<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/NCT02187029</url>
  </required_header>
  <id_info>
    <org_study_id>B7911002</org_study_id>
    <nct_id>NCT02187029</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.</brief_title>
  <official_title>A Randomized, Double Blind, Third Party Open, Placebo Controlled Multi-center Study Of Efficacy, Safety And Tolerability Of Pf-06743649 In Gout Subjects</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>
      The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid&#xD;
      in subjects suffering from gout following 14 days of dosing, as well as assessing safety and&#xD;
      tolerability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    B7911002 was prematurely discontinued due to a safety concern that led to decision to terminate&#xD;
    the study on 10 Nov 2014&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Baseline of Serum Uric Acid</measure>
    <time_frame>Baseline (pre-dose Day 1)</time_frame>
    <description>An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14</measure>
    <time_frame>Day 14 Hour 24</time_frame>
  </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 last study drug administration (Day 42)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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/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 pre-treatment state AEs included both serious and non-serious events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Laboratory Test Abnormalities</measure>
    <time_frame>Baseline up to follow up visit (Day 25-29)</time_frame>
    <description>Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Potentially Clinically Significant Vital Signs Findings</measure>
    <time_frame>Baseline up to follow up visit (Day 25-29)</time_frame>
    <description>Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (&lt;) 90 millimeters of mercury (mmHg) or more than or equal to (&gt;=)30 mmHg change from baseline, diastolic BP of &lt;50 mmHg or &gt;=20 mmHg change from baseline, Supine pulse rate of &lt;40 or more than (&gt;)120 beats per minute (bpm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria</measure>
    <time_frame>Baseline up to Day 16</time_frame>
    <description>Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) &gt;=300 milliseconds (msec) or increase from baseline &gt;=25% when baseline &gt;200 msec or increase from baseline &gt;=50% when baseline less than or equal to (&lt;=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval &gt;=140 msec or &gt;=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to &lt; 480 msec, 480 to &lt;500 msec and &gt;=500 msec, or an increase of 30 to &lt;60 msec or &gt;=60 msec from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up</measure>
    <time_frame>Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reaching Serum Uric Acid Levels &lt;6, &lt;5 and &lt;4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14</measure>
    <time_frame>24 hours post dose on Day 7 and Day 14</time_frame>
    <description>Number of participants reaching serum uric acid levels &lt;6, &lt;5 and &lt;4 mg/dL at 7 and 14 days after initiation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Gout Flare Attacks</measure>
    <time_frame>Baseline up to Day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Gout Flare Attacks</measure>
    <time_frame>Baseline up to Day 42</time_frame>
    <description>Duration of gout flare attacks with participants who developed gout flare attacks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14</measure>
    <time_frame>0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14</time_frame>
    <description>Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14</measure>
    <time_frame>Day 1, Day 7, and Day 14</time_frame>
    <description>PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up</measure>
    <time_frame>Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)</time_frame>
    <description>Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up</measure>
    <time_frame>Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14</measure>
    <time_frame>Baseline, Day 1, Day 7 and Day 14</time_frame>
    <description>Change from baseline in urinary uric acid cumulative amounts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14</measure>
    <time_frame>Baseline, Day 1, Day 7 and Day 14</time_frame>
    <description>Change from baseline in urinary xanthine cumulative amounts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14</measure>
    <time_frame>Baseline, Day 1, Day 7 and Day 14</time_frame>
    <description>Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>PF-06743649 dose level 1 (Cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for PF-06743649 (Cohort 1)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06743649 dose level 2 (Cohort 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo for PF-06743649 (Cohort 2)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06743649</intervention_name>
    <description>Daily dosing (dose level 1) tablet for 14 days</description>
    <arm_group_label>PF-06743649 dose level 1 (Cohort 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily dosing (tablet) for 14 days</description>
    <arm_group_label>Placebo for PF-06743649 (Cohort 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06743649</intervention_name>
    <description>Daily dosing (dose level 2) tablet(s) for 14 days</description>
    <arm_group_label>PF-06743649 dose level 2 (Cohort 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily dosing (tablets) for 14 days</description>
    <arm_group_label>Placebo for PF-06743649 (Cohort 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject meets the diagnosis of gout as per the American Rheumatism Association&#xD;
             Criteria for the Classification of acute Arthritis of Primary Gout.&#xD;
&#xD;
          -  Subjects taking urate lowering therapy at the time of screening must be willing to&#xD;
             discontinue their prior urate lowering therapy from the time of Screening Visit 1&#xD;
             until completion of the study period Day 16.&#xD;
&#xD;
          -  Subjects taking urate lowering therapy at the time of screening must have a serum&#xD;
             urate level of &gt;= 8.0 mg/dL at time of the second screening visit.&#xD;
&#xD;
          -  Subjects NOT taking urate lowering therapy at the time of screening must have a serum&#xD;
             urate level of &gt;= 8.0 mg/dL at both screening visits 1 and 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive medical history or current evidence of medical or psychiatric&#xD;
             condition/disease, or ECG or laboratory abnormality that may increase the risk&#xD;
             associated with study participation or investigational product administration or may&#xD;
             interfere with the interpretation of study results and, in the judgment of the&#xD;
             Investigator, would make the subject inappropriate for entry into this study.&#xD;
&#xD;
          -  Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline,&#xD;
             National Kidney Foundation)12; with GFR &lt; 60 mL/min/1.73m2 calculated by the&#xD;
             Cockcroft-Gault equation.&#xD;
&#xD;
          -  Subjects with current tophaceous gout.&#xD;
&#xD;
          -  Gout flare that has not resolved for at least 2 weeks prior to randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 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>MRA Clinical Research, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Research Associates, Inc.</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vince and Associates Clinical Research Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vince and Associates Clinical Research, Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</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=B7911002&amp;StudyName=Efficacy%2C%20Safety%20And%20Tolerability%20Of%20PF-06743649%20In%20Gout%20Subjects.%0A</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>December 8, 2015</results_first_submitted>
  <results_first_submitted_qc>September 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 11, 2016</results_first_posted>
  <last_update_submitted>September 23, 2016</last_update_submitted>
  <last_update_submitted_qc>September 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyperuricemia</keyword>
  <keyword>gout</keyword>
  <keyword>serum uric acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gout</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
          <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1: PF-06743649 40 mg</title>
          <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2: PF-06743649 5 mg</title>
          <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 1 and 2: Placebo</title>
          <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="3"/>
              </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="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
          <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1: PF-06743649 40 mg</title>
          <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2: PF-06743649 5 mg</title>
          <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 1 and 2: Placebo</title>
          <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="30"/>
          </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="47.1" spread="8.1"/>
                    <measurement group_id="B2" value="50.7" spread="9.7"/>
                    <measurement group_id="B3" value="43.4" spread="9.8"/>
                    <measurement group_id="B4" value="46.8" spread="9.3"/>
                    <measurement group_id="B5" value="46.0" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Baseline of Serum Uric Acid</title>
        <description>An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.</description>
        <time_frame>Baseline (pre-dose Day 1)</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline of Serum Uric Acid</title>
          <description>An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.</description>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.</population>
          <units>milligram per deciliter(mg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.800" spread="1.1402"/>
                    <measurement group_id="O2" value="9.100" spread="0.8185"/>
                    <measurement group_id="O3" value="8.991" spread="0.6549"/>
                    <measurement group_id="O4" value="9.278" spread="0.9536"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14</title>
        <time_frame>Day 14 Hour 24</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to &quot;Cohort 2: PF-06743649 5 mg&quot; termination after 2 days of dosing.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14</title>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment. Number of participants analyzed is number of evaluable participants for this outcome measure. No data due to &quot;Cohort 2: PF-06743649 5 mg&quot; termination after 2 days of dosing.</population>
          <units>percent (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-52.891" spread="6.1661"/>
                    <measurement group_id="O2" value="-67.480" spread="1.1498"/>
                    <measurement group_id="O4" value="-1.381" spread="9.1430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-52.550</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-56.320</ci_lower_limit>
            <ci_upper_limit>-48.780</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-66.310</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-71.310</ci_lower_limit>
            <ci_upper_limit>-61.540</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 drug without regard to possibility of causal relationship. An 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/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 pre-treatment state AEs included both serious and non-serious events.</description>
        <time_frame>Baseline up to 28 days after last study drug administration (Day 42)</time_frame>
        <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</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 drug without regard to possibility of causal relationship. An 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/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 pre-treatment state AEs included both serious and non-serious events.</description>
          <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with SAEs</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Laboratory Test Abnormalities</title>
        <description>Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).</description>
        <time_frame>Baseline up to follow up visit (Day 25-29)</time_frame>
        <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Test Abnormalities</title>
          <description>Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).</description>
          <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Potentially Clinically Significant Vital Signs Findings</title>
        <description>Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (&lt;) 90 millimeters of mercury (mmHg) or more than or equal to (&gt;=)30 mmHg change from baseline, diastolic BP of &lt;50 mmHg or &gt;=20 mmHg change from baseline, Supine pulse rate of &lt;40 or more than (&gt;)120 beats per minute (bpm).</description>
        <time_frame>Baseline up to follow up visit (Day 25-29)</time_frame>
        <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potentially Clinically Significant Vital Signs Findings</title>
          <description>Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (&lt;) 90 millimeters of mercury (mmHg) or more than or equal to (&gt;=)30 mmHg change from baseline, diastolic BP of &lt;50 mmHg or &gt;=20 mmHg change from baseline, Supine pulse rate of &lt;40 or more than (&gt;)120 beats per minute (bpm).</description>
          <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine Systolic BP (mmHg) &lt;90</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Diastolic BP (mmHg) &lt;50</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Pulse Rate (bpm) &lt;40</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Pulse Rate (bpm) &gt;120</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase Supine Systolic BP (mmHg) &gt;=30</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 group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase Supine Diastolic BP (mmHg) &gt;=20</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 group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease Supine Systolic BP (mmHg) &gt;=30</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decrease Supine Diastolic BP (mmHg) &gt;=20</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria</title>
        <description>Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) &gt;=300 milliseconds (msec) or increase from baseline &gt;=25% when baseline &gt;200 msec or increase from baseline &gt;=50% when baseline less than or equal to (&lt;=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval &gt;=140 msec or &gt;=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to &lt; 480 msec, 480 to &lt;500 msec and &gt;=500 msec, or an increase of 30 to &lt;60 msec or &gt;=60 msec from baseline.</description>
        <time_frame>Baseline up to Day 16</time_frame>
        <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria</title>
          <description>Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) &gt;=300 milliseconds (msec) or increase from baseline &gt;=25% when baseline &gt;200 msec or increase from baseline &gt;=50% when baseline less than or equal to (&lt;=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval &gt;=140 msec or &gt;=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to &lt; 480 msec, 480 to &lt;500 msec and &gt;=500 msec, or an increase of 30 to &lt;60 msec or &gt;=60 msec from baseline.</description>
          <population>The safety analysis population included all participants who received at least 1 dose of study medication.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR (msec) &gt;=300</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS complex (msec) &gt;=140</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF (msec) 450-&lt;480</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF (msec) 480-&lt;500</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF (msec) &gt;=500</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR increase from baseline &gt;=25/50%</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS complex increase from baseline &gt;=50%</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF increase from baseline 30 to &lt;60 msec</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF increase from baseline &gt;=60 msec</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up</title>
        <time_frame>Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up</title>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.80" spread="1.140"/>
                    <measurement group_id="O2" value="9.10" spread="0.819"/>
                    <measurement group_id="O3" value="8.99" spread="0.655"/>
                    <measurement group_id="O4" value="9.28" spread="0.954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 1 (n=6,3,11, 9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.194"/>
                    <measurement group_id="O2" value="-0.50" spread="0.436"/>
                    <measurement group_id="O3" value="-0.51" spread="0.353"/>
                    <measurement group_id="O4" value="0.11" spread="0.190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 2 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.69" spread="0.261"/>
                    <measurement group_id="O2" value="-1.17" spread="0.839"/>
                    <measurement group_id="O3" value="-1.27" spread="0.403"/>
                    <measurement group_id="O4" value="-0.02" spread="0.156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 4 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.47" spread="0.293"/>
                    <measurement group_id="O2" value="-3.07" spread="0.115"/>
                    <measurement group_id="O3" value="-2.30" spread="0.382"/>
                    <measurement group_id="O4" value="-0.12" spread="0.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 8 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.00" spread="0.716"/>
                    <measurement group_id="O2" value="-3.87" spread="0.473"/>
                    <measurement group_id="O3" value="-2.77" spread="0.623"/>
                    <measurement group_id="O4" value="-0.23" spread="0.320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 12 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.77" spread="0.704"/>
                    <measurement group_id="O2" value="-3.83" spread="0.577"/>
                    <measurement group_id="O3" value="-2.74" spread="0.721"/>
                    <measurement group_id="O4" value="-0.19" spread="0.389"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 24 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.69" spread="0.664"/>
                    <measurement group_id="O2" value="-3.43" spread="0.757"/>
                    <measurement group_id="O3" value="-2.04" spread="0.770"/>
                    <measurement group_id="O4" value="-0.18" spread="0.396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 (n=7,3,10,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.13" spread="0.921"/>
                    <measurement group_id="O2" value="-4.50" spread="0.529"/>
                    <measurement group_id="O3" value="-3.02" spread="0.925"/>
                    <measurement group_id="O4" value="0.08" spread="0.342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, pre-dose (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.60" spread="0.945"/>
                    <measurement group_id="O2" value="-5.75" spread="0.212"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.07" spread="0.734"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 1 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.64" spread="0.846"/>
                    <measurement group_id="O2" value="-5.75" spread="0.212"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.03" spread="0.787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 2 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.94" spread="0.838"/>
                    <measurement group_id="O2" value="-6.10" spread="0.283"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.05" spread="0.797"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 4 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.44" spread="0.873"/>
                    <measurement group_id="O2" value="-6.60" spread="0.283"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.22" spread="0.731"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 8 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.49" spread="0.996"/>
                    <measurement group_id="O2" value="-6.60" spread="0.141"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.38" spread="0.578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 12 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.24" spread="1.037"/>
                    <measurement group_id="O2" value="-6.45" spread="0.071"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.25" spread="0.599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 24 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.73" spread="0.955"/>
                    <measurement group_id="O2" value="-5.90" spread="0.141"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.17" spread="0.794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.80" spread="0.961"/>
                    <measurement group_id="O2" value="-5.75" spread="0.071"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.17" spread="0.845"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, pre-dose (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.57" spread="0.900"/>
                    <measurement group_id="O2" value="-5.75" spread="0.636"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.22" spread="0.747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 1 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.83" spread="0.799"/>
                    <measurement group_id="O2" value="-6.05" spread="0.495"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.23" spread="0.659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 2 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.35" spread="0.846"/>
                    <measurement group_id="O2" value="-6.35" spread="0.495"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.33" spread="0.680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 4 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.02" spread="0.906"/>
                    <measurement group_id="O2" value="-6.80" spread="0.566"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.55" spread="0.638"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 8 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.93" spread="1.001"/>
                    <measurement group_id="O2" value="-6.85" spread="0.636"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.33" spread="0.781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 12 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.67" spread="1.124"/>
                    <measurement group_id="O2" value="-6.60" spread="0.566"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.28" spread="0.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 24 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.85" spread="0.940"/>
                    <measurement group_id="O2" value="-5.90" spread="0.424"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.20" spread="0.834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up (Day 25-29) (n=6,3,10,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="1.422"/>
                    <measurement group_id="O2" value="-2.27" spread="2.593"/>
                    <measurement group_id="O3" value="0.45" spread="0.938"/>
                    <measurement group_id="O4" value="-0.30" spread="1.648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-0.55</ci_lower_limit>
            <ci_upper_limit>-0.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.62</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>-0.95</ci_lower_limit>
            <ci_upper_limit>-0.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.10</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>-1.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.86</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>-2.38</ci_lower_limit>
            <ci_upper_limit>-1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.83</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>-2.18</ci_lower_limit>
            <ci_upper_limit>-1.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.20</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>-1.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.48</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>-2.89</ci_lower_limit>
            <ci_upper_limit>-2.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.30</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.29</ci_lower_limit>
            <ci_upper_limit>-2.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.80</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>-3.39</ci_lower_limit>
            <ci_upper_limit>-2.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.72</ci_lower_limit>
            <ci_upper_limit>-2.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day7, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.40</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.03</ci_lower_limit>
            <ci_upper_limit>-2.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.30</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>-3.82</ci_lower_limit>
            <ci_upper_limit>-2.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.20</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>-3.72</ci_lower_limit>
            <ci_upper_limit>-2.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.81</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.27</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.30</ci_lower_limit>
            <ci_upper_limit>-2.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 11</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.35</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.19</ci_lower_limit>
            <ci_upper_limit>-3.92</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.32</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>-4.75</ci_lower_limit>
            <ci_upper_limit>-3.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.55</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.25</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.02</ci_lower_limit>
            <ci_upper_limit>-4.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.27</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.47</ci_lower_limit>
            <ci_upper_limit>-4.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.22</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.83</ci_lower_limit>
            <ci_upper_limit>-5.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.57</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>-6.08</ci_lower_limit>
            <ci_upper_limit>-5.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.34</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>-5.86</ci_lower_limit>
            <ci_upper_limit>-4.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.25</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.12</ci_lower_limit>
            <ci_upper_limit>-4.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Follow-up, Day 25-29</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.97</ci_lower_limit>
            <ci_upper_limit>0.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.62</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>-0.92</ci_lower_limit>
            <ci_upper_limit>-0.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-1.18</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>-1.61</ci_lower_limit>
            <ci_upper_limit>-0.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.91</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>-3.14</ci_lower_limit>
            <ci_upper_limit>-2.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.70</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>-4.36</ci_lower_limit>
            <ci_upper_limit>-3.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.84</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>-4.28</ci_lower_limit>
            <ci_upper_limit>-3.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-3.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.26</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-3.94</ci_lower_limit>
            <ci_upper_limit>-3.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 3</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-4.76</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>-5.29</ci_lower_limit>
            <ci_upper_limit>-4.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.81</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.45</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.62</ci_lower_limit>
            <ci_upper_limit>-5.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.84</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.49</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.72</ci_lower_limit>
            <ci_upper_limit>-4.95</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.55</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.17</ci_lower_limit>
            <ci_upper_limit>-5.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.51</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>-7.46</ci_lower_limit>
            <ci_upper_limit>-5.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.29</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.43</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.07</ci_lower_limit>
            <ci_upper_limit>-5.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.44</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.03</ci_lower_limit>
            <ci_upper_limit>-5.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.50</ci_lower_limit>
            <ci_upper_limit>-4.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Day 11</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.62</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>-6.59</ci_lower_limit>
            <ci_upper_limit>-4.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.42</ci_lower_limit>
            <ci_upper_limit>-5.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.39</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.67</ci_lower_limit>
            <ci_upper_limit>-5.24</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.41</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.90</ci_lower_limit>
            <ci_upper_limit>-5.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.42</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>-7.03</ci_lower_limit>
            <ci_upper_limit>-5.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.64</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.41</ci_lower_limit>
            <ci_upper_limit>-5.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-6.40</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.18</ci_lower_limit>
            <ci_upper_limit>-5.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-5.77</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>-6.47</ci_lower_limit>
            <ci_upper_limit>-5.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Follow-up, Day 25-29</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-2.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.26</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.96</ci_lower_limit>
            <ci_upper_limit>-0.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reaching Serum Uric Acid Levels &lt;6, &lt;5 and &lt;4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14</title>
        <description>Number of participants reaching serum uric acid levels &lt;6, &lt;5 and &lt;4 mg/dL at 7 and 14 days after initiation.</description>
        <time_frame>24 hours post dose on Day 7 and Day 14</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reaching Serum Uric Acid Levels &lt;6, &lt;5 and &lt;4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14</title>
          <description>Number of participants reaching serum uric acid levels &lt;6, &lt;5 and &lt;4 mg/dL at 7 and 14 days after initiation.</description>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 (&lt;6.0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 (&lt;5.0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7 (&lt;4.0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 (&lt;6.0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 (&lt;5.0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 (&lt;4.0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence and Severity of Gout Flare Attacks</title>
        <time_frame>Baseline up to Day 42</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence and Severity of Gout Flare Attacks</title>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Gout Flare Attacks</title>
        <description>Duration of gout flare attacks with participants who developed gout flare attacks.</description>
        <time_frame>Baseline up to Day 42</time_frame>
        <population>Participants who developed gout flare attacks (Duration was not assessed as no participant developed gout flare attacks).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Gout Flare Attacks</title>
          <description>Duration of gout flare attacks with participants who developed gout flare attacks.</description>
          <population>Participants who developed gout flare attacks (Duration was not assessed as no participant developed gout flare attacks).</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 group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14</title>
        <description>Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).</description>
        <time_frame>0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14</time_frame>
        <population>All participants randomized and treated who have at least 1 measureable concentration; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14</title>
          <description>Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).</description>
          <population>All participants randomized and treated who have at least 1 measureable concentration; n=number of participants analyzed in each respective 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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, Hour 0 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not reported because the observations were not above lower limit of quantification.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data was not reported because the observations were not above lower limit of quantification.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Data was not reported because the observations were not above lower limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 1 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.8" spread="84.336"/>
                    <measurement group_id="O2" value="1097" spread="1011.8"/>
                    <measurement group_id="O3" value="371.3" spread="239.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 2 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196.6" spread="47.367"/>
                    <measurement group_id="O2" value="1570" spread="416.77"/>
                    <measurement group_id="O3" value="454.7" spread="141.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 4 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.8" spread="34.342"/>
                    <measurement group_id="O2" value="1081" spread="189.22"/>
                    <measurement group_id="O3" value="282.4" spread="106.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 8 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.27" spread="19.596"/>
                    <measurement group_id="O2" value="523.3" spread="108.89"/>
                    <measurement group_id="O3" value="142.7" spread="87.111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 12 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.84" spread="13.738"/>
                    <measurement group_id="O2" value="229.3" spread="36.665"/>
                    <measurement group_id="O3" value="99.27" spread="70.301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 24 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.586" spread="10.183"/>
                    <measurement group_id="O2" value="86.67" spread="18.434"/>
                    <measurement group_id="O3" value="48.90" spread="49.583"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 0 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.50" spread="10.560"/>
                    <measurement group_id="O2" value="154.0" spread="41.012"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 1 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185.9" spread="102.26"/>
                    <measurement group_id="O2" value="1275" spread="261.63"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 2 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211.7" spread="95.552"/>
                    <measurement group_id="O2" value="2715" spread="487.90"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 4 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137.3" spread="43.222"/>
                    <measurement group_id="O2" value="1520" spread="183.85"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 8 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.59" spread="19.509"/>
                    <measurement group_id="O2" value="697.0" spread="49.497"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 12 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.30" spread="16.272"/>
                    <measurement group_id="O2" value="457.5" spread="78.489"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 24 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.50" spread="10.356"/>
                    <measurement group_id="O2" value="147.0" spread="31.113"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 0 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.08" spread="27.363"/>
                    <measurement group_id="O2" value="157.5" spread="43.134"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 1 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="736.7" spread="483.18"/>
                    <measurement group_id="O2" value="1995" spread="417.19"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 2 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="729.5" spread="218.79"/>
                    <measurement group_id="O2" value="2140" spread="325.27"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 4 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429.5" spread="165.51"/>
                    <measurement group_id="O2" value="1480" spread="325.27"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 8 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245.8" spread="99.385"/>
                    <measurement group_id="O2" value="687.0" spread="96.167"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 12 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.3" spread="73.480"/>
                    <measurement group_id="O2" value="400.0" spread="74.953"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 24 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.27" spread="34.849"/>
                    <measurement group_id="O2" value="133.5" spread="13.435"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14</title>
        <description>PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).</description>
        <time_frame>Day 1, Day 7, and Day 14</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14</title>
          <description>PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).</description>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective 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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, Hour 0 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not reported because the observations were not above lower limit of quantification.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Data was not reported because the observations were not above lower limit of quantification.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Data was not reported because the observations were not above lower limit of quantification.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 1 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.713" spread="6.6738"/>
                    <measurement group_id="O2" value="79.62" spread="82.093"/>
                    <measurement group_id="O3" value="13.81" spread="10.519"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 2 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.69" spread="14.265"/>
                    <measurement group_id="O2" value="245.6" spread="182.75"/>
                    <measurement group_id="O3" value="49.30" spread="26.599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 4 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.07" spread="7.3081"/>
                    <measurement group_id="O2" value="395.0" spread="69.936"/>
                    <measurement group_id="O3" value="59.21" spread="29.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 8 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.09" spread="5.4462"/>
                    <measurement group_id="O2" value="261.3" spread="53.003"/>
                    <measurement group_id="O3" value="38.25" spread="18.527"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 12 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.46" spread="3.4996"/>
                    <measurement group_id="O2" value="156.3" spread="22.591"/>
                    <measurement group_id="O3" value="25.67" spread="13.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 24 (n=7,3,11)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.059" spread="2.8621"/>
                    <measurement group_id="O2" value="76.27" spread="23.811"/>
                    <measurement group_id="O3" value="12.76" spread="7.3997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 0 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.259" spread="3.5055"/>
                    <measurement group_id="O2" value="70.50" spread="11.597"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 1 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.00" spread="9.8895"/>
                    <measurement group_id="O2" value="107.0" spread="1.4142"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 2 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.83" spread="20.763"/>
                    <measurement group_id="O2" value="344.0" spread="49.497"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 4 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.26" spread="13.353"/>
                    <measurement group_id="O2" value="397.0" spread="9.8995"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 8 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.64" spread="9.2428"/>
                    <measurement group_id="O2" value="261.0" spread="0.00000"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 12 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.67" spread="5.5011"/>
                    <measurement group_id="O2" value="167.5" spread="23.335"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 24 (n=7,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.470" spread="3.7998"/>
                    <measurement group_id="O2" value="91.80" spread="1.9799"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 0 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.99" spread="9.6890"/>
                    <measurement group_id="O2" value="76.60" spread="9.4752"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 1 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.72" spread="37.910"/>
                    <measurement group_id="O2" value="171.0" spread="26.870"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 2 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139.3" spread="53.432"/>
                    <measurement group_id="O2" value="390.0" spread="117.38"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 4 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.3" spread="37.255"/>
                    <measurement group_id="O2" value="364.0" spread="18.385"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 8 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.82" spread="39.810"/>
                    <measurement group_id="O2" value="280.5" spread="9.1924"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 12 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.07" spread="27.960"/>
                    <measurement group_id="O2" value="162.0" spread="1.4142"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 24 (n=6,2,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.32" spread="14.608"/>
                    <measurement group_id="O2" value="81.35" spread="1.2021"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up</title>
        <description>Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.</description>
        <time_frame>Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up</title>
          <description>Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.</description>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
          <units>micrograms per milliliter (mcg/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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2519" spread="0.04316"/>
                    <measurement group_id="O2" value="0.2680" spread="0.10095"/>
                    <measurement group_id="O3" value="0.2102" spread="0.04037"/>
                    <measurement group_id="O4" value="0.2257" spread="0.05304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 1 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0473" spread="0.05949"/>
                    <measurement group_id="O2" value="0.1057" spread="0.02155"/>
                    <measurement group_id="O3" value="-0.0192" spread="0.04214"/>
                    <measurement group_id="O4" value="-0.0112" spread="0.08230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 2 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0330" spread="0.03844"/>
                    <measurement group_id="O2" value="0.3667" spread="0.27216"/>
                    <measurement group_id="O3" value="0.0346" spread="0.05090"/>
                    <measurement group_id="O4" value="-0.0220" spread="0.03653"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 4 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0826" spread="0.04922"/>
                    <measurement group_id="O2" value="0.3317" spread="0.11558"/>
                    <measurement group_id="O3" value="-0.0306" spread="0.05783"/>
                    <measurement group_id="O4" value="-0.0511" spread="0.06510"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 8 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0859" spread="0.07603"/>
                    <measurement group_id="O2" value="0.1947" spread="0.14431"/>
                    <measurement group_id="O3" value="-0.0918" spread="0.02295"/>
                    <measurement group_id="O4" value="-0.0982" spread="0.3674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 12 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1117" spread="0.04270"/>
                    <measurement group_id="O2" value="0.0847" spread="0.11634"/>
                    <measurement group_id="O3" value="-0.0921" spread="0.03801"/>
                    <measurement group_id="O4" value="-0.0786" spread="0.05731"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 24 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0167" spread="0.08149"/>
                    <measurement group_id="O2" value="0.1927" spread="0.04879"/>
                    <measurement group_id="O3" value="0.0140" spread="0.03411"/>
                    <measurement group_id="O4" value="0.0233" spread="0.10687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, pre-dose (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0362" spread="0.07118"/>
                    <measurement group_id="O2" value="0.1450" spread="0.00283"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.0177" spread="0.13598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 1 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0061" spread="0.10488"/>
                    <measurement group_id="O2" value="0.1765" spread="0.07566"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0170" spread="0.07475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 2 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0231" spread="0.05070"/>
                    <measurement group_id="O2" value="0.5300" spread="0.21779"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0098" spread="0.08066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 4 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0147" spread="0.06839"/>
                    <measurement group_id="O2" value="0.4995" spread="0.14920"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0233" spread="0.07942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 8 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1086" spread="0.04749"/>
                    <measurement group_id="O2" value="0.3010" spread="0.14425"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0843" spread="0.05064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 12 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1276" spread="0.04658"/>
                    <measurement group_id="O2" value="-0.0535" spread="0.01909"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0750" spread="0.04685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 24 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0540" spread="0.05434"/>
                    <measurement group_id="O2" value="0.1465" spread="0.07990"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0242" spread="0.06072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, pre-dose (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0290" spread="0.05418"/>
                    <measurement group_id="O2" value="0.1540" spread="0.07778"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0120" spread="0.02367"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 1 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0607" spread="0.06662"/>
                    <measurement group_id="O2" value="0.3515" spread="0.10819"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0008" spread="0.02699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 2 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1353" spread="0.09010"/>
                    <measurement group_id="O2" value="0.5960" spread="0.01131"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.0330" spread="0.09579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 4 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0148" spread="0.09997"/>
                    <measurement group_id="O2" value="0.5595" spread="0.00212"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0210" spread="0.07869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 8 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0655" spread="0.08041"/>
                    <measurement group_id="O2" value="0.2030" spread="0.11738"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0778" spread="0.06107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 12 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0986" spread="0.04973"/>
                    <measurement group_id="O2" value="0.1175" spread="0.18031"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0801" spread="0.04477"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 24 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0172" spread="0.08536"/>
                    <measurement group_id="O2" value="0.1695" spread="0.08132"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.0242" spread="0.06158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up (Day 25-29) (n=6,3,10,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3710" spread="0.92324"/>
                    <measurement group_id="O2" value="0.8263" spread="0.77448"/>
                    <measurement group_id="O3" value="0.1161" spread="0.18229"/>
                    <measurement group_id="O4" value="0.2299" spread="0.44888"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0355</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0423</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1103</ci_lower_limit>
            <ci_upper_limit>0.0394</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0152</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0631</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1269</ci_lower_limit>
            <ci_upper_limit>0.0966</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0331</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0422</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1078</ci_lower_limit>
            <ci_upper_limit>0.0417</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0035</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0443</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0750</ci_lower_limit>
            <ci_upper_limit>0.0820</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0502</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0367</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1153</ci_lower_limit>
            <ci_upper_limit>0.0149</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0080</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0553</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1058</ci_lower_limit>
            <ci_upper_limit>0.0899</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0539</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0561</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1538</ci_lower_limit>
            <ci_upper_limit>0.0460</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0109</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0506</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0793</ci_lower_limit>
            <ci_upper_limit>0.1010</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0330</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0496</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0554</ci_lower_limit>
            <ci_upper_limit>0.1213</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0086</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0459</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0733</ci_lower_limit>
            <ci_upper_limit>0.0905</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0244</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0349</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0865</ci_lower_limit>
            <ci_upper_limit>0.0378</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0526</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0251</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0973</ci_lower_limit>
            <ci_upper_limit>-0.0079</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0298</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0331</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0889</ci_lower_limit>
            <ci_upper_limit>0.0292</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0167</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0268</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0649</ci_lower_limit>
            <ci_upper_limit>0.0315</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0616</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0337</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0010</ci_lower_limit>
            <ci_upper_limit>0.1222</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1025</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0512</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0104</ci_lower_limit>
            <ci_upper_limit>0.1945</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0062</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0495</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0827</ci_lower_limit>
            <ci_upper_limit>0.0952</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0124</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0443</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0672</ci_lower_limit>
            <ci_upper_limit>0.0919</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0186</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0408</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0918</ci_lower_limit>
            <ci_upper_limit>0.0547</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.0413</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0433</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.1192</ci_lower_limit>
            <ci_upper_limit>0.0365</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Follow-up, Day 25-29</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.4011</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3916</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2968</ci_lower_limit>
            <ci_upper_limit>1.0990</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1175</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0537</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0223</ci_lower_limit>
            <ci_upper_limit>0.2127</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.3845</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0802</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2424</ci_lower_limit>
            <ci_upper_limit>0.5266</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.3812</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0536</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2862</ci_lower_limit>
            <ci_upper_limit>0.4762</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.2841</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0563</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1843</ci_lower_limit>
            <ci_upper_limit>0.3838</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1462</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0467</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0635</ci_lower_limit>
            <ci_upper_limit>0.2289</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1680</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0702</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0436</ci_lower_limit>
            <ci_upper_limit>0.2924</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1303</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0830</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0172</ci_lower_limit>
            <ci_upper_limit>0.2778</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1953</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0747</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>0.0625</ci_lower_limit>
            <ci_upper_limit>0.3281</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.5409</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0729</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4110</ci_lower_limit>
            <ci_upper_limit>0.6707</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.5235</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0675</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4032</ci_lower_limit>
            <ci_upper_limit>0.6438</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.3857</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0512</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2944</ci_lower_limit>
            <ci_upper_limit>0.4769</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.0216</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0368</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0439</ci_lower_limit>
            <ci_upper_limit>0.0872</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1708</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0486</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0841</ci_lower_limit>
            <ci_upper_limit>0.2574</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1660</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0377</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0982</ci_lower_limit>
            <ci_upper_limit>0.2338</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.3524</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0477</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2667</ci_lower_limit>
            <ci_upper_limit>0.4380</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.5631</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0724</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4330</ci_lower_limit>
            <ci_upper_limit>0.6932</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.5807</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0700</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4549</ci_lower_limit>
            <ci_upper_limit>0.7065</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.2814</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0627</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1688</ci_lower_limit>
            <ci_upper_limit>0.3940</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1982</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0577</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0945</ci_lower_limit>
            <ci_upper_limit>0.3019</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.1465</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0615</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0361</ci_lower_limit>
            <ci_upper_limit>0.2569</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Follow-up, Day 25-29</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.8565</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.4796</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0017</ci_lower_limit>
            <ci_upper_limit>1.7112</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up</title>
        <time_frame>Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up</title>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
          <units>mcg/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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9604" spread="0.15380"/>
                    <measurement group_id="O2" value="1.0060" spread="0.41079"/>
                    <measurement group_id="O3" value="0.8677" spread="0.18896"/>
                    <measurement group_id="O4" value="0.8922" spread="0.13486"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 1 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2539" spread="0.24173"/>
                    <measurement group_id="O2" value="0.1440" spread="0.56564"/>
                    <measurement group_id="O3" value="-0.1205" spread="0.16427"/>
                    <measurement group_id="O4" value="0.0847" spread="0.41097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 2 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2229" spread="0.08132"/>
                    <measurement group_id="O2" value="0.2130" spread="0.40812"/>
                    <measurement group_id="O3" value="-0.0145" spread="0.13714"/>
                    <measurement group_id="O4" value="-0.0421" spread="0.21113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 4 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2774" spread="0.19696"/>
                    <measurement group_id="O2" value="0.0717" spread="0.62608"/>
                    <measurement group_id="O3" value="-0.1426" spread="0.14932"/>
                    <measurement group_id="O4" value="-0.0369" spread="0.32185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 8 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2000" spread="0.27433"/>
                    <measurement group_id="O2" value="0.1760" spread="0.78402"/>
                    <measurement group_id="O3" value="-0.1895" spread="0.18641"/>
                    <measurement group_id="O4" value="-0.1870" spread="0.26137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 12 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2973" spread="0.13666"/>
                    <measurement group_id="O2" value="0.2703" spread="0.62935"/>
                    <measurement group_id="O3" value="-0.0979" spread="0.15883"/>
                    <measurement group_id="O4" value="-0.0967" spread="0.22579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, Hour 24 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0937" spread="0.30529"/>
                    <measurement group_id="O2" value="0.5607" spread="0.66507"/>
                    <measurement group_id="O3" value="-0.0039" spread="0.10751"/>
                    <measurement group_id="O4" value="0.1200" spread="0.48900"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, pre-dose (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1309" spread="0.31653"/>
                    <measurement group_id="O2" value="0.0810" spread="0.21355"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.1317" spread="0.57974"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 1 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1089" spread="0.40558"/>
                    <measurement group_id="O2" value="-0.1575" spread="0.46598"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0285" spread="0.43096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 2 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0923" spread="0.11659"/>
                    <measurement group_id="O2" value="0.1360" spread="0.67317"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0103" spread="0.35162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 4 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0067" spread="0.28262"/>
                    <measurement group_id="O2" value="-0.2505" spread="0.37406"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.0762" spread="0.37371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 8 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2610" spread="0.30443"/>
                    <measurement group_id="O2" value="-0.0495" spread="0.61023"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0543" spread="0.35172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 12 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2860" spread="0.21522"/>
                    <measurement group_id="O2" value="-0.5290" spread="0.32951"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.1557" spread="0.15279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7, Hour 24 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1926" spread="0.18082"/>
                    <measurement group_id="O2" value="0.1410" spread="0.68024"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0680" spread="0.35421"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, pre-dose (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2573" spread="0.23823"/>
                    <measurement group_id="O2" value="0.0710" spread="0.24183"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0978" spread="0.10319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 1 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2292" spread="0.13816"/>
                    <measurement group_id="O2" value="0.1660" spread="0.30547"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.1065" spread="0.19276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 2 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1970" spread="0.20110"/>
                    <measurement group_id="O2" value="0.2860" spread="0.29133"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.0047" spread="0.25228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 4 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3627" spread="0.22065"/>
                    <measurement group_id="O2" value="0.1210" spread="0.42568"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.0133" spread="0.30407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 8 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2898" spread="0.32120"/>
                    <measurement group_id="O2" value="-0.2310" spread="0.16829"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.0698" spread="0.34513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 12 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2415" spread="0.19015"/>
                    <measurement group_id="O2" value="0.0510" spread="0.11455"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.1075" spread="0.20019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14, Hour 24 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2030" spread="0.23638"/>
                    <measurement group_id="O2" value="0.2260" spread="0.36204"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.0855" spread="0.36310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up Day 25-29 (n=6,3,10,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0965" spread="0.43007"/>
                    <measurement group_id="O2" value="-0.2550" spread="0.91149"/>
                    <measurement group_id="O3" value="0.3204" spread="0.30373"/>
                    <measurement group_id="O4" value="0.3778" spread="0.73741"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.348</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.209</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.707</ci_lower_limit>
            <ci_upper_limit>0.010</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.179</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.205</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.533</ci_lower_limit>
            <ci_upper_limit>0.175</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.258</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.180</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.568</ci_lower_limit>
            <ci_upper_limit>0.052</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.046</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.201</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-0.390</ci_lower_limit>
            <ci_upper_limit>0.298</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.284</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.168</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_lower_limit>-0.575</ci_lower_limit>
            <ci_upper_limit>0.006</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.166</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.235</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.569</ci_lower_limit>
            <ci_upper_limit>0.237</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.263</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.230</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.657</ci_lower_limit>
            <ci_upper_limit>0.132</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.080</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.221</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.460</ci_lower_limit>
            <ci_upper_limit>0.299</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.082</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.180</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.392</ci_lower_limit>
            <ci_upper_limit>0.228</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.083</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.189</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.408</ci_lower_limit>
            <ci_upper_limit>0.242</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.207</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.174</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.508</ci_lower_limit>
            <ci_upper_limit>0.095</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.130</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.186</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.451</ci_lower_limit>
            <ci_upper_limit>0.191</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.125</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.186</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.445</ci_lower_limit>
            <ci_upper_limit>0.196</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.188</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.162</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.472</ci_lower_limit>
            <ci_upper_limit>0.097</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.152</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.161</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.434</ci_lower_limit>
            <ci_upper_limit>0.130</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.231</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.155</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.504</ci_lower_limit>
            <ci_upper_limit>0.043</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.405</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.184</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.722</ci_lower_limit>
            <ci_upper_limit>-0.088</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.249</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.180</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.560</ci_lower_limit>
            <ci_upper_limit>0.062</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.163</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.176</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.467</ci_lower_limit>
            <ci_upper_limit>0.141</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.317</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.183</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.633</ci_lower_limit>
            <ci_upper_limit>-0.002</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Follow-up, Day 25-29</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.094</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.339</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.683</ci_lower_limit>
            <ci_upper_limit>0.496</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.050</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.266</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.406</ci_lower_limit>
            <ci_upper_limit>0.505</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.257</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.260</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.193</ci_lower_limit>
            <ci_upper_limit>0.707</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.091</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.229</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.302</ci_lower_limit>
            <ci_upper_limit>0.485</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.330</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.256</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.107</ci_lower_limit>
            <ci_upper_limit>0.768</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.283</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.214</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.087</ci_lower_limit>
            <ci_upper_limit>0.653</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.488</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.299</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.024</ci_lower_limit>
            <ci_upper_limit>1.000</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.206</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.327</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.356</ci_lower_limit>
            <ci_upper_limit>0.768</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.123</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.310</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.410</ci_lower_limit>
            <ci_upper_limit>0.656</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.396</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.246</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.025</ci_lower_limit>
            <ci_upper_limit>0.818</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.077</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.260</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.523</ci_lower_limit>
            <ci_upper_limit>0.368</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.254</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.237</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.154</ci_lower_limit>
            <ci_upper_limit>0.661</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.125</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.256</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.564</ci_lower_limit>
            <ci_upper_limit>0.315</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.458</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.256</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.019</ci_lower_limit>
            <ci_upper_limit>0.897</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, pre-dose</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.418</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.215</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.043</ci_lower_limit>
            <ci_upper_limit>0.792</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.521</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.213</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.150</ci_lower_limit>
            <ci_upper_limit>0.893</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 2</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.530</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.204</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.172</ci_lower_limit>
            <ci_upper_limit>0.888</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 4</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.357</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.247</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.069</ci_lower_limit>
            <ci_upper_limit>0.782</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 8</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.088</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.242</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.328</ci_lower_limit>
            <ci_upper_limit>0.503</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 12</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.406</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.236</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.000</ci_lower_limit>
            <ci_upper_limit>0.812</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14, Hour 24</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.377</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.247</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.047</ci_lower_limit>
            <ci_upper_limit>0.802</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Follow-up, Day 25-29</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.223</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.418</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.949</ci_lower_limit>
            <ci_upper_limit>0.502</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14</title>
        <description>Change from baseline in urinary uric acid cumulative amounts.</description>
        <time_frame>Baseline, Day 1, Day 7 and Day 14</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14</title>
          <description>Change from baseline in urinary uric acid cumulative amounts.</description>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective 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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="658.495" spread="192.7457"/>
                    <measurement group_id="O2" value="745.574" spread="262.1465"/>
                    <measurement group_id="O3" value="590.951" spread="195.9763"/>
                    <measurement group_id="O4" value="583.854" spread="147.2471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 1 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="308.363" spread="320.3229"/>
                    <measurement group_id="O2" value="424.684" spread="475.6851"/>
                    <measurement group_id="O3" value="168.996" spread="339.0577"/>
                    <measurement group_id="O4" value="-19.228" spread="117.2680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 7 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.603" spread="160.1758"/>
                    <measurement group_id="O2" value="-28.477" spread="235.2700"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-23.369" spread="141.1305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 14 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.610" spread="236.5787"/>
                    <measurement group_id="O2" value="-79.793" spread="195.2251"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-34.863" spread="81.4321"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>316.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>166.57</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.91</ci_lower_limit>
            <ci_upper_limit>611.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>61.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>88.27</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-94.87</ci_lower_limit>
            <ci_upper_limit>218.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>107.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>100.38</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-71.20</ci_lower_limit>
            <ci_upper_limit>287.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>433.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>211.71</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>58.30</ci_lower_limit>
            <ci_upper_limit>808.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>13.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>125.47</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-208.07</ci_lower_limit>
            <ci_upper_limit>234.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>-29.83</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>142.95</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-285.26</ci_lower_limit>
            <ci_upper_limit>225.60</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14</title>
        <description>Change from baseline in urinary xanthine cumulative amounts.</description>
        <time_frame>Baseline, Day 1, Day 7 and Day 14</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14</title>
          <description>Change from baseline in urinary xanthine cumulative amounts.</description>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective 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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.014" spread="1.9431"/>
                    <measurement group_id="O2" value="8.783" spread="2.2772"/>
                    <measurement group_id="O3" value="5.756" spread="2.3429"/>
                    <measurement group_id="O4" value="6.431" spread="2.4413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 1 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.528" spread="2.6662"/>
                    <measurement group_id="O2" value="13.209" spread="4.8900"/>
                    <measurement group_id="O3" value="1.793" spread="2.2691"/>
                    <measurement group_id="O4" value="0.031" spread="0.8807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 7 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.838" spread="1.8937"/>
                    <measurement group_id="O2" value="27.886" spread="1.1209"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.832" spread="1.3666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 14 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.291" spread="2.1068"/>
                    <measurement group_id="O2" value="29.063" spread="2.9613"/>
                    <measurement group_id="O3" value="NA" spread="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="-0.708" spread="0.7644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>3.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.57</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>6.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>3.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.94</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.97</ci_lower_limit>
            <ci_upper_limit>5.37</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>8.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.24</ci_lower_limit>
            <ci_upper_limit>9.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>13.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.00</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.65</ci_lower_limit>
            <ci_upper_limit>16.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>27.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.40</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.49</ci_lower_limit>
            <ci_upper_limit>30.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>28.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.48</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>26.14</ci_lower_limit>
            <ci_upper_limit>31.41</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14</title>
        <description>Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14</description>
        <time_frame>Baseline, Day 1, Day 7 and Day 14</time_frame>
        <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
            <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: PF-06743649 40 mg</title>
            <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: PF-06743649 5 mg</title>
            <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 and 2: Placebo</title>
            <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14</title>
          <description>Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14</description>
          <population>The full analysis population included all participants randomized and who received at least 1 dose of randomization treatment; n=number of participants analyzed in each respective 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="7"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.999" spread="2.4371"/>
                    <measurement group_id="O2" value="7.732" spread="1.5422"/>
                    <measurement group_id="O3" value="5.416" spread="2.3568"/>
                    <measurement group_id="O4" value="5.500" spread="1.9022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 1 (n=7,3,11,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.435" spread="2.1850" lower_limit="0.94" upper_limit="3.93"/>
                    <measurement group_id="O2" value="3.051" spread="2.5346" lower_limit="0.76" upper_limit="5.34"/>
                    <measurement group_id="O3" value="1.600" spread="3.2414"/>
                    <measurement group_id="O4" value="1.486" spread="2.1230" lower_limit="-0.08" upper_limit="3.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 7 (n=7,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.295" spread="3.1395" lower_limit="1.80" upper_limit="4.79"/>
                    <measurement group_id="O2" value="8.714" spread="0.2294" lower_limit="5.40" upper_limit="10.83"/>
                    <measurement group_id="O3" value="NA" spread="NA" lower_limit="NA" upper_limit="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.384" spread="0.9645" lower_limit="-1.23" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 14 (n=6,2,0,6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.291" spread="3.2263" lower_limit="2.88" upper_limit="6.05"/>
                    <measurement group_id="O2" value="10.536" spread="0.9138" lower_limit="7.22" upper_limit="12.66"/>
                    <measurement group_id="O3" value="NA" spread="NA" lower_limit="NA" upper_limit="NA">No data due to cohort termination after 2 days of dosing.</measurement>
                    <measurement group_id="O4" value="0.870" spread="0.8776" lower_limit="-0.75" upper_limit="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>0.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.29</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.31</ci_lower_limit>
            <ci_upper_limit>3.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>2.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.29</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>5.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>3.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.33</dispersion_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>5.85</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>1.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.64</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>4.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 7</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>7.73</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.86</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.57</ci_lower_limit>
            <ci_upper_limit>10.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Day 14</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>LS Mean Difference</param_type>
            <param_value>9.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.86</dispersion_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.91</ci_lower_limit>
            <ci_upper_limit>12.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 28 days after last study drug administration.</time_frame>
      <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 1 participant and as nonserious in another, or 1 participant may have experienced both an AE and SAE during the study. All treated participants were included in the analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: PF-06743649 2.5 mg to 10 mg</title>
          <description>Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 1: PF-06743649 40 mg</title>
          <description>Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 2: PF-06743649 5 mg</title>
          <description>Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 1 and 2: Placebo</title>
          <description>Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Cystatin C increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </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="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="9"/>
              </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/NCT02187029
org study id: B7911002
nct id: NCT02187029
lead sponsor: 
has dmc: No
The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid
      in subjects suffering from gout following 14 days of dosing, as well as assessing safety and
      tolerability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Baseline of Serum Uric Acid
time frame: Baseline (pre-dose Day 1)
description: An elevation in serum uric acid, hyperuricemia, is a prerequisite for the development of gout.
measure: Percent Change From Baseline in Serum Uric Acid Level at 24 Hours Post Dose on Day 14
time frame: Day 14 Hour 24
measure: Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 28 days after last study drug administration (Day 42)
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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/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 pre-treatment state AEs included both serious and non-serious events.
measure: Number of Participants With Laboratory Test Abnormalities
time frame: Baseline up to follow up visit (Day 25-29)
description: Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters include hematology (Hemoglobin, Hematocrit, red blood cell [RBC] count, Platelet count, mean corpuscular volume [MCV], mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration [MCHC], white blood cell [WBC] count, Total neutrophils, Eosinophils, Monocytes, Basophils, Lymphocytes), hematocrit (blood urea nitrogen [BUN]/urea and Creatinine, Glucose , Calcium, Sodium, Potassium, Chloride, Total CO2 [Bicarbonate], aspartate transaminase [AST], alanine transaminase [ALT], Total Bilirubin, Alkaline phosphatase, Albumin, Total protein, Thyroid Stimulating Hormone [TSH], free T3 [FT3] and free T4 [FT4] ), urinalysis (pH, Glucose [qual], Protein, Blood, Ketones, Nitrites, Leukocyte esterase, Urobilinogen, Urine bilirubin, Microscopy [including crystals]) and other (follicle-stimulating hormone [FSH], Urine drug screen).
measure: Number of Participants With Potentially Clinically Significant Vital Signs Findings
time frame: Baseline up to follow up visit (Day 25-29)
description: Criteria for potential clinically important change in vital signs included: Systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg) or more than or equal to (>=)30 mmHg change from baseline, diastolic BP of <50 mmHg or >=20 mmHg change from baseline, Supine pulse rate of <40 or more than (>)120 beats per minute (bpm).
measure: Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
time frame: Baseline up to Day 16
description: Criteria for potential clinically important changes in ECG (12-lead) were defined as: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval) >=300 milliseconds (msec) or increase from baseline >=25% when baseline >200 msec or increase from baseline >=50% when baseline less than or equal to (<=) 200 msec; time from the beginning of the electrocardiogram Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval >=140 msec or >=50% increase from baseline; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval corrected using the Fridericia formula (QTcF) of 450 to < 480 msec, 480 to <500 msec and >=500 msec, or an increase of 30 to <60 msec or >=60 msec from baseline.
measure: Change From Baseline in Serum Uric Acid Levels at Day 1, Day 3, Day 7, Day 11, Day 14 and Follow-up
time frame: Day 1, Day 3, Day 7, Day 11, Day 14 and follow-up visit (Day 25-29)
measure: Number of Participants Reaching Serum Uric Acid Levels <6, <5 and <4 mg/dL at 24 Hours Post Dose on Day 7 and Day 14
time frame: 24 hours post dose on Day 7 and Day 14
description: Number of participants reaching serum uric acid levels <6, <5 and <4 mg/dL at 7 and 14 days after initiation.
measure: Incidence and Severity of Gout Flare Attacks
time frame: Baseline up to Day 42
measure: Duration of Gout Flare Attacks
time frame: Baseline up to Day 42
description: Duration of gout flare attacks with participants who developed gout flare attacks.
measure: Plasma Levels of PF-06743649 After Initiation of Dosing at Day 1, Day 7, and Day 14
time frame: 0, 1, 2, 4, 8, 12 and 24 hours at Day 1, Day 7, and Day 14
description: Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 10.0 nanograms per milliliter (ng/mL).
measure: Plasma Levels of PF-06743648 After Initiation of Dosing at Day 1, Day 7, and Day 14
time frame: Day 1, Day 7, and Day 14
description: PF-06743648 is an active metabolite of PF-06743649. Data has been calculated by setting concentration values below the lower limit of quantification to zero. The lower limit of quantification was 2.00 nanograms per milliliter (ng/mL).
measure: Change From Baseline in Plasma Levels of Xanthine at Day 1, Day 7, Day 14, and at Follow-up
time frame: Baseline, Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
description: Change in plasma levels of xanthine from baseline at time points 0 (prior to dosing except on Day 1), 1, 2, 4, 8, 12 and 24 hours following dosing with PF-06743649 or placebo on days 1, 7 and 14 as well prior to dosing on days 3 and 11 and at follow-up of treatment with PF-06743649 or placebo.
measure: Change From Baseline in Plasma Levels of Hypoxanthine at Day 1, Day 7, Day 14, and at Follow-up
time frame: Day 1, Day 7, Day 14, and at follow-up visit (Day 25-29)
measure: Change From Baseline in Urinary Uric Acid Levels at Day 1, Day 7, and Day 14
time frame: Baseline, Day 1, Day 7 and Day 14
description: Change from baseline in urinary uric acid cumulative amounts.
measure: Change From Baseline in Urinary Xanthine Levels at Day 1, Day 7, and Day 14
time frame: Baseline, Day 1, Day 7 and Day 14
description: Change from baseline in urinary xanthine cumulative amounts.
measure: Change From Baseline in Urinary Hypoxanthine Levels at Day 1, Day 7, and Day 14
time frame: Baseline, Day 1, Day 7 and Day 14
description: Change from baseline in urinary hypoxanthine cumulative amounts at Day 1, Day 7 and Day 14
arm group label: PF-06743649 dose level 1 (Cohort 1)
arm group type: Experimental
arm group label: Placebo for PF-06743649 (Cohort 1)
arm group type: Placebo Comparator
arm group label: PF-06743649 dose level 2 (Cohort 2)
arm group type: Experimental
arm group label: Placebo for PF-06743649 (Cohort 2)
arm group type: Placebo Comparator
intervention type: Drug
intervention name: PF-06743649
description: Daily dosing (dose level 1) tablet for 14 days
arm group label: PF-06743649 dose level 1 (Cohort 1)
intervention type: Other
intervention name: Placebo
description: Daily dosing (tablet) for 14 days
arm group label: Placebo for PF-06743649 (Cohort 1)
intervention type: Drug
intervention name: PF-06743649
description: Daily dosing (dose level 2) tablet(s) for 14 days
arm group label: PF-06743649 dose level 2 (Cohort 2)
intervention type: Other
intervention name: Placebo
description: Daily dosing (tablets) for 14 days
arm group label: Placebo for PF-06743649 (Cohort 2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7911002&StudyName=Efficacy%2C%20Safety%20And%20Tolerability%20Of%20PF-06743649%20In%20Gout%20Subjects.%0A
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Gout
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 