</title>
        <description>This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.</description>
        <time_frame>up to Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 15 in Weekly Mean Pain Score</title>
          <description>This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 (&quot;no pain&quot;) to 10 (&quot;worst possible pain&quot;). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</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="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.12" spread="0.15"/>
                    <measurement group_id="O2" value="-1.90" spread="0.16"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.1823</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Mixed Model Repeated Measures = MMRM</method_desc>
            <param_type>least squares mean difference</param_type>
            <param_value>-0.22</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.54</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
            <estimate_desc>MMRM analysis includes fixed categorical effects of treatment, country, trauma type, visit week, treatment-by-visit interaction, and fixed continuous effect of baseline value. Missing mean pain scores imputed by multiple imputation method</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGIC) at Week 15</title>
        <description>A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGIC) at Week 15</title>
          <description>A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="258"/>
                <count group_id="O2" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Very much improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimally improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimally worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Much worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very much worse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.0012</p_value>
            <p_value_desc>The p-value is derived from CMH test, stratified for pooled center and trauma type and excludes missing values.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)</title>
        <description>This is an 11-point NRS ranging from 0 (&quot;pain does not interfere with sleep&quot;) to 10 (&quot;pain completely interferes with sleep&quot; [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.&#xD;
Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.&#xD;
&quot;Overall&quot; is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.</description>
        <time_frame>up to Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)</title>
          <description>This is an 11-point NRS ranging from 0 (&quot;pain does not interfere with sleep&quot;) to 10 (&quot;pain completely interferes with sleep&quot; [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.&#xD;
Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.&#xD;
&quot;Overall&quot; is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</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="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (raw scores) (N = 274, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.97" spread="2.30"/>
                    <measurement group_id="O2" value="4.99" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (N = 260, 258)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="1.10"/>
                    <measurement group_id="O2" value="-0.28" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (N = 254, 244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.15" spread="1.51"/>
                    <measurement group_id="O2" value="-0.81" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (N = 252, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.55" spread="1.73"/>
                    <measurement group_id="O2" value="-1.14" spread="1.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (N = 245, 229)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.73" spread="1.80"/>
                    <measurement group_id="O2" value="-1.30" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 (N = 241, 226)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.87" spread="1.87"/>
                    <measurement group_id="O2" value="-1.40" spread="1.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (N = 244, 227)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.94" spread="1.95"/>
                    <measurement group_id="O2" value="-1.46" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 (N = 240, 216)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.01" spread="1.99"/>
                    <measurement group_id="O2" value="-1.50" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (N = 236, 212)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.05" spread="2.00"/>
                    <measurement group_id="O2" value="-1.52" spread="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 (N = 232, 214)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.09" spread="1.99"/>
                    <measurement group_id="O2" value="-1.55" spread="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (N = 229, 212)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.04" spread="2.11"/>
                    <measurement group_id="O2" value="-1.55" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 (N = 230, 211)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.09" spread="2.05"/>
                    <measurement group_id="O2" value="-1.64" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (N = 227, 209)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.17" spread="2.06"/>
                    <measurement group_id="O2" value="-1.68" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 (N = 225, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.19" spread="2.06"/>
                    <measurement group_id="O2" value="-1.70" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14 (N = 222, 208)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.19" spread="2.16"/>
                    <measurement group_id="O2" value="-1.79" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 (N = 196, 186)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.13" spread="2.17"/>
                    <measurement group_id="O2" value="-1.83" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall (N = 269, 262)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.83" spread="1.93"/>
                    <measurement group_id="O2" value="-1.37" spread="1.71"/>
                  </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>Week 1</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0119</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.62</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 2</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0135</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.62</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 3</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0028</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.42</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.69</ci_lower_limit>
            <ci_upper_limit>-0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 4</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0016</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.72</ci_lower_limit>
            <ci_upper_limit>-0.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 5</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>-0.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>-0.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 7</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>-0.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 8</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0003</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.79</ci_lower_limit>
            <ci_upper_limit>-0.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 9</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.82</ci_lower_limit>
            <ci_upper_limit>-0.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 10</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.77</ci_lower_limit>
            <ci_upper_limit>-0.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 11</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>-0.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.82</ci_lower_limit>
            <ci_upper_limit>-0.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 13</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.84</ci_lower_limit>
            <ci_upper_limit>-0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 14</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.78</ci_lower_limit>
            <ci_upper_limit>-0.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 15</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0031</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.71</ci_lower_limit>
            <ci_upper_limit>-0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Mixed Model Repeated Measures Analysis</method>
            <method_desc>Analyzed for treatment, center, trauma type, week &amp; treatment-by-week interaction and fixed continuous effect of baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.71</ci_lower_limit>
            <ci_upper_limit>-0.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])</title>
        <description>A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])</title>
          <description>A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</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="258"/>
                <count group_id="O2" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.40" spread="0.13" lower_limit="-8.3" upper_limit="2.5"/>
                    <measurement group_id="O2" value="-1.95" spread="0.13" lower_limit="-6.5" upper_limit="2.5"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.0050</p_value>
            <method>ANCOVA</method>
            <method_desc>This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least squares mean difference</param_type>
            <param_value>-0.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.77</ci_lower_limit>
            <ci_upper_limit>-0.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pain Interference Index (BPI-sf)</title>
        <description>BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.&#xD;
It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).&#xD;
The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pain Interference Index (BPI-sf)</title>
          <description>BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.&#xD;
It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).&#xD;
The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</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="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.72" spread="0.13" lower_limit="-1.97" upper_limit="-1.46"/>
                    <measurement group_id="O2" value="-1.33" spread="0.13" lower_limit="-1.59" upper_limit="-1.07"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.0168</p_value>
            <method>ANCOVA</method>
            <method_desc>This secondary endpoint has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <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>0.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.70</ci_lower_limit>
            <ci_upper_limit>-0.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores</title>
        <description>A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores</title>
          <description>A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</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="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobility</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.03" lower_limit="-0.16" upper_limit="-0.05"/>
                    <measurement group_id="O2" value="-0.09" spread="0.03" lower_limit="-0.15" upper_limit="-0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-care</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.02" lower_limit="-0.12" upper_limit="0.04"/>
                    <measurement group_id="O2" value="-0.06" spread="0.02" lower_limit="-0.11" upper_limit="-0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Usual activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="0.03" lower_limit="-0.19" upper_limit="-0.05"/>
                    <measurement group_id="O2" value="-0.13" spread="0.04" lower_limit="-0.20" upper_limit="-0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain/Discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.35" spread="0.03" lower_limit="-0.42" upper_limit="-0.28"/>
                    <measurement group_id="O2" value="-0.29" spread="0.04" lower_limit="-0.36" upper_limit="-0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety/Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.03" lower_limit="-0.05" upper_limit="0.07"/>
                    <measurement group_id="O2" value="-0.02" spread="0.03" lower_limit="-0.08" upper_limit="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dolan 1997 Index Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.01"/>
                    <measurement group_id="O2" value="0.11" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dolan 2001 Index Score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.02"/>
                    <measurement group_id="O2" value="-0.12" spread="0.02"/>
                  </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>This statistical analysis is for mobility</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.6841</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least squares mean difference</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.037</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This statistical analysis is for self-care</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.6564</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least squares mean difference</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.029</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This statistical analysis is for usual activities</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.8590</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least squares mean difference</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.043</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.08</ci_lower_limit>
            <ci_upper_limit>0.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This statistical analysis is for pain/discomfort</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1628</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least squares mean difference</param_type>
            <param_value>-0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.043</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.14</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This statistical analysis is for anxiety/depression</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.4654</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>leaset squares mean difference</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.037</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This statistical analysis is for Dolan 1997 Index score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.5000</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least squares mean difference</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.017</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This statistical analysis is for Dolan 2001 Index Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.5493</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>leaset squares mean difference</param_type>
            <param_value>-0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.026</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>0.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.</title>
        <description>MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.&#xD;
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.&#xD;
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.&#xD;
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.&#xD;
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.</description>
        <time_frame>Baseline</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.</title>
          <description>MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.&#xD;
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.&#xD;
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.&#xD;
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.&#xD;
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug.</population>
          <units>Units on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sleep Disturbance Score (N = 274, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.50" spread="25.791" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="43.75" spread="25.080" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep Adequancy Score (N = 274, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" spread="28.153" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="40.0" spread="28.582" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Snoring Score (N = 272, 263)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" spread="33.482" lower_limit="0" upper_limit="100"/>
                    <measurement group_id="O2" value="20.0" spread="34.084" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awaken Short of Breath Score (N = 274, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="25.647" lower_limit="0.0" upper_limit="100"/>
                    <measurement group_id="O2" value="0.0" spread="21.541" lower_limit="0.0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Quantity of Sleep Score (hours) (N = 273, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="1.360" lower_limit="2.0" upper_limit="10.0"/>
                    <measurement group_id="O2" value="6.0" spread="1.411" lower_limit="2.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somnolence Score (N = 274, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.67" spread="21.618" lower_limit="0.0" upper_limit="100"/>
                    <measurement group_id="O2" value="26.67" spread="19.884" lower_limit="0.0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep Problem Index (9) Score (N = 274, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.56" spread="20.282" lower_limit="0.0" upper_limit="88.3"/>
                    <measurement group_id="O2" value="41.11" spread="19.720" lower_limit="0.0" upper_limit="88.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimal Sleep Score (N = 273, 265)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="0.476" lower_limit="0.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0.0" spread="0.487" lower_limit="0.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.</title>
        <description>MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.&#xD;
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.&#xD;
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.&#xD;
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.&#xD;
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.</title>
          <description>MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.&#xD;
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.&#xD;
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.&#xD;
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.&#xD;
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sleep Disturbance Score (N = 257, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.71" lower_limit="-17.57" upper_limit="-11.85"/>
                    <measurement group_id="O2" value="-11.24" lower_limit="-14.16" upper_limit="-8.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep Adequancy Score (N=257, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.13" lower_limit="6.49" upper_limit="13.76"/>
                    <measurement group_id="O2" value="8.16" lower_limit="4.43" upper_limit="11.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Snoring Score (N = 257, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.22" lower_limit="-5.46" upper_limit="1.03"/>
                    <measurement group_id="O2" value="-3.27" lower_limit="-6.59" upper_limit="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awaken Short of Breath Score (N = 257, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.61" lower_limit="-6.30" upper_limit="-0.92"/>
                    <measurement group_id="O2" value="-3.03" lower_limit="-5.78" upper_limit="-0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Quantity of Sleep Score (hours) (N = 257, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" lower_limit="0.19" upper_limit="0.66"/>
                    <measurement group_id="O2" value="0.26" lower_limit="0.03" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somnolence Score (N = 257, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.61" lower_limit="-3.99" upper_limit="0.77"/>
                    <measurement group_id="O2" value="-3.74" lower_limit="-6.17" upper_limit="-1.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleep Problem Index (9) Score (N = 257, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.86" lower_limit="-12.17" upper_limit="-7.56"/>
                    <measurement group_id="O2" value="-8.19" lower_limit="-10.55" upper_limit="-5.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Optimal Sleep Score (N = 256, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" lower_limit="0.05" upper_limit="0.18"/>
                    <measurement group_id="O2" value="0.04" lower_limit="-0.03" upper_limit="0.10"/>
                  </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>Statistical analysis for Sleep Disturbance Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0545</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>3.5</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>7.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Sleep Adequancy Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.3913</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-2.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-6.47</ci_lower_limit>
            <ci_upper_limit>2.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Snoring Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.6059</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-5.06</ci_lower_limit>
            <ci_upper_limit>2.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Awaken Short of Breath Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.7317</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>0.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-2.76</ci_lower_limit>
            <ci_upper_limit>3.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Quantity of Sleep Score (hours)</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.2663</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.45</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Somnolence Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1562</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>-2.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.50</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-5.08</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Sleep Problem Index (9) Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.2490</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>least square mean difference</param_type>
            <param_value>1.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-1.18</ci_lower_limit>
            <ci_upper_limit>4.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis for Optimal Sleep Score</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0609</p_value>
            <method>ANCOVA</method>
            <method_desc>This sub-score has been analyzed using ANCOVA with model terms of treatment, center, trauma type and baseline value on the ITT population.</method_desc>
            <param_type>leaet squares mean difference</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in MOS-SS With Optimal Sleep Status.</title>
        <description>MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized subjects who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in MOS-SS With Optimal Sleep Status.</title>
          <description>MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.</description>
          <population>ITT population: all randomized subjects who took at least one dose of study drug</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Improvements</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.2"/>
                    <measurement group_id="O2" value="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.1"/>
                    <measurement group_id="O2" value="60.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Worsening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2"/>
                    <measurement group_id="O2" value="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="7.5"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>0.7165</p_value>
            <p_value_desc>p-values based on CMH test stratified by pooled center and trauma type, patients with unknown status at baseline or endpoint will not be included in the calculation of p-values.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.</title>
        <description>Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.</title>
          <description>Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (N = 260, 258)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.92"/>
                    <measurement group_id="O2" value="5.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (N = 254, 244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.17"/>
                    <measurement group_id="O2" value="20.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (N = 252, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.89"/>
                    <measurement group_id="O2" value="30.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (N = 246, 229)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.87"/>
                    <measurement group_id="O2" value="34.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 (N = 241, 226)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.64"/>
                    <measurement group_id="O2" value="38.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (N = 244, 227)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.77"/>
                    <measurement group_id="O2" value="41.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 (N = 240, 216)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.58"/>
                    <measurement group_id="O2" value="43.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (N = 236, 213)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.42"/>
                    <measurement group_id="O2" value="46.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 (N = 232, 214)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.86"/>
                    <measurement group_id="O2" value="47.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (N = 229, 212)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.84"/>
                    <measurement group_id="O2" value="47.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 (N = 231, 211)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.38"/>
                    <measurement group_id="O2" value="51.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (N = 227, 209)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.63"/>
                    <measurement group_id="O2" value="52.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 (N = 226, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.08"/>
                    <measurement group_id="O2" value="54.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14 (N = 223, 208)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.40"/>
                    <measurement group_id="O2" value="54.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 (N = 196, 187)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.65"/>
                    <measurement group_id="O2" value="58.29"/>
                  </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>Statistical analysis at Week 1</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0028</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.50</ci_lower_limit>
            <ci_upper_limit>6.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 2</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0360</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>2.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 3</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0235</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>2.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 4</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0619</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>2.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 5</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0677</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0707</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>2.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 7</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1313</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>2.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 8</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.3072</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.82</ci_lower_limit>
            <ci_upper_limit>1.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 9</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.3947</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 10</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1462</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>2.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 11</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.6854</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>1.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.5025</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.15</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 13</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.4908</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 14</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.4245</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.19</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 15</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.8464</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%</title>
        <description>Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.</description>
        <time_frame>Week 15</time_frame>
        <population>ITT population: all randomized participants who took at least one dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Pregabalin</title>
            <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants randomized to receive placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%</title>
          <description>Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.</description>
          <population>ITT population: all randomized participants who took at least one dose of study drug</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (N = 260, 258)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.62"/>
                    <measurement group_id="O2" value="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (N = 254, 244)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.42"/>
                    <measurement group_id="O2" value="6.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (N = 252, 245)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.62"/>
                    <measurement group_id="O2" value="13.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (N = 246, 229)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.20"/>
                    <measurement group_id="O2" value="17.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5 (N = 241, 226)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.22"/>
                    <measurement group_id="O2" value="19.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6 (N = 244, 227)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.51"/>
                    <measurement group_id="O2" value="22.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7 (N= 240, 216)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.42"/>
                    <measurement group_id="O2" value="22.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 (N = 236, 213)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.05"/>
                    <measurement group_id="O2" value="27.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9 (N = 232, 214)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.05"/>
                    <measurement group_id="O2" value="26.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10 (N = 229, 212)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.75"/>
                    <measurement group_id="O2" value="26.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11 (N = 231, 211)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.20"/>
                    <measurement group_id="O2" value="25.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 (N = 227, 209)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.89"/>
                    <measurement group_id="O2" value="26.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13 (N = 226, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.84"/>
                    <measurement group_id="O2" value="27.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14 (N = 223, 208)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.67"/>
                    <measurement group_id="O2" value="29.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 15 (N = 196, 187)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.80"/>
                    <measurement group_id="O2" value="34.22"/>
                  </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>Statistical analysis at Week 1</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1633</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>6.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 2</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0652</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>3.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 3</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0039</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.29</ci_lower_limit>
            <ci_upper_limit>3.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 4</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0382</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>2.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 5</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0137</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.14</ci_lower_limit>
            <ci_upper_limit>3.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 6</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0693</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>2.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 7</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0349</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.04</ci_lower_limit>
            <ci_upper_limit>2.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 8</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1227</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.44</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>2.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 9</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0364</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.03</ci_lower_limit>
            <ci_upper_limit>2.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 10</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0667</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>2.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 11</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0176</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.10</ci_lower_limit>
            <ci_upper_limit>2.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 12</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0030</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.27</ci_lower_limit>
            <ci_upper_limit>3.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 13</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0256</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.07</ci_lower_limit>
            <ci_upper_limit>2.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 14</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.0314</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>1.05</ci_lower_limit>
            <ci_upper_limit>2.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Statistical analysis at Week 15</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.1889</p_value>
            <method>Gen linear model-logistic link function</method>
            <method_desc>Model terms include categorical: treatment, center, trauma type, week, and treatment-by-week interaction; and continuous: baselines mean pain score.</method_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>2.21</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day -21 to Day 112 (week 16) i.e. from baseline until 1 day post last taper dose.</time_frame>
      <desc>The adverse events reporting period was from the signing of the informed consent (at screening) throughout the study including 28 calendar days from the last dose of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Pregabalin</title>
          <description>Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants randomized to receive placebo</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
              <event>
                <sub_title>Post procedural discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 18.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="274"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="274"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="274"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="265"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="51" subjects_affected="40" subjects_at_risk="274"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="265"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="31" subjects_affected="27" subjects_at_risk="274"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="265"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer Clinical Trials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT01701362
org study id: A0081279
secondary id: 2012-003304-12
nct id: NCT01701362
lead sponsor: 
has dmc: Yes
This study is designed to investigate if pregabalin is effective in treating neuropathic
      (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such
      as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia
      repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Baseline Mean Pain Score
time frame: Baseline
description: This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
measure: Change From Baseline to Week 15 in Weekly Mean Pain Score
time frame: up to Week 15
description: This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
measure: Patient Global Impression of Change (PGIC) at Week 15
time frame: Week 15
description: A self administered instrument that measures changes in participants' overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). The PGIC is based on the Clinical Global Impression of Change, which is a validated scale.
measure: Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)
time frame: up to Week 15
description: This is an 11-point NRS ranging from 0 ("pain does not interfere with sleep") to 10 ("pain completely interferes with sleep" [unable to sleep due to pain]). Participants describe how pain has interfered with their sleep during the past 24 hours. Please note that the data for Baseline (raw scores) have been included in the below table to read the change from Baseline data in context.
Note: Weekly mean SIRS scores were derived from the daily sleep diary and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean SIRS scores were defined as the mean of the 7 daily diary SIRS scores from Day 2+7 (n-1) to Day 1+7*n. For participants with multiple diary scores collected on the same day, the average of all non-missing scores for that day was used in any analyses or data listings.
"Overall" is the pooled average sleep interference score for each subject across all post-baseline/randomization weeks.
measure: Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])
time frame: Week 15
description: A self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation. The BPI-sf consists of 5 questions. Four items measure pain on 11-point response scales from 0 (No Pain) to 10 (Pain as bad as you can imagine). In the above scale, score 0 indicates the better outcome whereas score 10 indicates the worse outcome.
measure: Change From Baseline in Pain Interference Index (BPI-sf)
time frame: Week 15
description: BPI-sf is a self-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24 hour period prior to evaluation.
It consists of 7 sub-questions that evaluates the level of pain interference with daily functioning on 11-point response scales from 0 (does not interfere) to 10 (completely interferes).
The BPI-sf pain interference index was calculated as average of the seven individual pain interference scores.
measure: Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores
time frame: Week 15
description: A self-administered questionnaire designed to assess health related quality of life in terms of a single index value or utility score. There are 5 dimensions: mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression. Each dimension is rated on a 3 point response scale and the scores are combined to form a single index value between 0 and 1 with higher scores being more positive (better health status). The EQ-5D was completed by the subject at week-0 and week-15/ET where 30% responder and 50% responder status would be defined for each participants based on the percent change from baseline (week 0/Randomization) to each visit week in mean pain score and participant global impression of change (PGIC). PGIC is a self-administered instrument that measures change in participant's overall status on a scale ranging from 1 (very much improved) to 7 (very much worse). It is based on the Clinical Global Impression of Change CGIC), which is a validated scale.
measure: Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
time frame: Baseline
description: MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.
measure: Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.
time frame: Week 15
description: MOS-SS is a self administered measure consisting of twelve items that assess the key constructs of sleep. Instrument scored results in 7 subscales: sleep disturbance, snoring, awaken short of breath or with headache, quantity of sleep, optimal sleep, sleep adequacy, somnolence. Two index measures that assess sleep disturbance was also constructed to provide composite scores.
Sleep disturbance, snoring, somnolence, awaken short of breath, and the 9 items sleep problems index all have score ranges from 0 (no sleep problems) to 100 (greater sleep problems), therefore a negative change indicates improvement.
Sleep adequacy is scored 0 (least sleep adequacy) to 100 (better sleep adequacy), therefore a positive change indicates improvement.
Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), therefore a positive change indicates improvement.
Optimal sleep is scored Yes if average hours of sleep is in range of 7-8 hours.
measure: Percentage of Participants in MOS-SS With Optimal Sleep Status.
time frame: Week 15
description: MOS-SS optimal sleep status analyzed on a scale of four parameters: any improvements, no change, any worsening and not applicable.
measure: Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.
time frame: Week 15
description: Participants with at least 30% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
measure: Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%
time frame: Week 15
description: Participants with at least 50% reduction in the mean pain score from baseline to each week. Weekly mean pain NRS scores are derived from the daily pain NRS and calculated as the mean of the available scores in the 7 days. Generally, week 'n' mean pain score is defined as the mean of the 7 daily diary pain ratings from Day 2+7*(n-1) to Day 1+7*n. At least 4 entries within the last 7 days are required to calculate a mean score. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scored indicating increased pain.
arm group label: pregabalin
arm group type: Active Comparator
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: pregabalin
description: capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
arm group label: pregabalin
other name: Lyrica, PD-144723
intervention type: Drug
intervention name: placebo
description: capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Bulgaria
country: Canada
country: Croatia
country: Denmark
country: Germany
country: Hungary
country: Korea, Republic of
country: Poland
country: Puerto Rico
country: Romania
country: South Africa
country: Sweden
country: United States
country: Israel
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081279&StudyName=Placebo-controlled%20safety%20and%20efficacy%20study%20of%20pregabalin%20in%20subjects%20with%20post-traumatic%20peripheral%20neuropathic%20pain
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Neuralgia
mesh term: Pregabalin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 