<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/NCT02262754</url>
  </required_header>
  <id_info>
    <org_study_id>B7431006</org_study_id>
    <nct_id>NCT02262754</nct_id>
  </id_info>
  <brief_title>PF-06372865 In Subjects With Chronic Low Back Pain</brief_title>
  <official_title>A Randomized, Double Blind, Placebo- And Active-controlled, 4 Week, Multi-center, Parallel Group Study Assessing The Analgesic Effect, Safety And Tolerability Of Pf-06372865 In Subjects With Chronic Low Back Pain Using Naproxen As Positive Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PF-06372865 In Subjects With Chronic Low Back Pain&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 28 days after the last dose of study treatment (Day 56)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Baseline up to 28 days after the last dose of study treatment (Day 56)</time_frame>
    <description>Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [&lt;] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (&lt;0.6*LLN, greater than [&gt;] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (&lt;0.9*LLN, &gt;1.1*ULN); platelets (&lt;0.5*LLN&gt;, &gt;1.75*ULN); neutrophils, lymphocytes(&lt;0.8*LLN, &gt;1.2*ULN); eosinophils, basophils, monocytes (&gt;1.2*ULN); total bilirubin (&gt;1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (&gt;3*ULN); total protein, albumin (&lt;0.8*LLN, &gt;1.2*ULN); creatinine, blood urea nitrogen (&gt;1.3*ULN); glucose (&lt;0.6*LLN, &gt;1.5*ULN); uric acid (&gt;1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (&lt;0.9*LLN, &gt;1.1*ULN); urine pH (&lt;4.5, &gt;8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [&gt;=] 1) in urine dipstick test; urine RBC, WBC (&gt;=20); hyaline casts (&gt;1), bacteria (&gt;20).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Vital Sign Abnormalities</measure>
    <time_frame>Baseline up to Follow-up (44 days)</time_frame>
    <description>Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) &lt;90 millimeter of mercury (mmHg), supine diastolic BP (DBP) &lt;50 mmHg, supine pulse rate &lt;40 beats per minute (bpm) or &gt;120 bpm. Maximum increase or decrease from baseline in supine SBP &gt;=30 mmHg and maximum increase or decrease from baseline in supine DBP &gt;=20 mmHg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Electrocardiogram (ECG) Abnormalities</measure>
    <time_frame>Baseline up to Follow-up (44 days)</time_frame>
    <description>Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of &gt;=300 milliseconds (msec), maximum QRS interval &gt;=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to &lt;480 msec, 480 to &lt;500 msec and &gt;=500 msec, maximum of &gt;=25 percent (%) increase from baseline (IFB) value of &gt;200 msec and &gt;=50% for baseline value of less than or equal to (&lt;=) 200 msec for PR interval, maximum increase from baseline of &gt;=50% for QRS interval, maximum increase from baseline of &gt;=30 msec to &lt;60 msec and maximum increase from baseline of &gt;60 msec in QTCF interval (Fridericia's Correction).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Screening, Baseline, Week 1, 2, 3, 4</time_frame>
    <description>The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of &quot;Yes&quot; on &quot;actual attempt&quot;), preparatory acts toward imminent suicidal behavior =3 (&quot;Yes&quot; on &quot;preparatory acts or behavior&quot;), suicidal ideation =4 (&quot;Yes&quot; on &quot;wish to be dead&quot;, &quot;non-specific active suicidal thoughts&quot;, &quot;active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 (&quot;Yes&quot; on &quot;Has participant engaged in non-suicidal self-injurious behavior&quot;).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit</measure>
    <time_frame>End of treatment (Day 30), follow-up (Day 44)</time_frame>
    <description>PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4</measure>
    <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
    <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4</measure>
    <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
    <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (&gt;=) 30 Percent and &gt;=50 Percent Reduction From Baseline</measure>
    <time_frame>Baseline up to Week 4</time_frame>
    <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at &gt;=30 percent and &gt;=50 percent reduced from baseline were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Withdrawn Due to Lack of Efficacy</measure>
    <time_frame>Baseline up to Week 4</time_frame>
    <description>Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Withdrawal Due to Lack of Efficacy</measure>
    <time_frame>Baseline up to Week 4</time_frame>
    <description>Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as &quot;Insufficient Clinical Response&quot;. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Using Rescue Medication</measure>
    <time_frame>Week 1, 2, 3, 4</time_frame>
    <description>Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Participants Used the Rescue Medication</measure>
    <time_frame>Week 1, 2, 3, 4</time_frame>
    <description>The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Rescue Medication Used by the Participants</measure>
    <time_frame>Week 1, 2, 3, 4</time_frame>
    <description>The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3</measure>
    <time_frame>Baseline, Week 1, 2, 3</time_frame>
    <description>Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4</measure>
    <time_frame>Baseline, Week 2, Week 4</time_frame>
    <description>This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic Low Back Pain (CLBP) Responder Index Analysis</measure>
    <time_frame>Week 1, 2, 3, 4</time_frame>
    <description>Participants were successful responders if they had any of the following: &gt;=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of &gt;=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4</measure>
    <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
    <description>Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGI-C) Score</measure>
    <time_frame>Week 1, 2, 3, 4</time_frame>
    <description>PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4</measure>
    <time_frame>Week 4</time_frame>
    <description>Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of PF-06372865</measure>
    <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
    <description>Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was &lt;0.0100 nanogram per milliliter (ng/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentration of Naproxen</measure>
    <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
    <description>Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was &lt;1000 ng/mL.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Chronic Low Back Pain</condition>
  <arm_group>
    <arm_group_label>PF-06372865</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily BID dosing for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Daily BID dosing for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Naproxen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Daily BID dosing for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06372865</intervention_name>
    <description>Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks</description>
    <arm_group_label>PF-06372865</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for PF-06372865 and placebo for naproxen daily</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naproxen</intervention_name>
    <description>500 mg BID for 4 weeks</description>
    <arm_group_label>Naproxen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</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>Agave Clinical Research, LLC</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Research Center, Inc.</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Research</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neuro-Pain Medical Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Clinical Research</name>
      <address>
        <city>North Hollywood</city>
        <state>California</state>
        <zip>91606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Trials, Incorporate</name>
      <address>
        <city>Wildomar</city>
        <state>California</state>
        <zip>92595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stamford Therapeutics Consortium</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S&amp;W Clinical Research</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Network, LLC</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward Research Group</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</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>Pines Clinical Research Inc.</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accord Clinical Research, LLC</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arthritis &amp; Rheumatic Care Center</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Research Associates</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Better Health Clinical Research, Inc.</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30344</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>River Birch Research Alliance, LLC</name>
      <address>
        <city>Blue Ridge</city>
        <state>Georgia</state>
        <zip>30513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Medicine center</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31901</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>Drug Studies America</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Better Health Clinical Research, Inc./Georgia Pain &amp; Spine Care, Inc.</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Better Health Clinical Research, Inc.</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Regional Research Group</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Georgia Clinical Research</name>
      <address>
        <city>Woodstock</city>
        <state>Georgia</state>
        <zip>30189</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Georgia Internal medicine</name>
      <address>
        <city>Woodstock</city>
        <state>Georgia</state>
        <zip>30189</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>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>Boston Clinical Trials</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ActivMed Practices &amp; Research, Inc.</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRC of Jackson</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physician's Surgery Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trials America</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AAIR Research Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Internal Medicine Consultants, Inc.</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Research Network (Oregon), Inc.</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altoona Center for Clinical Research</name>
      <address>
        <city>Duncansville</city>
        <state>Pennsylvania</state>
        <zip>16635</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trial Network</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lee Medical Associates, PA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Clinical Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Clinical Research - Norfolk, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</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_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7431006&amp;StudyName=A%20Randomized%2C%20Double%20Blind%2C%20Placebo-%20And%20Active-controlled%2C%204%20Week%2C%20Multi-center%2C%20Parallel%20Group%20Study%20Assessing%20The%20Analgesic%20Effect%2C%20Safety%20And%20Tolerability%20Of%20Pf-06372865%20In%20Subjects%20With%20Chronic%20Low%20Back%20Pain%20Using%20Naproxen%20As%20Positive%20Control</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 9, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>July 22, 2016</results_first_submitted>
  <results_first_submitted_qc>November 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 4, 2017</results_first_posted>
  <last_update_submitted>November 4, 2016</last_update_submitted>
  <last_update_submitted_qc>November 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Low Back Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naproxen</mesh_term>
    <mesh_term>PF-06372865</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
        </group>
        <group group_id="P2">
          <title>PF-06372865</title>
          <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
        </group>
        <group group_id="P3">
          <title>Naproxen</title>
          <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets eligibility criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS) included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
        </group>
        <group group_id="B2">
          <title>PF-06372865</title>
          <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
        </group>
        <group group_id="B3">
          <title>Naproxen</title>
          <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="74"/>
            <count group_id="B2" value="74"/>
            <count group_id="B3" value="74"/>
            <count group_id="B4" value="222"/>
          </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="51.1" spread="12.1"/>
                    <measurement group_id="B2" value="49.7" spread="13.8"/>
                    <measurement group_id="B3" value="51.6" spread="13.1"/>
                    <measurement group_id="B4" value="50.8" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="38"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MALE</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4</title>
        <description>Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4</title>
          <description>Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.19" spread="1.351" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="-1.03" spread="1.091" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="-1.45" spread="1.401" lower_limit="-1.77" upper_limit="-1.14"/>
                  </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>An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.16</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.28</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (PF-06372865-Naproxen)</param_type>
            <param_value>0.42</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.26</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.70</ci_lower_limit>
            <ci_upper_limit>0.18</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.</description>
        <time_frame>Baseline up to 28 days after the last dose of study treatment (Day 56)</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="1.351" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="34" spread="1.091" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="28" spread="1.401" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [&lt;] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (&lt;0.6*LLN, greater than [&gt;] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (&lt;0.9*LLN, &gt;1.1*ULN); platelets (&lt;0.5*LLN&gt;, &gt;1.75*ULN); neutrophils, lymphocytes(&lt;0.8*LLN, &gt;1.2*ULN); eosinophils, basophils, monocytes (&gt;1.2*ULN); total bilirubin (&gt;1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (&gt;3*ULN); total protein, albumin (&lt;0.8*LLN, &gt;1.2*ULN); creatinine, blood urea nitrogen (&gt;1.3*ULN); glucose (&lt;0.6*LLN, &gt;1.5*ULN); uric acid (&gt;1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (&lt;0.9*LLN, &gt;1.1*ULN); urine pH (&lt;4.5, &gt;8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [&gt;=] 1) in urine dipstick test; urine RBC, WBC (&gt;=20); hyaline casts (&gt;1), bacteria (&gt;20).</description>
        <time_frame>Baseline up to 28 days after the last dose of study treatment (Day 56)</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study treatment. Here, &quot;number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [&lt;] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (&lt;0.6*LLN, greater than [&gt;] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (&lt;0.9*LLN, &gt;1.1*ULN); platelets (&lt;0.5*LLN&gt;, &gt;1.75*ULN); neutrophils, lymphocytes(&lt;0.8*LLN, &gt;1.2*ULN); eosinophils, basophils, monocytes (&gt;1.2*ULN); total bilirubin (&gt;1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (&gt;3*ULN); total protein, albumin (&lt;0.8*LLN, &gt;1.2*ULN); creatinine, blood urea nitrogen (&gt;1.3*ULN); glucose (&lt;0.6*LLN, &gt;1.5*ULN); uric acid (&gt;1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (&lt;0.9*LLN, &gt;1.1*ULN); urine pH (&lt;4.5, &gt;8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [&gt;=] 1) in urine dipstick test; urine RBC, WBC (&gt;=20); hyaline casts (&gt;1), bacteria (&gt;20).</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study treatment. Here, &quot;number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Vital Sign Abnormalities</title>
        <description>Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) &lt;90 millimeter of mercury (mmHg), supine diastolic BP (DBP) &lt;50 mmHg, supine pulse rate &lt;40 beats per minute (bpm) or &gt;120 bpm. Maximum increase or decrease from baseline in supine SBP &gt;=30 mmHg and maximum increase or decrease from baseline in supine DBP &gt;=20 mmHg.</description>
        <time_frame>Baseline up to Follow-up (44 days)</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Sign Abnormalities</title>
          <description>Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) &lt;90 millimeter of mercury (mmHg), supine diastolic BP (DBP) &lt;50 mmHg, supine pulse rate &lt;40 beats per minute (bpm) or &gt;120 bpm. Maximum increase or decrease from baseline in supine SBP &gt;=30 mmHg and maximum increase or decrease from baseline in supine DBP &gt;=20 mmHg.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine SBP: &lt;90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="1.351" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="1" spread="1.091" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="0" spread="1.401" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP: &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine pulse rate: &lt;40 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine pulse rate: &gt;120 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum increase in Supine SBP: &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum increase in Supine DBP: &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum decrease in Supine SBP: &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum decrease in Supine DBP: &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Electrocardiogram (ECG) Abnormalities</title>
        <description>Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of &gt;=300 milliseconds (msec), maximum QRS interval &gt;=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to &lt;480 msec, 480 to &lt;500 msec and &gt;=500 msec, maximum of &gt;=25 percent (%) increase from baseline (IFB) value of &gt;200 msec and &gt;=50% for baseline value of less than or equal to (&lt;=) 200 msec for PR interval, maximum increase from baseline of &gt;=50% for QRS interval, maximum increase from baseline of &gt;=30 msec to &lt;60 msec and maximum increase from baseline of &gt;60 msec in QTCF interval (Fridericia's Correction).</description>
        <time_frame>Baseline up to Follow-up (44 days)</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study treatment. Here, &quot;n&quot; signifies the number of participants evaluable for the specific category.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Electrocardiogram (ECG) Abnormalities</title>
          <description>Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of &gt;=300 milliseconds (msec), maximum QRS interval &gt;=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to &lt;480 msec, 480 to &lt;500 msec and &gt;=500 msec, maximum of &gt;=25 percent (%) increase from baseline (IFB) value of &gt;200 msec and &gt;=50% for baseline value of less than or equal to (&lt;=) 200 msec for PR interval, maximum increase from baseline of &gt;=50% for QRS interval, maximum increase from baseline of &gt;=30 msec to &lt;60 msec and maximum increase from baseline of &gt;60 msec in QTCF interval (Fridericia's Correction).</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study treatment. Here, &quot;n&quot; signifies the number of participants evaluable for the specific category.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Max. PR Interval: &gt;=300 msec (n=72, 74, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="1.351" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="0" spread="1.091" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="0" spread="1.401" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. QRS Complex: &gt;=140 msec (n=72, 74, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. QTCF Interval: 450 to &lt;480 msec (n=72,74,72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. QTCF Interval: 480 to &lt;500 msec (n=72,74,72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. QTCF Interval: &gt;=500 msec (n=72, 74, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. PR Interval IFB: &gt;=25 or 50% (n=72, 74, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. QRS Complex IFB: &gt;=50% (n=72, 74, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. QTCF Interval IFB: 30 to&lt;60 msec (n=72,74,72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Max. QTCF Interval IFB: &gt;=60 msec (n=72,74,72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of &quot;Yes&quot; on &quot;actual attempt&quot;), preparatory acts toward imminent suicidal behavior =3 (&quot;Yes&quot; on &quot;preparatory acts or behavior&quot;), suicidal ideation =4 (&quot;Yes&quot; on &quot;wish to be dead&quot;, &quot;non-specific active suicidal thoughts&quot;, &quot;active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 (&quot;Yes&quot; on &quot;Has participant engaged in non-suicidal self-injurious behavior&quot;).</description>
        <time_frame>Screening, Baseline, Week 1, 2, 3, 4</time_frame>
        <population>Data was not collected for this outcome measure as per study team's decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of &quot;Yes&quot; on &quot;actual attempt&quot;), preparatory acts toward imminent suicidal behavior =3 (&quot;Yes&quot; on &quot;preparatory acts or behavior&quot;), suicidal ideation =4 (&quot;Yes&quot; on &quot;wish to be dead&quot;, &quot;non-specific active suicidal thoughts&quot;, &quot;active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 (&quot;Yes&quot; on &quot;Has participant engaged in non-suicidal self-injurious behavior&quot;).</description>
          <population>Data was not collected for this outcome measure as per study team's decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit</title>
        <description>PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.</description>
        <time_frame>End of treatment (Day 30), follow-up (Day 44)</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit</title>
          <description>PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study treatment.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="1.351" lower_limit="-0.49" upper_limit="0.28"/>
                    <measurement group_id="O2" value="-0.34" spread="1.091" lower_limit="-0.71" upper_limit="0.03"/>
                    <measurement group_id="O3" value="0.01" spread="1.401" lower_limit="-0.36" upper_limit="0.38"/>
                  </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>The ANCOVA model included treatment as fixed effects.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.76</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The ANCOVA model included treatment as fixed effects.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.41</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The ANCOVA model included treatment as fixed effects.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>-0.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.87</ci_lower_limit>
            <ci_upper_limit>0.17</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4</title>
        <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.</description>
        <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4</title>
          <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at week 1 (n= 74, 74, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="1.351" lower_limit="-0.69" upper_limit="-0.30"/>
                    <measurement group_id="O2" value="-0.41" spread="1.091" lower_limit="-0.61" upper_limit="-0.22"/>
                    <measurement group_id="O3" value="-0.70" spread="1.401" lower_limit="-0.90" upper_limit="-0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 2 (n= 65, 70, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" lower_limit="-1.21" upper_limit="-0.65"/>
                    <measurement group_id="O2" value="-0.98" lower_limit="-1.25" upper_limit="-0.70"/>
                    <measurement group_id="O3" value="-1.17" lower_limit="-1.44" upper_limit="-0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 3 (n= 62, 69, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.12" lower_limit="-1.43" upper_limit="-0.82"/>
                    <measurement group_id="O2" value="-1.09" lower_limit="-1.39" upper_limit="-0.80"/>
                    <measurement group_id="O3" value="-1.39" lower_limit="-1.68" upper_limit="-1.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 4 (n= 59, 64, 66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.22" lower_limit="-1.56" upper_limit="-0.87"/>
                    <measurement group_id="O2" value="-1.14" lower_limit="-1.48" upper_limit="-0.81"/>
                    <measurement group_id="O3" value="-1.58" lower_limit="-1.91" upper_limit="-1.25"/>
                  </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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.20</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.48</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.01</ci_lower_limit>
            <ci_upper_limit>0.56</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.24</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.43</ci_lower_limit>
            <ci_upper_limit>0.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.62</ci_lower_limit>
            <ci_upper_limit>0.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.23</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.58</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.39</ci_lower_limit>
            <ci_upper_limit>0.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.69</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.25</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.71</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.40</ci_lower_limit>
            <ci_upper_limit>0.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.84</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.28</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4</title>
        <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.</description>
        <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4</title>
          <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at week 1 (n= 74, 74, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.453" spread="18.2639" lower_limit="0.87" upper_limit="0.94"/>
                    <measurement group_id="O2" value="-5.830" spread="16.0979" lower_limit="0.89" upper_limit="0.97"/>
                    <measurement group_id="O3" value="-10.601" spread="17.4139" lower_limit="0.84" upper_limit="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 2 (n= 65, 70, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.190" spread="21.7655" lower_limit="0.76" upper_limit="0.87"/>
                    <measurement group_id="O2" value="-15.467" spread="20.4505" lower_limit="0.77" upper_limit="0.88"/>
                    <measurement group_id="O3" value="-17.682" spread="24.3704" lower_limit="0.73" upper_limit="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 3 (n= 62, 69, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.100" spread="25.5461"/>
                    <measurement group_id="O2" value="-17.167" spread="23.7288"/>
                    <measurement group_id="O3" value="-22.204" spread="23.2540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 4 (n= 59, 64, 66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.958" spread="25.5848"/>
                    <measurement group_id="O2" value="-17.072" spread="27.4016"/>
                    <measurement group_id="O3" value="-23.906" spread="28.0190"/>
                  </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: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.01</ci_lower_limit>
            <ci_upper_limit>0.12</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: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.06</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.06</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.06</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.04</ci_lower_limit>
            <ci_upper_limit>0.15</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: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.05</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.07</ci_lower_limit>
            <ci_upper_limit>0.16</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: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.16</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.09</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (&gt;=) 30 Percent and &gt;=50 Percent Reduction From Baseline</title>
        <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at &gt;=30 percent and &gt;=50 percent reduced from baseline were reported.</description>
        <time_frame>Baseline up to Week 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (&gt;=) 30 Percent and &gt;=50 Percent Reduction From Baseline</title>
          <description>Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at &gt;=30 percent and &gt;=50 percent reduced from baseline were reported.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;=30 percent response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="1.351" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="24" spread="1.091" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="31" spread="1.401" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=50 percent response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="12"/>
                  </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>&gt;=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.97</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>&gt;=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.43</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>2.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>&gt;=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.39</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>&gt;=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.81</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>1.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>&gt;=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.11</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>2.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>&gt;=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.73</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>1.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Withdrawn Due to Lack of Efficacy</title>
        <description>Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.</description>
        <time_frame>Baseline up to Week 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Withdrawn Due to Lack of Efficacy</title>
          <description>Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="1.351" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="0" spread="1.091" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="1" spread="1.401" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Withdrawal Due to Lack of Efficacy</title>
        <description>Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as &quot;Insufficient Clinical Response&quot;. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.</description>
        <time_frame>Baseline up to Week 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Withdrawal Due to Lack of Efficacy</title>
          <description>Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as &quot;Insufficient Clinical Response&quot;. Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="1.351" lower_limit="NA" upper_limit="NA">Outcome was to be assessed as time to event analysis by Kaplan-Meier estimates. However, median and 90% CI were not estimable since very few participants withdrew from study due to lack of efficacy: 2 in placebo group, 1 in naproxen group.</measurement>
                    <measurement group_id="O2" value="NA" spread="1.091" lower_limit="NA" upper_limit="NA">Outcome was to be assessed as time to event analysis by Kaplan-Meier estimates. However, median and 90% CI were not estimable since very few participants withdrew from study due to lack of efficacy: 2 in placebo group, 1 in naproxen group.</measurement>
                    <measurement group_id="O3" value="NA" spread="1.401" lower_limit="NA" upper_limit="NA">Outcome was to be assessed as time to event analysis by Kaplan-Meier estimates. However, median and 90% CI were not estimable since very few participants withdrew from study due to lack of efficacy: 2 in placebo group, 1 in naproxen group.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Using Rescue Medication</title>
        <description>Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.</description>
        <time_frame>Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Using Rescue Medication</title>
          <description>Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n= 74, 74, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" spread="1.351" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="35" spread="1.091" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="34" spread="1.401" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n= 67, 72, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n= 63, 69, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (59, 66, 67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Participants Used the Rescue Medication</title>
        <description>The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.</description>
        <time_frame>Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Participants Used the Rescue Medication</title>
          <description>The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n= 74, 74, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="2.62" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="1.7" spread="2.49" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="1.7" spread="2.44" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n= 67, 72, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="2.65"/>
                    <measurement group_id="O2" value="1.8" spread="2.77"/>
                    <measurement group_id="O3" value="1.6" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n= 63, 69, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="3.11"/>
                    <measurement group_id="O2" value="1.4" spread="2.22"/>
                    <measurement group_id="O3" value="1.5" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (59, 66, 67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="2.37"/>
                    <measurement group_id="O2" value="1.4" spread="2.15"/>
                    <measurement group_id="O3" value="1.4" spread="2.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Rescue Medication Used by the Participants</title>
        <description>The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.</description>
        <time_frame>Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Rescue Medication Used by the Participants</title>
          <description>The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n= 72, 70, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1388.9" spread="2703.97" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="1621.8" spread="4169.38" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="2064.5" spread="4298.80" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n= 65, 68, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1030.8" spread="1669.76"/>
                    <measurement group_id="O2" value="1594.1" spread="3708.11"/>
                    <measurement group_id="O3" value="1920.5" spread="4327.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n= 61, 65, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1172.1" spread="1955.52"/>
                    <measurement group_id="O2" value="1416.9" spread="3552.05"/>
                    <measurement group_id="O3" value="1740.5" spread="4361.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n= 58, 62, 67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1101.7" spread="2069.03"/>
                    <measurement group_id="O2" value="1348.8" spread="2925.65"/>
                    <measurement group_id="O3" value="1489.2" spread="3567.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3</title>
        <description>Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.</description>
        <time_frame>Baseline, Week 1, 2, 3</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3</title>
          <description>Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</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="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 74, 74, 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="5.47"/>
                    <measurement group_id="O2" value="9.4" spread="5.23"/>
                    <measurement group_id="O3" value="8.5" spread="5.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 1 (n= 73, 73, 73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="2.48"/>
                    <measurement group_id="O2" value="-0.5" spread="3.73"/>
                    <measurement group_id="O3" value="-1.2" spread="3.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 2 (n= 66, 71, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" spread="3.17"/>
                    <measurement group_id="O2" value="-1.3" spread="3.59"/>
                    <measurement group_id="O3" value="-1.6" spread="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at week 3 (n= 62, 67, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="3.24"/>
                    <measurement group_id="O2" value="-1.3" spread="3.39"/>
                    <measurement group_id="O3" value="-2.0" spread="4.21"/>
                  </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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.53</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.06</ci_lower_limit>
            <ci_upper_limit>0.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.53</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.80</ci_lower_limit>
            <ci_upper_limit>-0.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.73</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.53</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.15</ci_lower_limit>
            <ci_upper_limit>1.61</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.70</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.60</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.69</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-1.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.60</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.11</ci_lower_limit>
            <ci_upper_limit>-0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.59</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.57</ci_lower_limit>
            <ci_upper_limit>1.39</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.61</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.42</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-1.27</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.61</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.28</ci_lower_limit>
            <ci_upper_limit>-0.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.60</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.12</ci_lower_limit>
            <ci_upper_limit>1.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4</title>
        <description>Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4</title>
          <description>Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.00" spread="3.36" lower_limit="-1.67" upper_limit="-0.33"/>
                    <measurement group_id="O2" value="-1.64" spread="3.85" lower_limit="-2.35" upper_limit="-0.92"/>
                    <measurement group_id="O3" value="-2.43" spread="4.73" lower_limit="-3.14" upper_limit="-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 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.64</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.63</ci_lower_limit>
            <ci_upper_limit>0.35</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-1.43</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.40</ci_lower_limit>
            <ci_upper_limit>-0.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (PF-06372865-Naproxen)</param_type>
            <param_value>0.79</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.22</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4</title>
        <description>This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.</description>
        <time_frame>Baseline, Week 2, Week 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4</title>
          <description>This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</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="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total recall score: at Baseline (n= 74,74,74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.47" spread="5.118"/>
                    <measurement group_id="O2" value="22.92" spread="5.581"/>
                    <measurement group_id="O3" value="24.46" spread="5.455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total recall score: Change at Week 2 (n= 66,72,71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" spread="3.702" lower_limit="-0.28" upper_limit="0.62"/>
                    <measurement group_id="O2" value="0.57" spread="3.950" lower_limit="-1.03" upper_limit="-0.17"/>
                    <measurement group_id="O3" value="-0.30" spread="4.773" lower_limit="-0.44" upper_limit="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total recall score: Change at Week 4 (n= 56,66,66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.43" spread="3.637" lower_limit="-0.03" upper_limit="1.62"/>
                    <measurement group_id="O2" value="0.68" spread="3.522"/>
                    <measurement group_id="O3" value="0.11" spread="4.062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delayed Recall Score: at Baseline (n= 74,74,74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.59" spread="2.415"/>
                    <measurement group_id="O2" value="8.31" spread="2.828"/>
                    <measurement group_id="O3" value="8.59" spread="2.643"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delayed Recall Score:Change at Week 2 (n=66,72,71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="2.225"/>
                    <measurement group_id="O2" value="-0.57" spread="2.803"/>
                    <measurement group_id="O3" value="-0.06" spread="1.912"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Delayed Recall Score:Change at Week 4 (n=56,65,66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" spread="1.925"/>
                    <measurement group_id="O2" value="-0.28" spread="2.197"/>
                    <measurement group_id="O3" value="0.41" spread="1.831"/>
                  </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>Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.70</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.52</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.70</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.10</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.68</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.56</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-1.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.63</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.06</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-1.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.63</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.25</ci_lower_limit>
            <ci_upper_limit>-0.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.19</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.61</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.82</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.39</ci_lower_limit>
            <ci_upper_limit>-0.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.38</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.80</ci_lower_limit>
            <ci_upper_limit>0.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>-0.60</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.37</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.21</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>Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.85</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.42</ci_lower_limit>
            <ci_upper_limit>-0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.67</ci_lower_limit>
            <ci_upper_limit>0.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>-0.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.33</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.29</ci_lower_limit>
            <ci_upper_limit>-0.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chronic Low Back Pain (CLBP) Responder Index Analysis</title>
        <description>Participants were successful responders if they had any of the following: &gt;=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of &gt;=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.</description>
        <time_frame>Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Chronic Low Back Pain (CLBP) Responder Index Analysis</title>
          <description>Participants were successful responders if they had any of the following: &gt;=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of &gt;=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="2.62" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="0" spread="2.49" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="8" spread="2.44" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="2.65"/>
                    <measurement group_id="O2" value="8" spread="2.77"/>
                    <measurement group_id="O3" value="11" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" spread="3.11"/>
                    <measurement group_id="O2" value="8" spread="2.22"/>
                    <measurement group_id="O3" value="14" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" spread="2.37"/>
                    <measurement group_id="O2" value="11" spread="2.15"/>
                    <measurement group_id="O3" value="19" spread="2.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.98</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.61</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.04</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.33</ci_lower_limit>
            <ci_upper_limit>3.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.48</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4</title>
        <description>Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.</description>
        <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4</title>
          <description>Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 1 (n= 73, 73, 73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" lower_limit="-0.33" upper_limit="-0.06"/>
                    <measurement group_id="O2" value="-0.19" lower_limit="-0.33" upper_limit="-0.05"/>
                    <measurement group_id="O3" value="-0.34" lower_limit="-0.48" upper_limit="-0.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 2 (n= 66, 71, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" lower_limit="-0.40" upper_limit="-0.09"/>
                    <measurement group_id="O2" value="-0.28" lower_limit="-0.43" upper_limit="-0.13"/>
                    <measurement group_id="O3" value="-0.39" lower_limit="-0.55" upper_limit="-0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 3 (n= 62, 67, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" lower_limit="-0.62" upper_limit="-0.29"/>
                    <measurement group_id="O2" value="-0.31" lower_limit="-0.47" upper_limit="-0.14"/>
                    <measurement group_id="O3" value="-0.43" lower_limit="-0.60" upper_limit="-0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 4 (n= 58, 65, 65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" lower_limit="-0.52" upper_limit="-0.15"/>
                    <measurement group_id="O2" value="-0.21" lower_limit="-0.38" upper_limit="-0.03"/>
                    <measurement group_id="O3" value="-0.54" lower_limit="-0.71" upper_limit="-0.36"/>
                  </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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.12</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.35</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.26</ci_lower_limit>
            <ci_upper_limit>0.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.37</ci_lower_limit>
            <ci_upper_limit>0.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.33</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>0.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.14</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.10</ci_lower_limit>
            <ci_upper_limit>0.36</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.13</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.46</ci_lower_limit>
            <ci_upper_limit>0.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.08</ci_lower_limit>
            <ci_upper_limit>0.58</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change (PGI-C) Score</title>
        <description>PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.</description>
        <time_frame>Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change (PGI-C) Score</title>
          <description>PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 (n= 73, 73, 73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.32" lower_limit="3.14" upper_limit="3.49"/>
                    <measurement group_id="O2" value="3.15" lower_limit="2.97" upper_limit="3.32"/>
                    <measurement group_id="O3" value="2.95" lower_limit="2.77" upper_limit="3.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n= 66, 71, 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.12" lower_limit="2.91" upper_limit="3.33"/>
                    <measurement group_id="O2" value="3.04" lower_limit="2.83" upper_limit="3.24"/>
                    <measurement group_id="O3" value="2.83" lower_limit="2.63" upper_limit="3.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n= 62, 67, 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.01" lower_limit="2.81" upper_limit="3.22"/>
                    <measurement group_id="O2" value="2.94" lower_limit="2.74" upper_limit="3.14"/>
                    <measurement group_id="O3" value="2.63" lower_limit="2.43" upper_limit="2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n= 58, 65, 65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.04" lower_limit="2.81" upper_limit="3.27"/>
                    <measurement group_id="O2" value="2.93" lower_limit="2.72" upper_limit="3.15"/>
                    <measurement group_id="O3" value="2.61" lower_limit="2.39" upper_limit="2.82"/>
                  </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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.62</ci_lower_limit>
            <ci_upper_limit>-0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.15</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.05</ci_lower_limit>
            <ci_upper_limit>0.45</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.38</ci_lower_limit>
            <ci_upper_limit>0.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.29</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.58</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.18</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.09</ci_lower_limit>
            <ci_upper_limit>0.49</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.36</ci_lower_limit>
            <ci_upper_limit>0.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.67</ci_lower_limit>
            <ci_upper_limit>-0.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.03</ci_lower_limit>
            <ci_upper_limit>0.59</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: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (PF-06372865-Placebo)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.42</ci_lower_limit>
            <ci_upper_limit>0.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference (Naproxen-Placebo)</param_type>
            <param_value>-0.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>-0.12</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference(PF-06372865-Naproxen)</param_type>
            <param_value>0.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.19</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.02</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4</title>
        <description>Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.</description>
        <time_frame>Week 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
          </group>
          <group group_id="O2">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
          <group group_id="O3">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4</title>
          <description>Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;number of participants analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="73"/>
                <count group_id="O3" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Poor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="2.62" lower_limit="-1.50" upper_limit="-0.89"/>
                    <measurement group_id="O2" value="11" spread="2.49" lower_limit="-1.35" upper_limit="-0.71"/>
                    <measurement group_id="O3" value="5" spread="2.44" lower_limit="-1.77" upper_limit="-1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fair</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="2.65"/>
                    <measurement group_id="O2" value="18" spread="2.77"/>
                    <measurement group_id="O3" value="14" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="3.11"/>
                    <measurement group_id="O2" value="36" spread="2.22"/>
                    <measurement group_id="O3" value="37" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="2.37"/>
                    <measurement group_id="O2" value="8" spread="2.15"/>
                    <measurement group_id="O3" value="15" spread="2.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.85</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.46</ci_lower_limit>
            <ci_upper_limit>1.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.43</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>0.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.97</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.06</ci_lower_limit>
            <ci_upper_limit>3.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of PF-06372865</title>
        <description>Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was &lt;0.0100 nanogram per milliliter (ng/mL).</description>
        <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-06372865</title>
            <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of PF-06372865</title>
          <description>Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was &lt;0.0100 nanogram per milliliter (ng/mL).</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not collected at baseline since number of observations above lower limit of quantification (NALQ) = 0.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n= 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.57" spread="13.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n= 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.51" spread="45.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n= 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.65" spread="46.305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n= 65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.24" spread="41.975"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentration of Naproxen</title>
        <description>Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was &lt;1000 ng/mL.</description>
        <time_frame>Baseline, Week 1, 2, 3, 4</time_frame>
        <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Naproxen</title>
            <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentration of Naproxen</title>
          <description>Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was &lt;1000 ng/mL.</description>
          <population>FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, &quot;n&quot; signifies participants who were evaluable at the specified time point for each arm.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n= 73)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="317.0" spread="1963.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 (n= 74)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68150" spread="35213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2 (n= 72)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67830" spread="37004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 (n= 71)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67140" spread="38336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 (n= 65)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65650" spread="33419"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.</description>
        </group>
        <group group_id="E2">
          <title>PF-06372865</title>
          <description>Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.</description>
        </group>
        <group group_id="E3">
          <title>Naproxen</title>
          <description>Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</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="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="25" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Electrocardiogram abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Disturbance in attention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Hypersomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Sedation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Tinel's sign</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute prerenal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Paranasal sinus discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="74"/>
              </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 ClinicalTrials.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/NCT02262754
org study id: B7431006
nct id: NCT02262754
lead sponsor: 
has dmc: No
PF-06372865 In Subjects With Chronic Low Back Pain
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4
time frame: Baseline, Week 4
description: Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 28 days after the last dose of study treatment (Day 56)
description: An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
measure: Number of Participants With Laboratory Abnormalities
time frame: Baseline up to 28 days after the last dose of study treatment (Day 56)
description: Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).
measure: Number of Participants With Vital Sign Abnormalities
time frame: Baseline up to Follow-up (44 days)
description: Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
time frame: Baseline up to Follow-up (44 days)
description: Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).
measure: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Screening, Baseline, Week 1, 2, 3, 4
description: The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior =3 ("Yes" on "preparatory acts or behavior"), suicidal ideation =4 ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
measure: Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit
time frame: End of treatment (Day 30), follow-up (Day 44)
description: PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.
measure: Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4
time frame: Baseline, Week 1, 2, 3, 4
description: Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
measure: Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4
time frame: Baseline, Week 1, 2, 3, 4
description: Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
measure: Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline
time frame: Baseline up to Week 4
description: Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.
measure: Number of Participants Withdrawn Due to Lack of Efficacy
time frame: Baseline up to Week 4
description: Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.
measure: Time to Withdrawal Due to Lack of Efficacy
time frame: Baseline up to Week 4
description: Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as "Insufficient Clinical Response". Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.
measure: Number of Participants Using Rescue Medication
time frame: Week 1, 2, 3, 4
description: Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.
measure: Number of Days Participants Used the Rescue Medication
time frame: Week 1, 2, 3, 4
description: The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.
measure: Amount of Rescue Medication Used by the Participants
time frame: Week 1, 2, 3, 4
description: The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.
measure: Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3
time frame: Baseline, Week 1, 2, 3
description: Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
measure: Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
time frame: Baseline, Week 4
description: Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
measure: Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4
time frame: Baseline, Week 2, Week 4
description: This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.
measure: Chronic Low Back Pain (CLBP) Responder Index Analysis
time frame: Week 1, 2, 3, 4
description: Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.
measure: Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4
time frame: Baseline, Week 1, 2, 3, 4
description: Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.
measure: Patient Global Impression of Change (PGI-C) Score
time frame: Week 1, 2, 3, 4
description: PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.
measure: Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4
time frame: Week 4
description: Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.
measure: Plasma Concentration of PF-06372865
time frame: Baseline, Week 1, 2, 3, 4
description: Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).
measure: Plasma Concentration of Naproxen
time frame: Baseline, Week 1, 2, 3, 4
description: Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.
arm group label: PF-06372865
arm group type: Experimental
description: Daily BID dosing for 4 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Daily BID dosing for 4 weeks
arm group label: Naproxen
arm group type: Active Comparator
description: Daily BID dosing for 4 weeks
intervention type: Drug
intervention name: PF-06372865
description: Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks
arm group label: PF-06372865
intervention type: Drug
intervention name: Placebo
description: Placebo for PF-06372865 and placebo for naproxen daily
arm group label: Placebo
intervention type: Drug
intervention name: Naproxen
description: 500 mg BID for 4 weeks
arm group label: Naproxen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7431006&StudyName=A%20Randomized%2C%20Double%20Blind%2C%20Placebo-%20And%20Active-controlled%2C%204%20Week%2C%20Multi-center%2C%20Parallel%20Group%20Study%20Assessing%20The%20Analgesic%20Effect%2C%20Safety%20And%20Tolerability%20Of%20Pf-06372865%20In%20Subjects%20With%20Chronic%20Low%20Back%20Pain%20Using%20Naproxen%20As%20Positive%20Control
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Back Pain
mesh term: Low Back Pain
mesh term: Naproxen
mesh term: PF-06372865
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 