<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/NCT01673178</url>
  </required_header>
  <id_info>
    <org_study_id>B2901011</org_study_id>
    <nct_id>NCT01673178</nct_id>
  </id_info>
  <brief_title>Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus</brief_title>
  <official_title>A Phase 1, Placebo-controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Iv Doses Of Pf-05231023 In Obese Hyperlipidemic Adult Subjects With And Without Type 2 Diabetes Mellitus On A Background Of Atorvastatin</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>
      This is a trial in obese subjects who have poor lipid control with and without Type 2&#xD;
      diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of&#xD;
      PF-05231023&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <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 dose</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 events were 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Baseline up to Day 49</time_frame>
    <description>Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [&lt;]0.8*lower limit of normal [LLN], platelets: &lt;0.5*LLN/greater than [&gt;]1.75*upper limit of normal [ULN], leukocytes: &lt;0.6*LLN or &gt;1.5*ULN, lymphocytes, total neutrophils: &lt;0.8*LLN or &gt;1.2*ULN, basophils, eosinophil: &lt;0.8*LLN, monocytes: &gt;1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: &gt;0.3*ULN, total protein, albumin: &lt;0.8*LLN or &gt;1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: &gt;1.5*ULN; Renal Function (blood urea nitrogen, creatinine: &gt;1.3*ULN, uric acid: &gt;1.2*ULN); Electrolytes (sodium: &lt;0.95*LLN or &gt;1.05*ULN, potassium, chloride, calcium, bicarbonate: &lt;0.9*LLN or &gt;1.1*ULN; creatine kinase: &gt;2.0*ULN; glucose fasting: &lt;0.6*LLN or &gt;1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (&gt;=) 20/High Power Field [HPF]).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Vital Sign Abnormalities</measure>
    <time_frame>Baseline up to Day 49</time_frame>
    <description>Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of &lt;40 beats per minute (bpm) or &gt;120 bpm, supine systolic blood pressure (SBP) of &lt;90 millimeter of mercury (mmHg), &gt;=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of &lt;50 mmHg; &gt;=20 mmHg maximum increase and decrease from baseline in same posture.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Electrocardiogram Findings</measure>
    <time_frame>Baseline up to Day 49</time_frame>
    <description>Clinically significant ECG findings included PR interval &gt;=300 milliseconds (msec) or &gt;=25 percent (%) increase from baseline (if baseline PR interval &gt;200 msec) or &gt;=50% increase (if baseline PR interval less than or equal to [&lt;=] 200 msec); QRS interval &gt;=140 msec or &gt;=50% increase from baseline; QT interval &gt;=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to &lt;480 msec, 480 to &lt;500 msec, &gt;=500 msec or &gt;=30 msec but &lt;60 msec increase from baseline or &gt;=60 msec increase from baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Physical Examinations</measure>
    <time_frame>Baseline up to Day 49</time_frame>
    <description>Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thyroid Stimulating Hormone (TSH) Level at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Results are reported in micro international units per milliliter (mcIU/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thyroid Stimulating Hormone (TSH) Level at Day 1</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Thyroid Stimulating Hormone (TSH) Level at Day 25</measure>
    <time_frame>Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Thyroid Stimulating Hormone (TSH) Level at Day 39</measure>
    <time_frame>Day 39</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Thyroid Stimulating Hormone (TSH) Level at Day 49</measure>
    <time_frame>Day 49</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phosphate Level at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Phosphate Level at Day 8</measure>
    <time_frame>Baseline, Day 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Phosphate Level at Day 15</measure>
    <time_frame>Baseline, Day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Phosphate Level at Day 25</measure>
    <time_frame>Baseline, Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Phosphate Level at Day 49</measure>
    <time_frame>Baseline, Day 49</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Creatine Phosphokinase (CPK) Level at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8</measure>
    <time_frame>Baseline, Day 8</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15</measure>
    <time_frame>Baseline, Day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25</measure>
    <time_frame>Baseline, Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49</measure>
    <time_frame>Baseline, Day 49</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25</measure>
    <time_frame>Baseline, Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39</measure>
    <time_frame>Baseline, Day 39</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49</measure>
    <time_frame>Baseline, Day 49</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25</measure>
    <time_frame>Baseline, Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39</measure>
    <time_frame>Baseline, Day 39</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49</measure>
    <time_frame>Baseline, Day 49</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25</measure>
    <time_frame>Baseline, Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39</measure>
    <time_frame>Baseline, Day 39</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49</measure>
    <time_frame>Day 49</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24</measure>
    <time_frame>Day 24</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1</measure>
    <time_frame>Day 1</time_frame>
    <description>Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39</measure>
    <time_frame>Day 39</time_frame>
    <description>Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49</measure>
    <time_frame>Day 49</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8</time_frame>
    <description>AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8</time_frame>
    <description>Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8</time_frame>
    <description>Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29</time_frame>
    <description>AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
    <description>Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
    <description>Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29</time_frame>
    <description>Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023</measure>
    <time_frame>0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49</time_frame>
    <description>Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
    <description>Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
    <description>Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Decay Half-Life (t1/2) of PF-05231023</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearance (CL) of PF-05231023</measure>
    <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
    <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Diabetes Melliuts, Type 2</condition>
  <arm_group>
    <arm_group_label>Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>150 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks</description>
    <arm_group_label>Placebo Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>25 mg PF-05231023</intervention_name>
    <description>25 mg IV once a week for 4 weeks</description>
    <arm_group_label>25 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>50 mg PF-05231023</intervention_name>
    <description>50 mg IV once a week for 4 weeks</description>
    <arm_group_label>50 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>100 mg PF-05231023</intervention_name>
    <description>100 mg IV once a week for 4 weeks</description>
    <arm_group_label>100 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>150 mg PF-05231023</intervention_name>
    <description>150 mg IV once a week for 4 weeks</description>
    <arm_group_label>150 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects of non-childbearing potential between the ages of 30 and 70&#xD;
             years with and without a diagnosis of Type 2 diabetes mellitus (according to the&#xD;
             American Diabetes Association guidelines).&#xD;
&#xD;
          -  Subjects with poor lipid control as confirmed by laboratory tests.&#xD;
&#xD;
          -  BMI of 30 to 40 Kg/m2 and a total body weight of &gt;50 kg (110 lbs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic disease (including drug allergies, but excluding asymptomatic, seasonal&#xD;
             allergies at time of dosing).&#xD;
&#xD;
          -  Levels of blood enzymes indicating pancreatitis or elevated liver function enzymes&#xD;
             outside of the laboratory's reference range as confirmed by laboratory tests.&#xD;
&#xD;
          -  Subjects with Type 1 Diabetes Mellitus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 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>Anaheim Clinical Trials, LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Profil Institute for Clinical Research, Inc.</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diablo Clinical Research, Inc.</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33169</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>MRA Clinical Research, LLC</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates, Inc.</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L-MARC Research Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prism Research</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Clinical Trials Center, LLC</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Phase 1 Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Internal Medicine Consultants</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medpace Clinical Pharmacology Unit</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Pharmacy</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</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=B2901011&amp;StudyName=Multiple%20Dose%20Study%20Of%20PF-05231023%20In%20Adult%20Subjects%20Who%20Have%20Poor%20Lipid%20Control%20With%20And%20Without%20Type%202%20Diabetes%20Mellitus</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>January 6, 2015</results_first_submitted>
  <results_first_submitted_qc>January 6, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 14, 2015</results_first_posted>
  <last_update_submitted>January 28, 2015</last_update_submitted>
  <last_update_submitted_qc>January 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Type 2 diabetes</keyword>
  <keyword>safety</keyword>
  <keyword>multiple dose</keyword>
  <keyword>intravenous</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="P2">
          <title>PF-05231023 25 mg</title>
          <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="P3">
          <title>PF-05231023 50 mg</title>
          <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="P4">
          <title>PF-05231023 100 mg</title>
          <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="P5">
          <title>PF-05231023 150 mg</title>
          <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</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="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis set included all participants who received at least 1 dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="B2">
          <title>PF-05231023 25 mg</title>
          <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="B3">
          <title>PF-05231023 50 mg</title>
          <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="B4">
          <title>PF-05231023 100 mg</title>
          <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="B5">
          <title>PF-05231023 150 mg</title>
          <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="B6">
          <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="22"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="21"/>
            <count group_id="B4" value="22"/>
            <count group_id="B5" value="21"/>
            <count group_id="B6" value="107"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.8" spread="8.0"/>
                    <measurement group_id="B2" value="54.6" spread="8.3"/>
                    <measurement group_id="B3" value="53.4" spread="9.5"/>
                    <measurement group_id="B4" value="53.0" spread="7.4"/>
                    <measurement group_id="B5" value="53.2" spread="8.0"/>
                    <measurement group_id="B6" value="53.4" spread="8.1"/>
                  </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="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <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 events were 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.</description>
        <time_frame>Baseline up to 28 days after last dose</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</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 events were 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.</description>
          <population>Safety analysis set 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="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [&lt;]0.8*lower limit of normal [LLN], platelets: &lt;0.5*LLN/greater than [&gt;]1.75*upper limit of normal [ULN], leukocytes: &lt;0.6*LLN or &gt;1.5*ULN, lymphocytes, total neutrophils: &lt;0.8*LLN or &gt;1.2*ULN, basophils, eosinophil: &lt;0.8*LLN, monocytes: &gt;1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: &gt;0.3*ULN, total protein, albumin: &lt;0.8*LLN or &gt;1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: &gt;1.5*ULN; Renal Function (blood urea nitrogen, creatinine: &gt;1.3*ULN, uric acid: &gt;1.2*ULN); Electrolytes (sodium: &lt;0.95*LLN or &gt;1.05*ULN, potassium, chloride, calcium, bicarbonate: &lt;0.9*LLN or &gt;1.1*ULN; creatine kinase: &gt;2.0*ULN; glucose fasting: &lt;0.6*LLN or &gt;1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (&gt;=) 20/High Power Field [HPF]).</description>
        <time_frame>Baseline up to Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [&lt;]0.8*lower limit of normal [LLN], platelets: &lt;0.5*LLN/greater than [&gt;]1.75*upper limit of normal [ULN], leukocytes: &lt;0.6*LLN or &gt;1.5*ULN, lymphocytes, total neutrophils: &lt;0.8*LLN or &gt;1.2*ULN, basophils, eosinophil: &lt;0.8*LLN, monocytes: &gt;1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: &gt;0.3*ULN, total protein, albumin: &lt;0.8*LLN or &gt;1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: &gt;1.5*ULN; Renal Function (blood urea nitrogen, creatinine: &gt;1.3*ULN, uric acid: &gt;1.2*ULN); Electrolytes (sodium: &lt;0.95*LLN or &gt;1.05*ULN, potassium, chloride, calcium, bicarbonate: &lt;0.9*LLN or &gt;1.1*ULN; creatine kinase: &gt;2.0*ULN; glucose fasting: &lt;0.6*LLN or &gt;1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (&gt;=) 20/High Power Field [HPF]).</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="20"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="17"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Vital Sign Abnormalities</title>
        <description>Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of &lt;40 beats per minute (bpm) or &gt;120 bpm, supine systolic blood pressure (SBP) of &lt;90 millimeter of mercury (mmHg), &gt;=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of &lt;50 mmHg; &gt;=20 mmHg maximum increase and decrease from baseline in same posture.</description>
        <time_frame>Baseline up to Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Vital Sign Abnormalities</title>
          <description>Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of &lt;40 beats per minute (bpm) or &gt;120 bpm, supine systolic blood pressure (SBP) of &lt;90 millimeter of mercury (mmHg), &gt;=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of &lt;50 mmHg; &gt;=20 mmHg maximum increase and decrease from baseline in same posture.</description>
          <population>Safety analysis set 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="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Supine SBP: &lt;90 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine DBP: &lt;50 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Increase in Supine SBP: &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Increase in Supine DBP: &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Decrease in Supine SBP: &gt;=30 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum Decrease in Supine DBP: &gt;=20 mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Pulse Rate: &lt;40 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Supine Pulse Rate: &gt;120 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Electrocardiogram Findings</title>
        <description>Clinically significant ECG findings included PR interval &gt;=300 milliseconds (msec) or &gt;=25 percent (%) increase from baseline (if baseline PR interval &gt;200 msec) or &gt;=50% increase (if baseline PR interval less than or equal to [&lt;=] 200 msec); QRS interval &gt;=140 msec or &gt;=50% increase from baseline; QT interval &gt;=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to &lt;480 msec, 480 to &lt;500 msec, &gt;=500 msec or &gt;=30 msec but &lt;60 msec increase from baseline or &gt;=60 msec increase from baseline.</description>
        <time_frame>Baseline up to Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Electrocardiogram Findings</title>
          <description>Clinically significant ECG findings included PR interval &gt;=300 milliseconds (msec) or &gt;=25 percent (%) increase from baseline (if baseline PR interval &gt;200 msec) or &gt;=50% increase (if baseline PR interval less than or equal to [&lt;=] 200 msec); QRS interval &gt;=140 msec or &gt;=50% increase from baseline; QT interval &gt;=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to &lt;480 msec, 480 to &lt;500 msec, &gt;=500 msec or &gt;=30 msec but &lt;60 msec increase from baseline or &gt;=60 msec increase from baseline.</description>
          <population>Safety analysis set 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="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maximum PR interval: &gt;=300 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum PR interval increase : 25% or 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QRS complex: &gt;=140 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QT interval: &gt;=500 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTcF interval: 450-&lt;480 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTcF interval: 480-&lt;500 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTcF interval: &gt;=500 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTcF interval increase: &gt;= 30 to &lt;60 msec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum QTCF interval increase: &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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Physical Examinations</title>
        <description>Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.</description>
        <time_frame>Baseline up to Day 49</time_frame>
        <population>Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Physical Examinations</title>
          <description>Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.</description>
          <population>Physical examination data reported in this study was for identification of adverse events and were reported as an adverse event in the adverse event section.</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 group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Thyroid Stimulating Hormone (TSH) Level at Baseline</title>
        <description>Results are reported in micro international units per milliliter (mcIU/mL).</description>
        <time_frame>Baseline</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Thyroid Stimulating Hormone (TSH) Level at Baseline</title>
          <description>Results are reported in micro international units per milliliter (mcIU/mL).</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication.</population>
          <units>mcIU/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="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.65"/>
                    <measurement group_id="O2" value="2.14" spread="1.25"/>
                    <measurement group_id="O3" value="1.96" spread="1.06"/>
                    <measurement group_id="O4" value="1.88" spread="1.02"/>
                    <measurement group_id="O5" value="2.06" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Thyroid Stimulating Hormone (TSH) Level at Day 1</title>
        <time_frame>Day 1</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Thyroid Stimulating Hormone (TSH) Level at Day 1</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mcIU/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="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.96" spread="0.95"/>
                    <measurement group_id="O2" value="2.19" spread="1.10"/>
                    <measurement group_id="O3" value="2.40" spread="1.40"/>
                    <measurement group_id="O4" value="2.26" spread="1.27"/>
                    <measurement group_id="O5" value="4.21" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Thyroid Stimulating Hormone (TSH) Level at Day 25</title>
        <time_frame>Day 25</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Thyroid Stimulating Hormone (TSH) Level at Day 25</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mcIU/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="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.70" spread="3.68"/>
                    <measurement group_id="O2" value="2.13" spread="1.07"/>
                    <measurement group_id="O3" value="2.43" spread="0.87"/>
                    <measurement group_id="O4" value="2.52" spread="1.38"/>
                    <measurement group_id="O5" value="4.06" spread="5.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Thyroid Stimulating Hormone (TSH) Level at Day 39</title>
        <time_frame>Day 39</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Thyroid Stimulating Hormone (TSH) Level at Day 39</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mcIU/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="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="8.11"/>
                    <measurement group_id="O2" value="2.08" spread="1.54"/>
                    <measurement group_id="O3" value="2.17" spread="1.12"/>
                    <measurement group_id="O4" value="2.50" spread="1.37"/>
                    <measurement group_id="O5" value="3.10" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Thyroid Stimulating Hormone (TSH) Level at Day 49</title>
        <time_frame>Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Thyroid Stimulating Hormone (TSH) Level at Day 49</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mcIU/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="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.42" spread="7.45"/>
                    <measurement group_id="O2" value="1.98" spread="1.16"/>
                    <measurement group_id="O3" value="2.43" spread="1.78"/>
                    <measurement group_id="O4" value="2.55" spread="1.06"/>
                    <measurement group_id="O5" value="3.10" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phosphate Level at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Phosphate Level at Baseline</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>milligram per deciliter (mg/dL)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="3.0" upper_limit="5.1"/>
                    <measurement group_id="O2" value="3.8" lower_limit="3.1" upper_limit="5.0"/>
                    <measurement group_id="O3" value="3.9" lower_limit="3.0" upper_limit="5.3"/>
                    <measurement group_id="O4" value="4.0" lower_limit="3.0" upper_limit="5.2"/>
                    <measurement group_id="O5" value="4.0" lower_limit="2.9" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Phosphate Level at Day 8</title>
        <time_frame>Baseline, Day 8</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Phosphate Level at Day 8</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-1.4" upper_limit="0.8"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-1.4" upper_limit="0.6"/>
                    <measurement group_id="O3" value="0.1" lower_limit="-0.8" upper_limit="0.6"/>
                    <measurement group_id="O4" value="0.0" lower_limit="-1.0" upper_limit="0.8"/>
                    <measurement group_id="O5" value="-0.3" lower_limit="-1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Phosphate Level at Day 15</title>
        <time_frame>Baseline, Day 15</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Phosphate Level at Day 15</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" lower_limit="-1.2" upper_limit="0.8"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-2.3" upper_limit="0.7"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-1.6" upper_limit="1.3"/>
                    <measurement group_id="O4" value="-0.1" lower_limit="-0.9" upper_limit="0.9"/>
                    <measurement group_id="O5" value="-0.2" lower_limit="-0.8" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Phosphate Level at Day 25</title>
        <time_frame>Baseline, Day 25</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Phosphate Level at Day 25</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" lower_limit="-1.1" upper_limit="0.8"/>
                    <measurement group_id="O2" value="-0.2" lower_limit="-1.1" upper_limit="0.5"/>
                    <measurement group_id="O3" value="0.2" lower_limit="-0.6" upper_limit="1.1"/>
                    <measurement group_id="O4" value="0.1" lower_limit="-0.6" upper_limit="0.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="-0.7" upper_limit="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Phosphate Level at Day 49</title>
        <time_frame>Baseline, Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Phosphate Level at Day 49</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.40" lower_limit="-1.50" upper_limit="0.30"/>
                    <measurement group_id="O2" value="-0.40" lower_limit="-1.40" upper_limit="1.00"/>
                    <measurement group_id="O3" value="-0.20" lower_limit="-1.20" upper_limit="1.20"/>
                    <measurement group_id="O4" value="-0.30" lower_limit="-1.10" upper_limit="0.70"/>
                    <measurement group_id="O5" value="-0.10" lower_limit="-0.90" upper_limit="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Creatine Phosphokinase (CPK) Level at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Creatine Phosphokinase (CPK) Level at Baseline</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>units per liter (U/L)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" lower_limit="26" upper_limit="471"/>
                    <measurement group_id="O2" value="94" lower_limit="42" upper_limit="493"/>
                    <measurement group_id="O3" value="94" lower_limit="38" upper_limit="399"/>
                    <measurement group_id="O4" value="103" lower_limit="45" upper_limit="699"/>
                    <measurement group_id="O5" value="108" lower_limit="44" upper_limit="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8</title>
        <time_frame>Baseline, Day 8</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>U/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="-260" upper_limit="143"/>
                    <measurement group_id="O2" value="32" lower_limit="-21" upper_limit="850"/>
                    <measurement group_id="O3" value="13" lower_limit="-70" upper_limit="245"/>
                    <measurement group_id="O4" value="25" lower_limit="-175" upper_limit="92"/>
                    <measurement group_id="O5" value="13" lower_limit="-27" upper_limit="7614"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15</title>
        <time_frame>Baseline, Day 15</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>U/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="16"/>
                <count group_id="O5" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" lower_limit="-34" upper_limit="852"/>
                    <measurement group_id="O2" value="20" lower_limit="-34" upper_limit="629"/>
                    <measurement group_id="O3" value="7" lower_limit="-97" upper_limit="243"/>
                    <measurement group_id="O4" value="22" lower_limit="-113" upper_limit="238"/>
                    <measurement group_id="O5" value="18" lower_limit="-62" upper_limit="248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25</title>
        <time_frame>Baseline, Day 25</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>U/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5" lower_limit="-246" upper_limit="32"/>
                    <measurement group_id="O2" value="-6" lower_limit="-38" upper_limit="48"/>
                    <measurement group_id="O3" value="-15" lower_limit="-110" upper_limit="19"/>
                    <measurement group_id="O4" value="-8" lower_limit="-54" upper_limit="771"/>
                    <measurement group_id="O5" value="-3" lower_limit="-90" upper_limit="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49</title>
        <time_frame>Baseline, Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>U/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="-141" upper_limit="2214"/>
                    <measurement group_id="O2" value="40" lower_limit="-30" upper_limit="494"/>
                    <measurement group_id="O3" value="27" lower_limit="-85" upper_limit="292"/>
                    <measurement group_id="O4" value="43" lower_limit="-16" upper_limit="216"/>
                    <measurement group_id="O5" value="10" lower_limit="-62" upper_limit="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>nanogram per milliliter (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="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PINP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3" spread="15.6"/>
                    <measurement group_id="O2" value="41.7" spread="17.0"/>
                    <measurement group_id="O3" value="44.7" spread="19.4"/>
                    <measurement group_id="O4" value="45.0" spread="19.8"/>
                    <measurement group_id="O5" value="44.6" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CTX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.11"/>
                    <measurement group_id="O2" value="0.33" spread="0.16"/>
                    <measurement group_id="O3" value="0.35" spread="0.15"/>
                    <measurement group_id="O4" value="0.38" spread="0.20"/>
                    <measurement group_id="O5" value="0.37" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25</title>
        <time_frame>Baseline, Day 25</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PINP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="13.5"/>
                    <measurement group_id="O2" value="-14.5" spread="11.0"/>
                    <measurement group_id="O3" value="-13.4" spread="13.3"/>
                    <measurement group_id="O4" value="-17.6" spread="12.8"/>
                    <measurement group_id="O5" value="-19.8" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CTX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="15.5"/>
                    <measurement group_id="O2" value="2.3" spread="19.7"/>
                    <measurement group_id="O3" value="8.0" spread="23.6"/>
                    <measurement group_id="O4" value="7.3" spread="17.7"/>
                    <measurement group_id="O5" value="7.9" spread="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39</title>
        <time_frame>Baseline, Day 39</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PINP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="13.6"/>
                    <measurement group_id="O2" value="-9.8" spread="12.4"/>
                    <measurement group_id="O3" value="-6.6" spread="15.6"/>
                    <measurement group_id="O4" value="-10.3" spread="12.8"/>
                    <measurement group_id="O5" value="-11.0" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CTX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.3" spread="21.7"/>
                    <measurement group_id="O2" value="-4.2" spread="21.1"/>
                    <measurement group_id="O3" value="-3.5" spread="20.2"/>
                    <measurement group_id="O4" value="-13.1" spread="18.2"/>
                    <measurement group_id="O5" value="-3.0" spread="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49</title>
        <time_frame>Baseline, Day 49</time_frame>
        <population>Safety analysis set included all participants who receive at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49</title>
          <population>Safety analysis set included all participants who receive at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PINP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="16.4"/>
                    <measurement group_id="O2" value="-9.4" spread="16.9"/>
                    <measurement group_id="O3" value="-1.3" spread="20.3"/>
                    <measurement group_id="O4" value="-4.6" spread="15.0"/>
                    <measurement group_id="O5" value="-7.4" spread="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CTX</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="20.8"/>
                    <measurement group_id="O2" value="7.5" spread="30.9"/>
                    <measurement group_id="O3" value="-3.9" spread="33.8"/>
                    <measurement group_id="O4" value="-16.6" spread="15.3"/>
                    <measurement group_id="O5" value="-5.3" spread="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>microgram per liter (mcg/l)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood Osteocalcin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" spread="5.4"/>
                    <measurement group_id="O2" value="19.2" spread="5.9"/>
                    <measurement group_id="O3" value="18.5" spread="6.3"/>
                    <measurement group_id="O4" value="20.2" spread="8.2"/>
                    <measurement group_id="O5" value="19.9" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone-Specific Alkaline Phosphatase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" spread="5.7"/>
                    <measurement group_id="O2" value="11.7" spread="3.9"/>
                    <measurement group_id="O3" value="11.2" spread="4.8"/>
                    <measurement group_id="O4" value="10.0" spread="3.0"/>
                    <measurement group_id="O5" value="11.2" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25</title>
        <time_frame>Baseline, Day 25</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood Osteocalcin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="8.2"/>
                    <measurement group_id="O2" value="-12.2" spread="9.6"/>
                    <measurement group_id="O3" value="-6.4" spread="14.0"/>
                    <measurement group_id="O4" value="-7.1" spread="11.2"/>
                    <measurement group_id="O5" value="-4.8" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone-Specific Alkaline Phosphatase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" spread="14.5"/>
                    <measurement group_id="O2" value="-6.6" spread="17.0"/>
                    <measurement group_id="O3" value="-0.4" spread="15.4"/>
                    <measurement group_id="O4" value="-5.1" spread="16.2"/>
                    <measurement group_id="O5" value="-7.1" spread="13.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39</title>
        <time_frame>Baseline, Day 39</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood Osteocalcin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="12.6"/>
                    <measurement group_id="O2" value="-10.7" spread="9.1"/>
                    <measurement group_id="O3" value="-11.6" spread="12.4"/>
                    <measurement group_id="O4" value="-14.7" spread="11.6"/>
                    <measurement group_id="O5" value="-13.4" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone-Specific Alkaline Phosphatase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="20.7"/>
                    <measurement group_id="O2" value="-5.1" spread="11.2"/>
                    <measurement group_id="O3" value="3.0" spread="18.9"/>
                    <measurement group_id="O4" value="-13.0" spread="19.0"/>
                    <measurement group_id="O5" value="-8.1" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49</title>
        <time_frame>Baseline, Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood Osteocalcin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="11.9"/>
                    <measurement group_id="O2" value="-10.7" spread="8.5"/>
                    <measurement group_id="O3" value="-5.1" spread="17.1"/>
                    <measurement group_id="O4" value="-11.0" spread="9.3"/>
                    <measurement group_id="O5" value="-4.8" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bone-Specific Alkaline Phosphatase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="20.6"/>
                    <measurement group_id="O2" value="-3.9" spread="14.4"/>
                    <measurement group_id="O3" value="-0.9" spread="13.2"/>
                    <measurement group_id="O4" value="-9.6" spread="16.6"/>
                    <measurement group_id="O5" value="0.7" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>units per liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.97" spread="0.53"/>
                    <measurement group_id="O2" value="2.72" spread="0.48"/>
                    <measurement group_id="O3" value="3.10" spread="0.73"/>
                    <measurement group_id="O4" value="2.78" spread="0.62"/>
                    <measurement group_id="O5" value="3.08" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25</title>
        <time_frame>Baseline, Day 25</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="9.4"/>
                    <measurement group_id="O2" value="-1.7" spread="12.6"/>
                    <measurement group_id="O3" value="1.9" spread="11.0"/>
                    <measurement group_id="O4" value="-0.4" spread="10.6"/>
                    <measurement group_id="O5" value="-1.4" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39</title>
        <time_frame>Baseline, Day 39</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="10.7"/>
                    <measurement group_id="O2" value="-0.4" spread="11.6"/>
                    <measurement group_id="O3" value="0.2" spread="10.0"/>
                    <measurement group_id="O4" value="-2.9" spread="9.9"/>
                    <measurement group_id="O5" value="3.7" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49</title>
        <time_frame>Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;N&quot; (number of participants analyzed) signifies those participants who were evaluable for this measure.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="10.2"/>
                    <measurement group_id="O2" value="3.1" spread="18.0"/>
                    <measurement group_id="O3" value="-0.8" spread="12.0"/>
                    <measurement group_id="O4" value="-0.1" spread="9.3"/>
                    <measurement group_id="O5" value="-1.1" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline</title>
        <time_frame>Baseline</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively.</population>
          <units>milligram per 24 hours (mg/24hr)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urine Calcium (n=20, 20, 20, 20, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296.4" spread="143.4"/>
                    <measurement group_id="O2" value="202.1" spread="104.5"/>
                    <measurement group_id="O3" value="224.3" spread="122.2"/>
                    <measurement group_id="O4" value="205.3" spread="100.1"/>
                    <measurement group_id="O5" value="207.4" spread="112.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Phosphate (n=21, 20, 20, 21, 21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="922.1" spread="430.3"/>
                    <measurement group_id="O2" value="673.2" spread="228.3"/>
                    <measurement group_id="O3" value="859.1" spread="318.7"/>
                    <measurement group_id="O4" value="795.4" spread="294.4"/>
                    <measurement group_id="O5" value="755.3" spread="292.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24</title>
        <time_frame>Day 24</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O5">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively</population>
          <units>mg/24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="22"/>
                <count group_id="O5" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urine Calcium (n=17, 17, 16, 15, 19)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.3" spread="106.3"/>
                    <measurement group_id="O2" value="-9.1" spread="69.6"/>
                    <measurement group_id="O3" value="38.0" spread="131.9"/>
                    <measurement group_id="O4" value="8.2" spread="69.0"/>
                    <measurement group_id="O5" value="5.1" spread="89.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Phosphate (n=18, 16, 16, 15, 18)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" spread="276.0"/>
                    <measurement group_id="O2" value="225.8" spread="283.4"/>
                    <measurement group_id="O3" value="241.6" spread="436.0"/>
                    <measurement group_id="O4" value="244.1" spread="363.4"/>
                    <measurement group_id="O5" value="484.4" spread="514.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1</title>
        <description>Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.</description>
        <time_frame>Day 1</time_frame>
        <population>Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1</title>
          <description>Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.</description>
          <population>Safety Analysis Set included all participants who receive at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for this measure at specified time-points for each arm, respectively</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="22"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-PF- 05231023 Antibodies (n=21, 21, 22, 21)</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>Neutralizing Antibodies (n=0, 0, 0, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.</measurement>
                    <measurement group_id="O2" value="NA">Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.</measurement>
                    <measurement group_id="O3" value="NA">Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.</measurement>
                    <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 Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39</title>
        <description>Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.</description>
        <time_frame>Day 39</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for specified antibodies for each arm, respectively and &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39</title>
          <description>Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.</description>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for specified antibodies for each arm, respectively and &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-PF- 05231023 Antibodies (n=19, 18, 14, 19)</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="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutralizing Antibodies (n=0, 0, 1, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.</measurement>
                    <measurement group_id="O2" value="NA">Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.</measurement>
                    <measurement group_id="O3" value="0"/>
                    <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 Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49</title>
        <time_frame>Day 49</time_frame>
        <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for specified antibodies for each arm, respectively and &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49</title>
          <population>Safety analysis set included all participants who received at least 1 dose of study medication. Here &quot;n&quot; signifies those participants who were evaluable for specified antibodies for each arm, respectively and &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-PF- 05231023 Antibodies (n=19, 18, 14, 19)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutralizing Antibodies (n=0, 2, 0, 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.</measurement>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="NA">Data was not analyzed as none of the participant in this arm was evaluable for neutralizing antibody.</measurement>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose</title>
        <description>AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8</time_frame>
        <population>Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose</title>
          <description>AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>nanogram*hour per milliliter (ng*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108100" spread="41048"/>
                    <measurement group_id="O2" value="206200" spread="107110"/>
                    <measurement group_id="O3" value="376600" spread="134870"/>
                    <measurement group_id="O4" value="475600" spread="99316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="376100" spread="111420"/>
                    <measurement group_id="O2" value="693400" spread="214250"/>
                    <measurement group_id="O3" value="1508000" spread="253030"/>
                    <measurement group_id="O4" value="2004000" spread="405880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose</title>
        <description>Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose</title>
          <description>Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.5" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.5" upper_limit="11.5"/>
                    <measurement group_id="O3" value="0.5" lower_limit="0.5" upper_limit="3.4"/>
                    <measurement group_id="O4" value="0.5" lower_limit="0.5" upper_limit="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.5" upper_limit="5.6"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.5" upper_limit="11.5"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0.5" upper_limit="9.5"/>
                    <measurement group_id="O4" value="1.0" lower_limit="0.5" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose</title>
        <description>Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose</title>
          <description>Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7983" spread="2000"/>
                    <measurement group_id="O2" value="15250" spread="3672"/>
                    <measurement group_id="O3" value="32980" spread="7944"/>
                    <measurement group_id="O4" value="48320" spread="8376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8881" spread="1743"/>
                    <measurement group_id="O2" value="16800" spread="4740"/>
                    <measurement group_id="O3" value="31750" spread="5134"/>
                    <measurement group_id="O4" value="44470" spread="8516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose</title>
        <description>AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose</title>
          <description>AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76520" spread="26169"/>
                    <measurement group_id="O2" value="136200" spread="34051"/>
                    <measurement group_id="O3" value="301200" spread="71897"/>
                    <measurement group_id="O4" value="424700" spread="97424"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="467700" spread="136600"/>
                    <measurement group_id="O2" value="855500" spread="269920"/>
                    <measurement group_id="O3" value="1860000" spread="434690"/>
                    <measurement group_id="O4" value="2326000" spread="433010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose</title>
        <description>Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose</title>
          <description>Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="0.50" upper_limit="1.02"/>
                    <measurement group_id="O2" value="0.53" lower_limit="0.45" upper_limit="1.00"/>
                    <measurement group_id="O3" value="0.79" lower_limit="0.48" upper_limit="3.50"/>
                    <measurement group_id="O4" value="1.00" lower_limit="0.50" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.50" upper_limit="4.55"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.48" upper_limit="4.50"/>
                    <measurement group_id="O3" value="1.00" lower_limit="0.50" upper_limit="4.50"/>
                    <measurement group_id="O4" value="1.00" lower_limit="0.50" upper_limit="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose</title>
        <description>Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose</title>
          <description>Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7697" spread="1622"/>
                    <measurement group_id="O2" value="14450" spread="3428"/>
                    <measurement group_id="O3" value="29610" spread="5300"/>
                    <measurement group_id="O4" value="42260" spread="7419"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9981" spread="3406"/>
                    <measurement group_id="O2" value="16900" spread="3279"/>
                    <measurement group_id="O3" value="33140" spread="9119"/>
                    <measurement group_id="O4" value="48090" spread="17688"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023</title>
        <description>Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023</title>
          <description>Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.70" spread="0.23"/>
                    <measurement group_id="O2" value="0.65" spread="0.20"/>
                    <measurement group_id="O3" value="0.79" spread="0.24"/>
                    <measurement group_id="O4" value="0.90" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.24" spread="0.20"/>
                    <measurement group_id="O2" value="1.28" spread="0.31"/>
                    <measurement group_id="O3" value="1.25" spread="0.15"/>
                    <measurement group_id="O4" value="1.16" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023</title>
        <description>Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023</title>
          <description>Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="0.12"/>
                    <measurement group_id="O2" value="0.96" spread="0.20"/>
                    <measurement group_id="O3" value="0.89" spread="0.23"/>
                    <measurement group_id="O4" value="0.89" spread="0.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="0.27"/>
                    <measurement group_id="O2" value="1.04" spread="0.17"/>
                    <measurement group_id="O3" value="1.04" spread="0.33"/>
                    <measurement group_id="O4" value="1.10" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose</title>
        <description>Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose</title>
          <description>Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0001000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.0001000" spread="0.00000"/>
                    <measurement group_id="O3" value="0.0001000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0001866" spread="3.2348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="768.3" spread="405.33"/>
                    <measurement group_id="O2" value="1213" spread="585.54"/>
                    <measurement group_id="O3" value="3293" spread="1287.0"/>
                    <measurement group_id="O4" value="4182" spread="1646.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose</title>
        <description>Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose</title>
          <description>Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="455.8" spread="156.12"/>
                    <measurement group_id="O2" value="810.7" spread="203.85"/>
                    <measurement group_id="O3" value="1793" spread="426.65"/>
                    <measurement group_id="O4" value="2529" spread="581.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2783" spread="812.93"/>
                    <measurement group_id="O2" value="5091" spread="1605.8"/>
                    <measurement group_id="O3" value="11060" spread="2593.9"/>
                    <measurement group_id="O4" value="13840" spread="2574.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Decay Half-Life (t1/2) of PF-05231023</title>
        <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Decay Half-Life (t1/2) of PF-05231023</title>
          <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="1.0"/>
                    <measurement group_id="O2" value="7.4" spread="1.3"/>
                    <measurement group_id="O3" value="7.4" spread="1.2"/>
                    <measurement group_id="O4" value="8.6" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121.6" spread="16.5"/>
                    <measurement group_id="O2" value="119.3" spread="24.5"/>
                    <measurement group_id="O3" value="114.8" spread="12.5"/>
                    <measurement group_id="O4" value="114.6" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Clearance (CL) of PF-05231023</title>
        <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
        <time_frame>0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49</time_frame>
        <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-05231023 25 mg</title>
            <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O2">
            <title>PF-05231023 50 mg</title>
            <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O3">
            <title>PF-05231023 100 mg</title>
            <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
          <group group_id="O4">
            <title>PF-05231023 150 mg</title>
            <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Clearance (CL) of PF-05231023</title>
          <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.</description>
          <population>PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of interest. Here &quot;N&quot; (number of participants analyzed) signifies participants who were evaluable for this measure.</population>
          <units>liter/hour (L/hr)</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PF-05231023 C-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="0.09"/>
                    <measurement group_id="O2" value="0.37" spread="0.08"/>
                    <measurement group_id="O3" value="0.33" spread="0.09"/>
                    <measurement group_id="O4" value="0.35" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PF-05231023 N-Terminus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.02"/>
                    <measurement group_id="O2" value="0.06" spread="0.02"/>
                    <measurement group_id="O3" value="0.05" spread="0.01"/>
                    <measurement group_id="O4" value="0.06" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="E2">
          <title>PF-05231023 25 mg</title>
          <description>PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="E3">
          <title>PF-05231023 50 mg</title>
          <description>PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="E4">
          <title>PF-05231023 100 mg</title>
          <description>PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
        <group group_id="E5">
          <title>PF-05231023 150 mg</title>
          <description>PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v16.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="12" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hunger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Infusion site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blood pressure diastolic increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Electrocardiogram ST segment abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Increased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Libido decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="21"/>
              </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/NCT01673178
org study id: B2901011
nct id: NCT01673178
lead sponsor: 
has dmc: No
This is a trial in obese subjects who have poor lipid control with and without Type 2
      diabetes mellitus to study the safety, tolerability and pharmacokinetics of multiple doses of
      PF-05231023
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 28 days after last dose
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 events were 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.
measure: Number of Participants With Laboratory Abnormalities
time frame: Baseline up to Day 49
description: Criteria for laboratory test abnormality: Hematology (hemoglobin, hematocrit, red blood corpuscles [RBC] count: less than [<]0.8*lower limit of normal [LLN], platelets: <0.5*LLN/greater than [>]1.75*upper limit of normal [ULN], leukocytes: <0.6*LLN or >1.5*ULN, lymphocytes, total neutrophils: <0.8*LLN or >1.2*ULN, basophils, eosinophil: <0.8*LLN, monocytes: >1.2*ULN); Liver Function (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >0.3*ULN, total protein, albumin: <0.8*LLN or >1.2*ULN); total bilirubin, direct bilirubin, indirect bilirubin: >1.5*ULN; Renal Function (blood urea nitrogen, creatinine: >1.3*ULN, uric acid: >1.2*ULN); Electrolytes (sodium: <0.95*LLN or >1.05*ULN, potassium, chloride, calcium, bicarbonate: <0.9*LLN or >1.1*ULN; creatine kinase: >2.0*ULN; glucose fasting: <0.6*LLN or >1.5*ULN, urine white blood corpuscles [WBC] and RBC: greater than or equal to (>=) 20/High Power Field [HPF]).
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities
time frame: Baseline up to Day 49
description: Criteria for clinically significant vital signs abnormalities included supine/sitting pulse rate of <40 beats per minute (bpm) or >120 bpm, supine systolic blood pressure (SBP) of <90 millimeter of mercury (mmHg), >=30 mmHg maximum increase and decrease from baseline in same posture, supine diastolic blood pressure (DBP) of <50 mmHg; >=20 mmHg maximum increase and decrease from baseline in same posture.
measure: Number of Participants With Clinically Significant Electrocardiogram Findings
time frame: Baseline up to Day 49
description: Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25 percent (%) increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=140 msec or >=50% increase from baseline; QT interval >=500 msec, corrected QT interval based on Fridericia's formula (QTcF) 450 to <480 msec, 480 to <500 msec, >=500 msec or >=30 msec but <60 msec increase from baseline or >=60 msec increase from baseline.
measure: Number of Participants With Abnormal Physical Examinations
time frame: Baseline up to Day 49
description: Physical examination included general examination and examination of head, ears, eyes, nose, mouth, throat, neck, abdomen, skin, heart, lungs, lymph nodes, and gastrointestinal and musculoskeletal and neurological system.
measure: Thyroid Stimulating Hormone (TSH) Level at Baseline
time frame: Baseline
description: Results are reported in micro international units per milliliter (mcIU/mL).
measure: Thyroid Stimulating Hormone (TSH) Level at Day 1
time frame: Day 1
measure: Thyroid Stimulating Hormone (TSH) Level at Day 25
time frame: Day 25
measure: Thyroid Stimulating Hormone (TSH) Level at Day 39
time frame: Day 39
measure: Thyroid Stimulating Hormone (TSH) Level at Day 49
time frame: Day 49
measure: Phosphate Level at Baseline
time frame: Baseline
measure: Change From Baseline in Phosphate Level at Day 8
time frame: Baseline, Day 8
measure: Change From Baseline in Phosphate Level at Day 15
time frame: Baseline, Day 15
measure: Change From Baseline in Phosphate Level at Day 25
time frame: Baseline, Day 25
measure: Change From Baseline in Phosphate Level at Day 49
time frame: Baseline, Day 49
measure: Creatine Phosphokinase (CPK) Level at Baseline
time frame: Baseline
measure: Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8
time frame: Baseline, Day 8
measure: Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15
time frame: Baseline, Day 15
measure: Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25
time frame: Baseline, Day 25
measure: Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49
time frame: Baseline, Day 49
measure: Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline
time frame: Baseline
measure: Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25
time frame: Baseline, Day 25
measure: Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39
time frame: Baseline, Day 39
measure: Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49
time frame: Baseline, Day 49
measure: Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline
time frame: Baseline
measure: Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25
time frame: Baseline, Day 25
measure: Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39
time frame: Baseline, Day 39
measure: Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49
time frame: Baseline, Day 49
measure: Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline
time frame: Baseline
measure: Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25
time frame: Baseline, Day 25
measure: Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39
time frame: Baseline, Day 39
measure: Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49
time frame: Day 49
measure: Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline
time frame: Baseline
measure: Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24
time frame: Day 24
measure: Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1
time frame: Day 1
description: Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 1 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
measure: Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39
time frame: Day 39
description: Anti-PF-05231023 antibodies and neutralizing antibodies were analyzed only for participants who received PF-05231023 as per planned analysis. One sample at Day 39 was inadvertently tested for neutralizing antibody even though the corresponding anti-PF-05231023 antibody was negative.
measure: Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49
time frame: Day 49
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8
description: AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
description: Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8
description: Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29
description: AUCtau was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
description: Tmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
description: Cmax was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023
time frame: 0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29
description: Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023
time frame: 0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49
description: Rac was obtained from AUCtau after last dose (Day 22) divided by AUCtau after single dose (Day 1). Rac was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
description: Cmin was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
description: Cav was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Plasma Decay Half-Life (t1/2) of PF-05231023
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Half-Life was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
measure: Apparent Clearance (CL) of PF-05231023
time frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49
description: CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL was calculated for the intact C-terminus and N-terminus PF-05231023 from the concentration-time data using standard non-compartmental method. Only participants who received PF-05231023 were to be analyzed for this outcome measure.
arm group label: Placebo Arm
arm group type: Placebo Comparator
arm group label: 25 mg
arm group type: Experimental
arm group label: 50 mg
arm group type: Experimental
arm group label: 100 mg
arm group type: Experimental
arm group label: 150 mg
arm group type: Experimental
intervention type: Other
intervention name: Placebo
description: 0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
arm group label: Placebo Arm
intervention type: Drug
intervention name: 25 mg PF-05231023
description: 25 mg IV once a week for 4 weeks
arm group label: 25 mg
intervention type: Drug
intervention name: 50 mg PF-05231023
description: 50 mg IV once a week for 4 weeks
arm group label: 50 mg
intervention type: Drug
intervention name: 100 mg PF-05231023
description: 100 mg IV once a week for 4 weeks
arm group label: 100 mg
intervention type: Drug
intervention name: 150 mg PF-05231023
description: 150 mg IV once a week for 4 weeks
arm group label: 150 mg
criteria: 
gender: All
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
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country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2901011&StudyName=Multiple%20Dose%20Study%20Of%20PF-05231023%20In%20Adult%20Subjects%20Who%20Have%20Poor%20Lipid%20Control%20With%20And%20Without%20Type%202%20Diabetes%20Mellitus
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 