<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/NCT03796676</url>
  </required_header>
  <id_info>
    <org_study_id>B7451036</org_study_id>
    <secondary_id>JADE TEEN</secondary_id>
    <secondary_id>2018-003804-37</secondary_id>
    <nct_id>NCT03796676</nct_id>
  </id_info>
  <brief_title>JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis</brief_title>
  <acronym>JADE TEEN</acronym>
  <official_title>A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 CO-ADMINISTERED WITH BACKGROUND MEDICATED TOPICAL THERAPY IN ADOLESCENT PARTICIPANTS 12 TO &lt;18 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to&#xD;
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to &lt;18 years of&#xD;
      age with moderate to severe AD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to&#xD;
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to &lt;18 years of&#xD;
      age with moderate to severe AD. Participants will be screened within 28 days prior to the&#xD;
      first dose of study intervention to confirm study eligibility. Subjects must have&#xD;
      moderate-severe AD involving at least 10% Body Surface Area (BSA); an Investigator Global&#xD;
      Assessment (IGA) score of at least 3; an Eczema Area Severity Index (EASI) of at least 16 and&#xD;
      Peak Pruritus Numerical Rating Score (NRS) of at least 4 on baseline/Day 1. Eligible subjects&#xD;
      will be randomized at the Baseline/Day 1 visit. Approximately 225 participants will be&#xD;
      randomized in a 1:1:1 ratio to receive once daily PF 04965842 at 200 mg, 100 mg, or placebo&#xD;
      for 12 weeks. Randomization will be stratified by baseline disease severity (moderate [IGA =&#xD;
      3] vs. severe [IGA = 4] AD). The investigational products will be administered QD for 12&#xD;
      weeks. Background therapy (medicated and non-medicated topical therapy) must be applied BID&#xD;
      for the duration of the treatment period. The co-primary efficacy endpoints are an IGA score&#xD;
      of clear (0) or almost clear (1) with a reduction from baseline of greater than 2 points at&#xD;
      Week 12 AND an at least 75% improvement of the EASI score (EASI-75) at week 12. Safety and&#xD;
      efficacy assessments will be conducted at the investigator site by a clinical assessor&#xD;
      blinded to treatment assignment. Scheduled clinic or telephone study visits for all subjects&#xD;
      will occur at Screening, Baseline/Day 1, Day 8 (by phone), Day 15, Day 29, Day 43 (by phone),&#xD;
      Day 57, Day 85 (End of treatment/Early termination), Day 113 (End of Study). Participants&#xD;
      discontinuing early from the study will undergo a 4 week follow up period.&#xD;
&#xD;
      This study includes an immunogenicity sub study integrated into the last 4 weeks of the main&#xD;
      study treatment period. At Week 8, up to approximately 90 participants (up to approximately&#xD;
      30 in each treatment arm) who have completed 8 weeks of treatment with study intervention&#xD;
      will receive a tetanus, diphtheria and acellular pertussis combination vaccine (Tdap), and&#xD;
      collection of blood samples for the evaluation of immunogenicity at Weeks 8 and 12.&#xD;
      Participants of this sub study will complete all other protocol specified procedures in the&#xD;
      main study.&#xD;
&#xD;
      At the end of the 12 week study treatment, qualified participants completing the study will&#xD;
      have the option to enter the long term extension (LTE) study B7451015.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2019</start_date>
  <completion_date type="Actual">April 8, 2020</completion_date>
  <primary_completion_date type="Actual">April 8, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12</measure>
    <time_frame>Baseline, Weeks 2, 4 and 12</time_frame>
    <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10). Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep &amp; Usual Activities Questions and Patient Global Impression of Severity &amp; Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12</measure>
    <time_frame>Baseline, Weeks 2, 4 and 8</time_frame>
    <description>The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12</measure>
    <time_frame>Baseline, Weeks 2, 4 and 8</time_frame>
    <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving EASI Response =100% Improvement From Baseline</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in EASI Score</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12</measure>
    <time_frame>Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15</time_frame>
    <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10). Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus</measure>
    <time_frame>Baseline to Week 16</time_frame>
    <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in PP-NRS for Severity of Pruritus</measure>
    <time_frame>Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15</time_frame>
    <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Percentage Body Surface Area (BSA)</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Percentage BSA</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Percentage BSA &lt; 5% at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SCORAD Total Score</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in SCORAD Total Score</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where &quot;0&quot; is no itch (or no sleep loss) and &quot;10&quot; is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where &quot;0&quot; is no itch (or no sleep loss) and &quot;10&quot; is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days When a Corticosteroid Not Used up to Day 88</measure>
    <time_frame>Baseline to Day 88</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Children's Dermatology Life Quality Index (DLQI)</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; and &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; and &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Depression of HADS</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient-Oriented Eczema Measure (POEM)</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as &quot;no days (0)&quot;, &quot;1-2 days (1)&quot;, &quot;3-4 days (2)&quot;, &quot;5-6 days (3)&quot; and &quot;every day (4)&quot;. The score ranges from 0 to 28. The higher values represent more severe AD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatitis Family Impact (DFI) at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; or &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse impact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Global Assessment (PtGA)</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, &quot;severe (4)&quot;, &quot;moderate (3)&quot;, &quot;mild (2)&quot;,&quot;almost clear (1)&quot;, and &quot;clear (0)&quot;. The PtGA was completed as per schedule of activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, &quot;severe (4)&quot;, &quot;moderate (3)&quot;, &quot;mild (2)&quot;,&quot;almost clear (1)&quot;, and &quot;clear (0)&quot;. The PtGA was completed as per schedule of activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score</measure>
    <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
    <description>The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>16 weeks</time_frame>
    <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>16 weeks</time_frame>
    <description>A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued From the Study Due to TEAEs</measure>
    <time_frame>16 weeks</time_frame>
    <description>An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria</measure>
    <time_frame>16 weeks</time_frame>
    <description>A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to &gt;500 ms or &gt;60 ms change from screening ECG); data are presented below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Categorization of Vital Signs Data Meeting Prespecified Criteria</measure>
    <time_frame>16 weeks</time_frame>
    <description>Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination</measure>
    <time_frame>4 weeks post-vaccination with Tdap (Week 12)</time_frame>
    <description>The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to &lt;18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma PF-04965842 Concentration at Week 8</measure>
    <time_frame>2 hours pre-dose at Week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma PF-04965842 Concentration at Week 12</measure>
    <time_frame>2 hours post-dose at Week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">287</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-04965842 100 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-04965842 200 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04965842</intervention_name>
    <description>100 mg QD</description>
    <arm_group_label>PF-04965842 100 mg QD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF04965842</intervention_name>
    <description>200 mg QD</description>
    <arm_group_label>PF-04965842 200 mg QD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 12 and to 17 with a minimum body weight of 40 kg&#xD;
&#xD;
          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate&#xD;
             to severe disease (&gt;= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS&#xD;
             severity 4)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute or chronic medical or laboratory abnormality that may increase the risk&#xD;
             associated with study participation&#xD;
&#xD;
          -  Unwilling to discontinue current AD medications prior to the study or require&#xD;
             treatment with prohibited medications during the study&#xD;
&#xD;
          -  Prior treatment with JAK inhibitors&#xD;
&#xD;
          -  Other active non-AD inflammatory skin diseases or conditions affecting skin&#xD;
&#xD;
          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,&#xD;
             malignancies, current or history of certain infections, lymphoproliferative disorders&#xD;
             and other medical conditions at the discretion of the investigator&#xD;
&#xD;
          -  Pregnant or breastfeeding women, or women of childbearing potential who are unwilling&#xD;
             to use contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 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>Clinical Research Center of Alabama, LLC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35244</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Madera Family Medical Group</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allergy &amp; Asthma Associates of Southern California dba Southern California Research</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moonshine Research Center, Inc.</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homestead Research Institute</name>
      <address>
        <city>Homestead</city>
        <state>Florida</state>
        <zip>33030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Olympian Clinical Research</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials Solutions</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Health Clinical Trials Corp</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Salud Research Clinic, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Miami Medical &amp; Research Group, Inc.</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciocca Dermatology, PA</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INTERMED Medical Research Center, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33175</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Research Associates</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33184</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Pediatric Dermatology Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando - Investigational Drug Services</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Outpatient Service Center-AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Outpatient Procedures and Sedation</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NeuroSkeletal Imaging</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - Pure Skin Dermatology &amp; Aesthetics</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accel Research Sites - Nona Pediatric Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32829</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ForCare Clinical Research</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Allergy Sinus Asthma, SC</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University HealthSystem Dermatology Clinical Trials Unit</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dawes Fretzin Clinical Research Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The South Bend Clinic Center for Research</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forefront Dermatology S.C.</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Asthma and Allergy</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermAssociates, LLC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Clinical Research, Inc.</name>
      <address>
        <city>White Marsh</city>
        <state>Maryland</state>
        <zip>21162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clarkston Skin Research</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne State University / Integrative Biosciences Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Outpatient Health</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Children's Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consortium</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch Center of New York, Inc.</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Science Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Institute for Clinical Research, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies, LTD.LLP</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia Research Institute</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin Investigational Drug Service</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wisconsin Translational Research Unit</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Australian Clinical Research Network</name>
      <address>
        <city>Maroubra</city>
        <state>New South Wales</state>
        <zip>2035</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Skin Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Skin Centre</name>
      <address>
        <city>Benowa</city>
        <state>Queensland</state>
        <zip>4217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinclair Dermatology</name>
      <address>
        <city>East Melbourne</city>
        <state>Victoria (vic)</state>
        <zip>3002</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Children's Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Fujian Medical University, Dermatology Department</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Hospital of Jiangxi Province</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Institute of Dermatology and Venereology &amp; Shandong Provincial Hospital for Skin</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangzhou Third Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine/Dermatology Dept</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine/Dermatology</name>
      <address>
        <city>Shanghai</city>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Dermatology Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200443</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lekarna Na Vaclavskem namesti</name>
      <address>
        <city>Kutna Hora</city>
        <zip>284 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kozni ambulance Kutna Hora, s.r.o</name>
      <address>
        <city>Kutna Hora</city>
        <zip>28401</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermamedica S.R.O.</name>
      <address>
        <city>Nachod</city>
        <zip>547 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oblastni nemocnice Nachod</name>
      <address>
        <city>Nachod</city>
        <zip>547 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lekarna u Stribrneho orla</name>
      <address>
        <city>Nachod</city>
        <zip>54701</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lekarna Cisarska</name>
      <address>
        <city>Praha 2</city>
        <zip>120 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Czech S.R.O.</name>
      <address>
        <city>Praha 2</city>
        <zip>120 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mestska poliklinika Praha</name>
      <address>
        <city>Praha</city>
        <zip>110 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatovenerologicka ambulance</name>
      <address>
        <city>Svitavy</city>
        <zip>56802</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lekarna na Hranicni</name>
      <address>
        <city>Svitavy</city>
        <zip>56802</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Svitavy</name>
      <address>
        <city>Svitavy</city>
        <zip>56825</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <state>NRW</state>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fachklinik Bad Bentheim Thermalsole- und Schwefelbad Bentheim GmbH</name>
      <address>
        <city>Bad Bentheim</city>
        <zip>48455</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MENSINGDERMA research GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>22391</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniklinik Muenster</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinexpert Kft.</name>
      <address>
        <city>Budapest</city>
        <zip>1033</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bugát Pál Kórház, Bőrgyógyászati Szakrendelés</name>
      <address>
        <city>Gyöngyös</city>
        <zip>3200</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Pharma Kft.</name>
      <address>
        <city>Győr</city>
        <zip>9026</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Pharma Kft.</name>
      <address>
        <city>Kaposvár</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Borsod-Abaúj-Zemplén Megyei Központi Kórház és Gyermek Gasztroenterológia II. emelet</name>
      <address>
        <city>Miskolc</city>
        <zip>3526</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trial Pharma Kft.</name>
      <address>
        <city>Püspökladány</city>
        <zip>4150</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas IRCSS - UOC di Dermatologia</name>
      <address>
        <city>Milano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takagi Dermatological Clinic</name>
      <address>
        <city>Obihiro</city>
        <state>Hokkaido</state>
        <zip>080-0013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Shimizu Clinic</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>657-0846</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noguchi Dermatology Clinic</name>
      <address>
        <city>Kamimashiki-gun</city>
        <state>Kumamoto</state>
        <zip>861-3101</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yoshioka Dermatology Clinic</name>
      <address>
        <city>Neyagawa</city>
        <state>Osaka</state>
        <zip>572-0838</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kume Clinic</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <zip>593-8324</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuwa Clinic</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoshikuma Dermatology・Allergy Clinic</name>
      <address>
        <city>Fukuoka</city>
        <zip>814-0171</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsuda Tomoko Dermatological Clinic</name>
      <address>
        <city>Fukuoka</city>
        <zip>819-0167</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aesthetic dermatology clinic of Prof. J. Kisis</name>
      <address>
        <city>Riga</city>
        <zip>LV-1003</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Outpatient Clinic Of Ventspils</name>
      <address>
        <city>Ventspils</city>
        <zip>LV-3601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil de México Federico Gómez</name>
      <address>
        <city>Del. Cuauhtemoc</city>
        <state>Ciudad DE Mexico</state>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Jesus, I.A.P.</name>
      <address>
        <city>Del. Cuauhtémoc</city>
        <state>Ciudad DE Mexico</state>
        <zip>06090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trials in Medicine S.C.</name>
      <address>
        <city>Cuauhtemoc</city>
        <state>Ciudad DE México</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Institute Saltillo S.A. de C.V.</name>
      <address>
        <city>Saltillo</city>
        <state>Coahuila</state>
        <zip>25020</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Atención Médica e Investigación en Salud</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan</name>
      <address>
        <city>Merida</city>
        <state>Yucatan</state>
        <zip>97130</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicios Hospitalarios de Mexico S.A. de C.V. (Hospital Ángeles Chihuahua)</name>
      <address>
        <city>Chihuahua</city>
        <zip>31238</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sociedad de Metabolismo y Corazón S.C.</name>
      <address>
        <city>Veracruz</city>
        <zip>91900</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KLIMED Marek Klimkiewicz</name>
      <address>
        <city>Bialystok</city>
        <zip>15-704</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Dermatoestetica Prywatny Gabinet Dermatologiczny i Alergologiczny</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-650</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne SENSEMED</name>
      <address>
        <city>Chorzow</city>
        <zip>41-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia Czestochowa</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna &quot;A-DERM-SERWIS&quot;</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-217</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neutrum Lekarze M. Hlebowicz i Partnerzy Spolka Partnerska</name>
      <address>
        <city>Gdansk</city>
        <zip>80-462</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MULTIKLINIKA Salute Sp. z o.o.</name>
      <address>
        <city>Katowice</city>
        <zip>40-123</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Angelius Provita</name>
      <address>
        <city>Katowice</city>
        <zip>40-611</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum medyczne PLEJADY</name>
      <address>
        <city>Krakow</city>
        <zip>30-363</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowskie Centrum Medyczne</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak</name>
      <address>
        <city>Lodz</city>
        <zip>90-436</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermedic Jacek Zdybski</name>
      <address>
        <city>Ostrowiec Swietokrzyski</city>
        <zip>27-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmed</name>
      <address>
        <city>Piotrkow Trybunalski</city>
        <zip>97-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Poznaniu</name>
      <address>
        <city>Poznan</city>
        <zip>60-702</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial w Warszawie</name>
      <address>
        <city>Warszawa</city>
        <zip>01-192</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Polska Sp. z o.o. Oddzial we Wroclawiu</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-381</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Gran Canaria Dr. Negrin</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>LAS Palmas</state>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De La Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultas Externas Dermatologia Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servicio de Radiologia Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chung Shan Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>402</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnsley Hospital NHS Foundation Trust</name>
      <address>
        <city>Barnsley</city>
        <state>South Yorkshire</state>
        <zip>S75 2EP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Latvia</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=B7451036</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>March 18, 2021</results_first_submitted>
  <results_first_submitted_qc>May 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 4, 2021</results_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic Dermatitis, JAK1 inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abrocitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03796676/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT03796676/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 287 adolescent participants were randomized to the study, and 285 adolescent participants received study treatment, including 96 participants in the placebo group, 95 participants in the abrocitinib 100 mg QD group, and 94 participants in the abrocitinib 200 mg QD group.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received two PF-04965842-matching placebo tablets QD</description>
        </group>
        <group group_id="P2">
          <title>PF-04965842 100mg QD</title>
          <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
        </group>
        <group group_id="P3">
          <title>PF-04965842 200mg QD</title>
          <description>Participants received two PF-04965842 100 mg tablets QD</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="96"/>
                <participants group_id="P2" count="95"/>
                <participants group_id="P3" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="92"/>
                <participants group_id="P3" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant did not complete Week 16 due to COVID-19 impact</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received two PF-04965842-matching placebo tablets QD</description>
        </group>
        <group group_id="B2">
          <title>PF-04965842 100mg QD</title>
          <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
        </group>
        <group group_id="B3">
          <title>PF-04965842 200mg QD</title>
          <description>Participants received two PF-04965842 100 mg tablets QD</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="96"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="94"/>
            <count group_id="B4" value="285"/>
          </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="14.8" spread="1.7"/>
                    <measurement group_id="B2" value="15.1" spread="1.8"/>
                    <measurement group_id="B3" value="14.7" spread="1.8"/>
                    <measurement group_id="B4" value="14.9" spread="1.7"/>
                  </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="52"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="69"/>
                    <measurement group_id="B4" value="197"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="160"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiracial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12</title>
        <description>The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12</title>
          <description>The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" lower_limit="15.8" upper_limit="33.2"/>
                    <measurement group_id="O2" value="41.6" lower_limit="31.3" upper_limit="51.8"/>
                    <measurement group_id="O3" value="46.2" lower_limit="36.1" upper_limit="56.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0147</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>16.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.5</ci_lower_limit>
            <ci_upper_limit>29.9</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0030</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>20.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.3</ci_lower_limit>
            <ci_upper_limit>33.9</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12</title>
        <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12</title>
          <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" lower_limit="31.5" upper_limit="51.4"/>
                    <measurement group_id="O2" value="68.5" lower_limit="58.9" upper_limit="78.2"/>
                    <measurement group_id="O3" value="72.0" lower_limit="62.9" upper_limit="81.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>26.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.1</ci_lower_limit>
            <ci_upper_limit>39.8</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>29.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.3</ci_lower_limit>
            <ci_upper_limit>42.5</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12</title>
        <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10). Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12</title>
          <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10). Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" lower_limit="6.0" upper_limit="19.3"/>
                    <measurement group_id="O2" value="27.2" lower_limit="18.1" upper_limit="36.3"/>
                    <measurement group_id="O3" value="38.6" lower_limit="28.5" upper_limit="48.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" lower_limit="12.4" upper_limit="28.9"/>
                    <measurement group_id="O2" value="31.5" lower_limit="21.8" upper_limit="41.1"/>
                    <measurement group_id="O3" value="50.0" lower_limit="39.3" upper_limit="60.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="76"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.8" lower_limit="20.0" upper_limit="39.5"/>
                    <measurement group_id="O2" value="52.6" lower_limit="41.4" upper_limit="63.9"/>
                    <measurement group_id="O3" value="55.4" lower_limit="44.1" upper_limit="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0119</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>14.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>3.5</ci_lower_limit>
            <ci_upper_limit>25.9</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 100 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>26.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.9</ci_lower_limit>
            <ci_upper_limit>38.3</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 2 was calculated by PF-04965842 200 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0971</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>10.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.8</ci_lower_limit>
            <ci_upper_limit>23.6</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 100 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>29.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.0</ci_lower_limit>
            <ci_upper_limit>42.9</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 4 was calculated by PF-04965842 200 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0035</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>22.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.0</ci_lower_limit>
            <ci_upper_limit>37.7</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 100 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0013</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Estimate of difference</param_type>
            <param_value>25.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.6</ci_lower_limit>
            <ci_upper_limit>40.6</ci_upper_limit>
            <estimate_desc>Estimate of the difference in percentages of response at Week 12 was calculated by PF-04965842 200 mg minus placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12</title>
        <description>The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep &amp; Usual Activities Questions and Patient Global Impression of Severity &amp; Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12</title>
          <description>The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep &amp; Usual Activities Questions and Patient Global Impression of Severity &amp; Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" lower_limit="-2.4" upper_limit="-1.6"/>
                    <measurement group_id="O2" value="-2.5" lower_limit="-2.9" upper_limit="-2.1"/>
                    <measurement group_id="O3" value="-2.7" lower_limit="-3.1" upper_limit="-2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0664</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>0.0</ci_upper_limit>
            <estimate_desc>The least squares mean difference at Week 12 was calculated by PF-04965842 100 mg minus placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0142</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.3</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
            <estimate_desc>The least squares mean difference at Week 12 was calculated by PF-04965842 200 mg minus placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12</title>
        <description>The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4 and 8</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12</title>
          <description>The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.0" upper_limit="3.2"/>
                    <measurement group_id="O2" value="6.5" lower_limit="1.5" upper_limit="11.6"/>
                    <measurement group_id="O3" value="12.8" lower_limit="6.0" upper_limit="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="0.0" upper_limit="6.6"/>
                    <measurement group_id="O2" value="19.6" lower_limit="11.5" upper_limit="27.7"/>
                    <measurement group_id="O3" value="38.3" lower_limit="28.5" upper_limit="48.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" lower_limit="8.6" upper_limit="23.4"/>
                    <measurement group_id="O2" value="30.8" lower_limit="21.3" upper_limit="40.3"/>
                    <measurement group_id="O3" value="48.9" lower_limit="38.7" upper_limit="59.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12</title>
        <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4 and 8</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12</title>
          <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="0.2" upper_limit="8.6"/>
                    <measurement group_id="O2" value="19.6" lower_limit="11.5" upper_limit="27.7"/>
                    <measurement group_id="O3" value="25.5" lower_limit="16.7" upper_limit="34.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" lower_limit="7.5" upper_limit="21.6"/>
                    <measurement group_id="O2" value="41.3" lower_limit="31.2" upper_limit="51.4"/>
                    <measurement group_id="O3" value="63.8" lower_limit="54.1" upper_limit="73.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="23.8" upper_limit="42.9"/>
                    <measurement group_id="O2" value="60.4" lower_limit="50.4" upper_limit="70.5"/>
                    <measurement group_id="O3" value="68.5" lower_limit="59.0" upper_limit="78.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline</title>
        <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline</title>
          <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2" lower_limit="15.4" upper_limit="33.0"/>
                    <measurement group_id="O2" value="55.4" lower_limit="45.3" upper_limit="65.6"/>
                    <measurement group_id="O3" value="64.9" lower_limit="55.2" upper_limit="74.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0" lower_limit="41.0" upper_limit="61.0"/>
                    <measurement group_id="O2" value="75.0" lower_limit="66.2" upper_limit="83.8"/>
                    <measurement group_id="O3" value="81.9" lower_limit="74.1" upper_limit="89.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" lower_limit="55.9" upper_limit="75.2"/>
                    <measurement group_id="O2" value="85.7" lower_limit="78.5" upper_limit="92.9"/>
                    <measurement group_id="O3" value="82.6" lower_limit="74.9" upper_limit="90.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.1" lower_limit="59.8" upper_limit="78.5"/>
                    <measurement group_id="O2" value="87.6" lower_limit="80.8" upper_limit="94.5"/>
                    <measurement group_id="O3" value="87.1" lower_limit="80.3" upper_limit="93.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline</title>
        <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline</title>
          <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="8.7" lower_limit="2.9" upper_limit="14.5"/>
                    <measurement group_id="O3" value="10.6" lower_limit="4.4" upper_limit="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="0.0" upper_limit="4.9"/>
                    <measurement group_id="O2" value="17.4" lower_limit="9.6" upper_limit="25.1"/>
                    <measurement group_id="O3" value="30.9" lower_limit="21.5" upper_limit="40.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" lower_limit="6.9" upper_limit="21.0"/>
                    <measurement group_id="O2" value="29.7" lower_limit="20.3" upper_limit="39.1"/>
                    <measurement group_id="O3" value="40.2" lower_limit="30.2" upper_limit="50.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" lower_limit="10.3" upper_limit="25.9"/>
                    <measurement group_id="O2" value="41.6" lower_limit="31.3" upper_limit="51.8"/>
                    <measurement group_id="O3" value="49.5" lower_limit="39.3" upper_limit="59.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving EASI Response =100% Improvement From Baseline</title>
        <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving EASI Response =100% Improvement From Baseline</title>
          <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.0" upper_limit="3.2"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="3.8"/>
                    <measurement group_id="O2" value="2.2" lower_limit="0.0" upper_limit="5.2"/>
                    <measurement group_id="O3" value="5.3" lower_limit="0.8" upper_limit="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="3.9"/>
                    <measurement group_id="O2" value="3.3" lower_limit="0.0" upper_limit="7.0"/>
                    <measurement group_id="O3" value="9.8" lower_limit="3.7" upper_limit="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="0.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.2" lower_limit="0.0" upper_limit="5.3"/>
                    <measurement group_id="O3" value="8.6" lower_limit="2.9" upper_limit="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in EASI Score</title>
        <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in EASI Score</title>
          <description>The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.6" lower_limit="-34.0" upper_limit="-21.2"/>
                    <measurement group_id="O2" value="-51.5" lower_limit="-57.9" upper_limit="-45.1"/>
                    <measurement group_id="O3" value="-54.5" lower_limit="-61.0" upper_limit="-48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.7" lower_limit="-48.3" upper_limit="-35.1"/>
                    <measurement group_id="O2" value="-66.1" lower_limit="-72.7" upper_limit="-59.4"/>
                    <measurement group_id="O3" value="-74.3" lower_limit="-81.0" upper_limit="-67.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-57.6" lower_limit="-63.4" upper_limit="-51.8"/>
                    <measurement group_id="O2" value="-72.6" lower_limit="-78.4" upper_limit="-66.8"/>
                    <measurement group_id="O3" value="-77.8" lower_limit="-83.7" upper_limit="-71.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-63.7" lower_limit="-69.5" upper_limit="-57.9"/>
                    <measurement group_id="O2" value="-77.3" lower_limit="-83.1" upper_limit="-71.5"/>
                    <measurement group_id="O3" value="-80.6" lower_limit="-86.5" upper_limit="-74.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12</title>
        <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10). Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12</title>
          <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10). Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.0" upper_limit="3.6"/>
                    <measurement group_id="O2" value="2.8" lower_limit="0.0" upper_limit="6.7"/>
                    <measurement group_id="O3" value="3.9" lower_limit="0.0" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="4.6"/>
                    <measurement group_id="O2" value="5.1" lower_limit="0.2" upper_limit="9.9"/>
                    <measurement group_id="O3" value="7.7" lower_limit="1.8" upper_limit="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="0.2" upper_limit="9.7"/>
                    <measurement group_id="O2" value="11.5" lower_limit="4.4" upper_limit="18.6"/>
                    <measurement group_id="O3" value="14.3" lower_limit="6.5" upper_limit="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="1.1" upper_limit="12.8"/>
                    <measurement group_id="O2" value="12.2" lower_limit="5.1" upper_limit="19.3"/>
                    <measurement group_id="O3" value="18.5" lower_limit="10.1" upper_limit="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="2.6" upper_limit="14.9"/>
                    <measurement group_id="O2" value="16.0" lower_limit="8.1" upper_limit="24.0"/>
                    <measurement group_id="O3" value="21.3" lower_limit="12.3" upper_limit="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="3.5" upper_limit="16.8"/>
                    <measurement group_id="O2" value="16.0" lower_limit="8.1" upper_limit="24.0"/>
                    <measurement group_id="O3" value="21.3" lower_limit="12.3" upper_limit="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="0.0" upper_limit="8.4"/>
                    <measurement group_id="O2" value="17.3" lower_limit="8.8" upper_limit="25.9"/>
                    <measurement group_id="O3" value="25.0" lower_limit="15.3" upper_limit="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="0.9" upper_limit="11.1"/>
                    <measurement group_id="O2" value="16.0" lower_limit="7.7" upper_limit="24.3"/>
                    <measurement group_id="O3" value="25.0" lower_limit="15.5" upper_limit="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="2.4" upper_limit="14.2"/>
                    <measurement group_id="O2" value="15.6" lower_limit="7.5" upper_limit="23.7"/>
                    <measurement group_id="O3" value="28.8" lower_limit="18.8" upper_limit="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" lower_limit="1.8" upper_limit="13.4"/>
                    <measurement group_id="O2" value="20.8" lower_limit="11.7" upper_limit="29.8"/>
                    <measurement group_id="O3" value="27.0" lower_limit="16.9" upper_limit="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8" lower_limit="3.7" upper_limit="17.9"/>
                    <measurement group_id="O2" value="22.2" lower_limit="12.6" upper_limit="31.8"/>
                    <measurement group_id="O3" value="23.6" lower_limit="13.8" upper_limit="33.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="80"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="3.4" upper_limit="16.6"/>
                    <measurement group_id="O2" value="26.3" lower_limit="16.6" upper_limit="35.9"/>
                    <measurement group_id="O3" value="31.2" lower_limit="20.8" upper_limit="41.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" lower_limit="3.2" upper_limit="15.8"/>
                    <measurement group_id="O2" value="24.7" lower_limit="15.3" upper_limit="34.1"/>
                    <measurement group_id="O3" value="32.4" lower_limit="21.8" upper_limit="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="6.8" upper_limit="21.8"/>
                    <measurement group_id="O2" value="27.7" lower_limit="18.1" upper_limit="37.3"/>
                    <measurement group_id="O3" value="37.8" lower_limit="27.3" upper_limit="48.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus</title>
        <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10).</description>
        <time_frame>Baseline to Week 16</time_frame>
        <population>The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants in the FAS with a baseline numeric rating score for severity of pruritus &gt;=4 were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus</title>
          <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10).</description>
          <population>The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants in the FAS with a baseline numeric rating score for severity of pruritus &gt;=4 were included in the analysis.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" lower_limit="62.0" upper_limit="NA">The upper limit was not evaluable as too few events were observed.</measurement>
                    <measurement group_id="O2" value="70.0" lower_limit="30.0" upper_limit="85.0"/>
                    <measurement group_id="O3" value="29.0" lower_limit="15.0" upper_limit="61.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in PP-NRS for Severity of Pruritus</title>
        <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10).</description>
        <time_frame>Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in PP-NRS for Severity of Pruritus</title>
          <description>PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms &quot;no itch&quot; (0) and &quot;worst itch imaginable&quot; (10).</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="83"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="71"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-5.5" upper_limit="3.6"/>
                    <measurement group_id="O2" value="-9.5" lower_limit="-14.2" upper_limit="-4.8"/>
                    <measurement group_id="O3" value="-5.4" lower_limit="-10.0" upper_limit="-0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="79"/>
                    <count group_id="O3" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-6.0" upper_limit="3.8"/>
                    <measurement group_id="O2" value="-11.3" lower_limit="-16.2" upper_limit="-6.4"/>
                    <measurement group_id="O3" value="-10.2" lower_limit="-15.2" upper_limit="-5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" lower_limit="-10.6" upper_limit="0.5"/>
                    <measurement group_id="O2" value="-14.6" lower_limit="-20.2" upper_limit="-9.1"/>
                    <measurement group_id="O3" value="-14.7" lower_limit="-20.3" upper_limit="-9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="82"/>
                    <count group_id="O3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.5" lower_limit="-15.8" upper_limit="-3.2"/>
                    <measurement group_id="O2" value="-16.1" lower_limit="-22.3" upper_limit="-9.9"/>
                    <measurement group_id="O3" value="-17.6" lower_limit="-23.9" upper_limit="-11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.7" lower_limit="-15.2" upper_limit="-2.2"/>
                    <measurement group_id="O2" value="-18.5" lower_limit="-25.0" upper_limit="-12.1"/>
                    <measurement group_id="O3" value="-18.7" lower_limit="-25.3" upper_limit="-12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.3" lower_limit="-19.4" upper_limit="-5.2"/>
                    <measurement group_id="O2" value="-20.0" lower_limit="-27.1" upper_limit="-12.9"/>
                    <measurement group_id="O3" value="-18.8" lower_limit="-26.0" upper_limit="-11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.6" lower_limit="-17.9" upper_limit="-3.3"/>
                    <measurement group_id="O2" value="-21.6" lower_limit="-28.9" upper_limit="-14.2"/>
                    <measurement group_id="O3" value="-22.7" lower_limit="-30.2" upper_limit="-15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="75"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" lower_limit="-17.6" upper_limit="-2.3"/>
                    <measurement group_id="O2" value="-20.9" lower_limit="-28.7" upper_limit="-13.2"/>
                    <measurement group_id="O3" value="-21.7" lower_limit="-29.5" upper_limit="-13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.8" lower_limit="-17.8" upper_limit="-3.8"/>
                    <measurement group_id="O2" value="-26.1" lower_limit="-33.1" upper_limit="-19.0"/>
                    <measurement group_id="O3" value="-28.0" lower_limit="-35.1" upper_limit="-20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="77"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.7" lower_limit="-17.7" upper_limit="-3.7"/>
                    <measurement group_id="O2" value="-26.5" lower_limit="-33.5" upper_limit="-19.4"/>
                    <measurement group_id="O3" value="-26.3" lower_limit="-33.5" upper_limit="-19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="72"/>
                    <count group_id="O3" value="72"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.0" lower_limit="-18.0" upper_limit="-4.0"/>
                    <measurement group_id="O2" value="-27.0" lower_limit="-34.0" upper_limit="-20.0"/>
                    <measurement group_id="O3" value="-28.9" lower_limit="-36.1" upper_limit="-21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="80"/>
                    <count group_id="O3" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.1" lower_limit="-20.4" upper_limit="-7.8"/>
                    <measurement group_id="O2" value="-25.2" lower_limit="-31.5" upper_limit="-18.8"/>
                    <measurement group_id="O3" value="-32.5" lower_limit="-39.0" upper_limit="-26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.0" lower_limit="-18.1" upper_limit="-5.8"/>
                    <measurement group_id="O2" value="-29.4" lower_limit="-35.5" upper_limit="-23.2"/>
                    <measurement group_id="O3" value="-35.3" lower_limit="-41.6" upper_limit="-29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                    <count group_id="O3" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.8" lower_limit="-22.7" upper_limit="-8.8"/>
                    <measurement group_id="O2" value="-30.7" lower_limit="-37.7" upper_limit="-23.7"/>
                    <measurement group_id="O3" value="-33.4" lower_limit="-40.5" upper_limit="-26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Percentage Body Surface Area (BSA)</title>
        <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Percentage Body Surface Area (BSA)</title>
          <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.9" lower_limit="-14.0" upper_limit="-7.8"/>
                    <measurement group_id="O2" value="-21.0" lower_limit="-24.1" upper_limit="-17.9"/>
                    <measurement group_id="O3" value="-20.7" lower_limit="-23.8" upper_limit="-17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.1" lower_limit="-18.4" upper_limit="-11.7"/>
                    <measurement group_id="O2" value="-27.7" lower_limit="-31.0" upper_limit="-24.3"/>
                    <measurement group_id="O3" value="-32.6" lower_limit="-36.0" upper_limit="-29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.8" lower_limit="-25.3" upper_limit="-18.3"/>
                    <measurement group_id="O2" value="-32.6" lower_limit="-36.1" upper_limit="-29.1"/>
                    <measurement group_id="O3" value="-34.1" lower_limit="-37.7" upper_limit="-30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.2" lower_limit="-27.8" upper_limit="-20.7"/>
                    <measurement group_id="O2" value="-34.4" lower_limit="-38.0" upper_limit="-30.8"/>
                    <measurement group_id="O3" value="-35.2" lower_limit="-38.8" upper_limit="-31.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Percentage BSA</title>
        <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Percentage BSA</title>
          <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.6" lower_limit="-26.7" upper_limit="-14.5"/>
                    <measurement group_id="O2" value="-40.4" lower_limit="-46.5" upper_limit="-34.3"/>
                    <measurement group_id="O3" value="-42.2" lower_limit="-48.3" upper_limit="-36.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.0" lower_limit="-36.3" upper_limit="-21.8"/>
                    <measurement group_id="O2" value="-55.4" lower_limit="-62.7" upper_limit="-48.1"/>
                    <measurement group_id="O3" value="-66.0" lower_limit="-73.4" upper_limit="-58.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.0" lower_limit="-52.6" upper_limit="-39.3"/>
                    <measurement group_id="O2" value="-65.7" lower_limit="-72.4" upper_limit="-59.1"/>
                    <measurement group_id="O3" value="-69.5" lower_limit="-76.3" upper_limit="-62.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.4" lower_limit="-60.1" upper_limit="-46.7"/>
                    <measurement group_id="O2" value="-71.4" lower_limit="-78.2" upper_limit="-64.7"/>
                    <measurement group_id="O3" value="-72.6" lower_limit="-79.3" upper_limit="-65.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Percentage BSA &lt; 5% at Week 12</title>
        <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Percentage BSA &lt; 5% at Week 12</title>
          <description>BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" lower_limit="15.8" upper_limit="33.2"/>
                    <measurement group_id="O2" value="38.2" lower_limit="28.1" upper_limit="48.3"/>
                    <measurement group_id="O3" value="36.6" lower_limit="26.8" upper_limit="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline</title>
        <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline</title>
          <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" lower_limit="2.9" upper_limit="14.3"/>
                    <measurement group_id="O2" value="22.6" lower_limit="14.1" upper_limit="31.1"/>
                    <measurement group_id="O3" value="29.0" lower_limit="19.8" upper_limit="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="15.4" upper_limit="32.5"/>
                    <measurement group_id="O2" value="44.1" lower_limit="34.0" upper_limit="54.2"/>
                    <measurement group_id="O3" value="64.1" lower_limit="54.3" upper_limit="73.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" lower_limit="24.5" upper_limit="43.6"/>
                    <measurement group_id="O2" value="65.6" lower_limit="55.9" upper_limit="75.2"/>
                    <measurement group_id="O3" value="75.0" lower_limit="66.2" upper_limit="83.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.6" lower_limit="27.8" upper_limit="47.5"/>
                    <measurement group_id="O2" value="75.6" lower_limit="66.7" upper_limit="84.4"/>
                    <measurement group_id="O3" value="73.9" lower_limit="64.9" upper_limit="82.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline</title>
        <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline</title>
          <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="3.9"/>
                    <measurement group_id="O2" value="5.4" lower_limit="0.8" upper_limit="10.0"/>
                    <measurement group_id="O3" value="7.5" lower_limit="2.2" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="3.8"/>
                    <measurement group_id="O2" value="11.8" lower_limit="5.3" upper_limit="18.4"/>
                    <measurement group_id="O3" value="21.7" lower_limit="13.3" upper_limit="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" lower_limit="2.9" upper_limit="14.2"/>
                    <measurement group_id="O2" value="17.2" lower_limit="9.5" upper_limit="24.9"/>
                    <measurement group_id="O3" value="33.7" lower_limit="24.0" upper_limit="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" lower_limit="6.1" upper_limit="19.7"/>
                    <measurement group_id="O2" value="36.7" lower_limit="26.7" upper_limit="46.6"/>
                    <measurement group_id="O3" value="34.8" lower_limit="25.1" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SCORAD Total Score</title>
        <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SCORAD Total Score</title>
          <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.3" lower_limit="-15.4" upper_limit="-9.2"/>
                    <measurement group_id="O2" value="-24.6" lower_limit="-27.7" upper_limit="-21.6"/>
                    <measurement group_id="O3" value="-25.8" lower_limit="-28.9" upper_limit="-22.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.2" lower_limit="-23.3" upper_limit="-17.0"/>
                    <measurement group_id="O2" value="-32.4" lower_limit="-35.5" upper_limit="-29.2"/>
                    <measurement group_id="O3" value="-38.0" lower_limit="-41.2" upper_limit="-34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.6" lower_limit="-30.0" upper_limit="-23.2"/>
                    <measurement group_id="O2" value="-37.3" lower_limit="-40.7" upper_limit="-33.9"/>
                    <measurement group_id="O3" value="-41.5" lower_limit="-45.0" upper_limit="-38.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.2" lower_limit="-33.9" upper_limit="-26.4"/>
                    <measurement group_id="O2" value="-40.9" lower_limit="-44.7" upper_limit="-37.2"/>
                    <measurement group_id="O3" value="-42.9" lower_limit="-46.7" upper_limit="-39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in SCORAD Total Score</title>
        <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in SCORAD Total Score</title>
          <description>SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where &quot;0&quot; is no itch (or no sleeplessness) and &quot;10&quot; is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.7" lower_limit="-23.1" upper_limit="-14.2"/>
                    <measurement group_id="O2" value="-36.1" lower_limit="-40.6" upper_limit="-31.7"/>
                    <measurement group_id="O3" value="-38.7" lower_limit="-43.2" upper_limit="-34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.0" lower_limit="-34.5" upper_limit="-25.5"/>
                    <measurement group_id="O2" value="-47.4" lower_limit="-52.0" upper_limit="-42.9"/>
                    <measurement group_id="O3" value="-56.9" lower_limit="-61.6" upper_limit="-52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.9" lower_limit="-44.9" upper_limit="-34.8"/>
                    <measurement group_id="O2" value="-54.0" lower_limit="-59.0" upper_limit="-48.9"/>
                    <measurement group_id="O3" value="-62.0" lower_limit="-67.2" upper_limit="-56.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.4" lower_limit="-50.1" upper_limit="-38.8"/>
                    <measurement group_id="O2" value="-59.2" lower_limit="-64.9" upper_limit="-53.6"/>
                    <measurement group_id="O3" value="-64.3" lower_limit="-70.1" upper_limit="-58.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss</title>
        <description>SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where &quot;0&quot; is no itch (or no sleep loss) and &quot;10&quot; is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss</title>
          <description>SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where &quot;0&quot; is no itch (or no sleep loss) and &quot;10&quot; is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-1.4" upper_limit="-0.4"/>
                    <measurement group_id="O2" value="-2.1" lower_limit="-2.6" upper_limit="-1.6"/>
                    <measurement group_id="O3" value="-2.6" lower_limit="-3.1" upper_limit="-2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" lower_limit="-2.3" upper_limit="-1.3"/>
                    <measurement group_id="O2" value="-2.9" lower_limit="-3.3" upper_limit="-2.4"/>
                    <measurement group_id="O3" value="-3.4" lower_limit="-3.9" upper_limit="-2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.2" lower_limit="-2.7" upper_limit="-1.7"/>
                    <measurement group_id="O2" value="-3.3" lower_limit="-3.8" upper_limit="-2.9"/>
                    <measurement group_id="O3" value="-3.7" lower_limit="-4.2" upper_limit="-3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" lower_limit="-3.2" upper_limit="-2.2"/>
                    <measurement group_id="O2" value="-3.5" lower_limit="-3.9" upper_limit="-3.0"/>
                    <measurement group_id="O3" value="-3.9" lower_limit="-4.4" upper_limit="-3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss</title>
        <description>SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where &quot;0&quot; is no itch (or no sleep loss) and &quot;10&quot; is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss</title>
          <description>SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where &quot;0&quot; is no itch (or no sleep loss) and &quot;10&quot; is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="-101.2" upper_limit="106.3"/>
                    <measurement group_id="O2" value="65.1" lower_limit="-39.2" upper_limit="169.4"/>
                    <measurement group_id="O3" value="-36.5" lower_limit="-140.7" upper_limit="67.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.0" lower_limit="-35.2" upper_limit="-4.9"/>
                    <measurement group_id="O2" value="-35.2" lower_limit="-50.7" upper_limit="-19.8"/>
                    <measurement group_id="O3" value="-53.4" lower_limit="-69.1" upper_limit="-37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.7" lower_limit="-60.1" upper_limit="10.8"/>
                    <measurement group_id="O2" value="-44.2" lower_limit="-79.9" upper_limit="-8.5"/>
                    <measurement group_id="O3" value="-30.6" lower_limit="-66.7" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.5" lower_limit="-77.7" upper_limit="-1.3"/>
                    <measurement group_id="O2" value="-49.8" lower_limit="-88.3" upper_limit="-11.3"/>
                    <measurement group_id="O3" value="-35.2" lower_limit="-74.1" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days When a Corticosteroid Not Used up to Day 88</title>
        <time_frame>Baseline to Day 88</time_frame>
        <population>The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The analysis population included all participants in the FAS who had used corticosteroid during treatment period.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days When a Corticosteroid Not Used up to Day 88</title>
          <population>The Full Analysis Set (FAS) included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The analysis population included all participants in the FAS who had used corticosteroid during treatment period.</population>
          <units>Days</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
                <count group_id="O2" value="89"/>
                <count group_id="O3" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="2.0" upper_limit="11.6"/>
                    <measurement group_id="O2" value="10.9" lower_limit="6.2" upper_limit="15.5"/>
                    <measurement group_id="O3" value="15.1" lower_limit="10.2" upper_limit="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Children's Dermatology Life Quality Index (DLQI)</title>
        <description>The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; and &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Children's Dermatology Life Quality Index (DLQI)</title>
          <description>The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; and &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" lower_limit="-5.1" upper_limit="-3.3"/>
                    <measurement group_id="O2" value="-6.1" lower_limit="-7.1" upper_limit="-5.2"/>
                    <measurement group_id="O3" value="-6.3" lower_limit="-7.2" upper_limit="-5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.4" lower_limit="-6.3" upper_limit="-4.5"/>
                    <measurement group_id="O2" value="-7.3" lower_limit="-8.2" upper_limit="-6.4"/>
                    <measurement group_id="O3" value="-7.6" lower_limit="-8.6" upper_limit="-6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.1" lower_limit="-7.0" upper_limit="-5.1"/>
                    <measurement group_id="O2" value="-8.1" lower_limit="-9.1" upper_limit="-7.1"/>
                    <measurement group_id="O3" value="-8.2" lower_limit="-9.2" upper_limit="-7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.3" lower_limit="-7.4" upper_limit="-5.3"/>
                    <measurement group_id="O2" value="-8.6" lower_limit="-9.6" upper_limit="-7.5"/>
                    <measurement group_id="O3" value="-8.7" lower_limit="-9.7" upper_limit="-7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI</title>
        <description>The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; and &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI</title>
          <description>The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; and &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="92"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.5" lower_limit="51.5" upper_limit="71.5"/>
                    <measurement group_id="O2" value="73.6" lower_limit="64.6" upper_limit="82.7"/>
                    <measurement group_id="O3" value="71.3" lower_limit="62.1" upper_limit="80.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.7" lower_limit="64.8" upper_limit="82.5"/>
                    <measurement group_id="O2" value="82.4" lower_limit="74.6" upper_limit="90.2"/>
                    <measurement group_id="O3" value="73.4" lower_limit="64.5" upper_limit="82.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0" lower_limit="61.7" upper_limit="80.2"/>
                    <measurement group_id="O2" value="85.9" lower_limit="78.8" upper_limit="93.0"/>
                    <measurement group_id="O3" value="79.6" lower_limit="71.4" upper_limit="87.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="89"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.7" lower_limit="58.2" upper_limit="77.2"/>
                    <measurement group_id="O2" value="80.9" lower_limit="72.7" upper_limit="89.1"/>
                    <measurement group_id="O3" value="78.5" lower_limit="70.1" upper_limit="86.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)</title>
        <description>The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)</title>
          <description>The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" lower_limit="-1.7" upper_limit="-0.7"/>
                    <measurement group_id="O2" value="-1.6" lower_limit="-2.1" upper_limit="-1.1"/>
                    <measurement group_id="O3" value="-1.3" lower_limit="-1.8" upper_limit="-0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.5" lower_limit="-2.1" upper_limit="-1.0"/>
                    <measurement group_id="O2" value="-1.6" lower_limit="-2.2" upper_limit="-1.1"/>
                    <measurement group_id="O3" value="-1.9" lower_limit="-2.5" upper_limit="-1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" lower_limit="-2.3" upper_limit="-1.1"/>
                    <measurement group_id="O2" value="-2.1" lower_limit="-2.7" upper_limit="-1.5"/>
                    <measurement group_id="O3" value="-2.2" lower_limit="-2.8" upper_limit="-1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" lower_limit="-2.7" upper_limit="-1.5"/>
                    <measurement group_id="O2" value="-2.0" lower_limit="-2.6" upper_limit="-1.4"/>
                    <measurement group_id="O3" value="-2.4" lower_limit="-3.0" upper_limit="-1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Depression of HADS</title>
        <description>The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Depression of HADS</title>
          <description>The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-1.3" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-1.2" lower_limit="-1.7" upper_limit="-0.8"/>
                    <measurement group_id="O3" value="-0.8" lower_limit="-1.3" upper_limit="-0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-1.3" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-1.3" lower_limit="-1.8" upper_limit="-0.8"/>
                    <measurement group_id="O3" value="-1.3" lower_limit="-1.8" upper_limit="-0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" lower_limit="-1.6" upper_limit="-0.6"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-1.9" upper_limit="-0.9"/>
                    <measurement group_id="O3" value="-1.2" lower_limit="-1.7" upper_limit="-0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" lower_limit="-1.5" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-1.9" upper_limit="-0.8"/>
                    <measurement group_id="O3" value="-1.2" lower_limit="-1.7" upper_limit="-0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient-Oriented Eczema Measure (POEM)</title>
        <description>The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as &quot;no days (0)&quot;, &quot;1-2 days (1)&quot;, &quot;3-4 days (2)&quot;, &quot;5-6 days (3)&quot; and &quot;every day (4)&quot;. The score ranges from 0 to 28. The higher values represent more severe AD.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient-Oriented Eczema Measure (POEM)</title>
          <description>The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as &quot;no days (0)&quot;, &quot;1-2 days (1)&quot;, &quot;3-4 days (2)&quot;, &quot;5-6 days (3)&quot; and &quot;every day (4)&quot;. The score ranges from 0 to 28. The higher values represent more severe AD.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="95"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" lower_limit="-4.7" upper_limit="-2.1"/>
                    <measurement group_id="O2" value="-6.9" lower_limit="-8.2" upper_limit="-5.6"/>
                    <measurement group_id="O3" value="-8.2" lower_limit="-9.5" upper_limit="-6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.8" lower_limit="-6.0" upper_limit="-3.6"/>
                    <measurement group_id="O2" value="-9.5" lower_limit="-10.7" upper_limit="-8.3"/>
                    <measurement group_id="O3" value="-10.6" lower_limit="-11.9" upper_limit="-9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.4" lower_limit="-6.7" upper_limit="-4.0"/>
                    <measurement group_id="O2" value="-10.0" lower_limit="-11.4" upper_limit="-8.7"/>
                    <measurement group_id="O3" value="-10.6" lower_limit="-12.0" upper_limit="-9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.9" lower_limit="-8.3" upper_limit="-5.6"/>
                    <measurement group_id="O2" value="-11.1" lower_limit="-12.5" upper_limit="-9.7"/>
                    <measurement group_id="O3" value="-10.9" lower_limit="-12.2" upper_limit="-9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatitis Family Impact (DFI) at Week 12</title>
        <description>The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; or &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse impact.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatitis Family Impact (DFI) at Week 12</title>
          <description>The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as &quot;very much (3)&quot;, &quot;a lot (2)&quot;, &quot;a little (1)&quot; or &quot;not at all (0)&quot;. The score can range from 0 to 30. The higher values represent the worse impact.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this time point.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" lower_limit="-6.5" upper_limit="-3.9"/>
                    <measurement group_id="O2" value="-6.7" lower_limit="-7.9" upper_limit="-5.4"/>
                    <measurement group_id="O3" value="-7.3" lower_limit="-8.6" upper_limit="-6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Global Assessment (PtGA)</title>
        <description>The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, &quot;severe (4)&quot;, &quot;moderate (3)&quot;, &quot;mild (2)&quot;,&quot;almost clear (1)&quot;, and &quot;clear (0)&quot;. The PtGA was completed as per schedule of activities.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Global Assessment (PtGA)</title>
          <description>The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, &quot;severe (4)&quot;, &quot;moderate (3)&quot;, &quot;mild (2)&quot;,&quot;almost clear (1)&quot;, and &quot;clear (0)&quot;. The PtGA was completed as per schedule of activities.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" lower_limit="-0.6" upper_limit="-0.3"/>
                    <measurement group_id="O2" value="-0.7" lower_limit="-0.9" upper_limit="-0.6"/>
                    <measurement group_id="O3" value="-1.0" lower_limit="-1.1" upper_limit="-0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.7" lower_limit="-0.8" upper_limit="-0.5"/>
                    <measurement group_id="O2" value="-0.9" lower_limit="-1.1" upper_limit="-0.8"/>
                    <measurement group_id="O3" value="-1.2" lower_limit="-1.4" upper_limit="-1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" lower_limit="-1.0" upper_limit="-0.6"/>
                    <measurement group_id="O2" value="-1.2" lower_limit="-1.3" upper_limit="-1.0"/>
                    <measurement group_id="O3" value="-1.4" lower_limit="-1.6" upper_limit="-1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" lower_limit="-1.1" upper_limit="-0.7"/>
                    <measurement group_id="O2" value="-1.4" lower_limit="-1.6" upper_limit="-1.2"/>
                    <measurement group_id="O3" value="-1.6" lower_limit="-1.8" upper_limit="-1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA</title>
        <description>The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, &quot;severe (4)&quot;, &quot;moderate (3)&quot;, &quot;mild (2)&quot;,&quot;almost clear (1)&quot;, and &quot;clear (0)&quot;. The PtGA was completed as per schedule of activities.</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA</title>
          <description>The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, &quot;severe (4)&quot;, &quot;moderate (3)&quot;, &quot;mild (2)&quot;,&quot;almost clear (1)&quot;, and &quot;clear (0)&quot;. The PtGA was completed as per schedule of activities.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants evaluable for this outcome measure. Number analyzed refers to the number of participants evaluable for each time point.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.0" upper_limit="3.2"/>
                    <measurement group_id="O2" value="5.4" lower_limit="0.8" upper_limit="10.1"/>
                    <measurement group_id="O3" value="5.3" lower_limit="0.8" upper_limit="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="92"/>
                    <count group_id="O3" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="0.2" upper_limit="8.2"/>
                    <measurement group_id="O2" value="14.1" lower_limit="7.0" upper_limit="21.2"/>
                    <measurement group_id="O3" value="20.2" lower_limit="12.1" upper_limit="28.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" lower_limit="1.4" upper_limit="11.3"/>
                    <measurement group_id="O2" value="22.6" lower_limit="14.1" upper_limit="31.1"/>
                    <measurement group_id="O3" value="26.9" lower_limit="17.9" upper_limit="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="4.4" upper_limit="16.9"/>
                    <measurement group_id="O2" value="30.0" lower_limit="20.5" upper_limit="39.5"/>
                    <measurement group_id="O3" value="36.6" lower_limit="26.8" upper_limit="46.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score</title>
        <description>The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).</description>
        <time_frame>Baseline, Weeks 2, 4, 8 and 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score</title>
          <description>The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.140" lower_limit="3.787" upper_limit="10.492"/>
                    <measurement group_id="O2" value="11.241" lower_limit="7.882" upper_limit="14.601"/>
                    <measurement group_id="O3" value="12.141" lower_limit="8.763" upper_limit="15.520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.784" lower_limit="5.625" upper_limit="11.943"/>
                    <measurement group_id="O2" value="13.222" lower_limit="10.020" upper_limit="16.423"/>
                    <measurement group_id="O3" value="14.677" lower_limit="11.438" upper_limit="17.917"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.415" lower_limit="4.888" upper_limit="11.941"/>
                    <measurement group_id="O2" value="14.502" lower_limit="10.977" upper_limit="18.028"/>
                    <measurement group_id="O3" value="14.653" lower_limit="11.076" upper_limit="18.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.944" lower_limit="6.373" upper_limit="13.515"/>
                    <measurement group_id="O2" value="14.226" lower_limit="10.624" upper_limit="17.828"/>
                    <measurement group_id="O3" value="15.756" lower_limit="12.153" upper_limit="19.360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12</title>
        <description>The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12</title>
          <description>The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.1" upper_limit="3.9"/>
                    <measurement group_id="O2" value="4.5" lower_limit="3.0" upper_limit="5.9"/>
                    <measurement group_id="O3" value="4.3" lower_limit="2.9" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.</description>
        <time_frame>16 weeks</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-causality TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <description>A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.</description>
        <time_frame>16 weeks</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <description>A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-causality SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued From the Study Due to TEAEs</title>
        <description>An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.</description>
        <time_frame>16 weeks</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued From the Study Due to TEAEs</title>
          <description>An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All-causality TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)</title>
        <description>Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.</description>
        <time_frame>16 weeks</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants with at least one observation of the given laboratory test.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)</title>
          <description>Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure. Number analyzed refers to the number of participants with at least one observation of the given laboratory test.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin (g/dL) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (%) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes (10^6/mm^3) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes (10^3/mm^3) &lt;0.5*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes (10^3/mm^3) &gt;1.5*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume (10^-15L) &lt;0.9*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Volume (10^-15L) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin (pg/cell) &lt;0.9*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular Hemoglobin (pg/cell) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular HGB Concentration (g/dL) &lt;0.9*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. Mean Corpuscular HGB Concentration (g/dL) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (10^3/mm^3) &lt;0.5*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets (10^3/mm^3) &gt;1.75*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes/Erythrocytes (%) &lt;0.5*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reticulocytes/Erythrocytes (%) &gt;1.5*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (10^3/mm^3) &lt;0.6*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (10^3/mm^3) &gt;1.5*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (10^3/mm^3) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (10^3/mm^3) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes (%) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes/Leukocytes (%) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (10^3/mm^3) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (10^3/mm^3) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes (%) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils/Leukocytes (%) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils (10^3/mm^3) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils/Leukocytes (%) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils (10^3/mm^3) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils/Leukocytes (%) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="62"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes (10^3/mm^3) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes/Leukocytes (%) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Activated Partial Thromboplastin Time (sec) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prothrombin Time (sec) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prothrombin Intl.Normalized Ratio &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin (mg/dL) &gt;1.5*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin (mg/dL) &gt;1.5*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin (mg/dL) &gt;1.5*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="93"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (U/L) &gt;3.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Aminotransferase (U/L) &gt;3.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma Glutamyl Transferase (U/L) &gt;3.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lactate Dehydrogenase (U/L) &gt;3.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (U/L) &gt;3.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein (g/dL) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein (g/dL) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin (g/dL) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin (g/dL) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea Nitrogen (mg/dL) &gt;1.3*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine (mg/dL) &gt;1.3*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urate (mg/dL) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL Cholesterol (mg/dL) &gt;1.2*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides (mg/dL) &gt;1.3*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium (mEq/L) &lt;0.95*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium (mEq/L) &gt;1.05*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mEq/L) &lt;0.9*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium (mEq/L) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride (mEq/L) &lt;0.9*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride (mEq/L) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium (mg/dL) &lt;0.9*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium (mg/dL) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (mEq/L) &lt;0.9*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bicarbonate (mEq/L) &gt;1.1*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (mg/dL) &lt;0.6*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose (mg/dL) &gt;1.5*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (U/L) &gt;2.0*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol (mg/dL)&gt;1.3*ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL Cholesterol (mg/dL) &lt;0.8*LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Specific Gravity (scalar) &lt;1.003</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Specific Gravity (scalar) &gt;1.030</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine pH (Scalar) &lt;4.5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine pH (Scalar) &gt;8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Glucose &gt;=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Ketones &gt;=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Protein &gt;=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Hemoglobin &gt;=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Nitrite &gt;=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Leukocyte Esterase &gt;=1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Erythrocytes (/HPF) &gt;=20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="41"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Leukocytes (/HPF) &gt;=20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Granular Casts (/LPF) &gt;1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Hyaline Casts (/LPF) &gt;1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urine Bacteria &gt;20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria</title>
        <description>A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to &gt;500 ms or &gt;60 ms change from screening ECG); data are presented below.</description>
        <time_frame>16 weeks</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria</title>
          <description>A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to &gt;500 ms or &gt;60 ms change from screening ECG); data are presented below.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QTcF Interval, Single Beat (msec) Value &gt;500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval, Single Beat (msec) Change From Screening &gt;60</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Categorization of Vital Signs Data Meeting Prespecified Criteria</title>
        <description>Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.</description>
        <time_frame>16 weeks</time_frame>
        <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Categorization of Vital Signs Data Meeting Prespecified Criteria</title>
          <description>Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.</description>
          <population>The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Number of Participants Analyzed refers to the number of participants who were evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diastolic Blood Pressure Value &lt;50mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure Increase From Baseline &gt;= 20mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure Decrease From Baseline &gt;= 20mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse Rate Value &lt;40 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse Rate Value &gt;120 bpm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure Value &lt;90mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure Increase From Baseline &gt;=30mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure Decrease From Baseline &gt;=30mmHg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination</title>
        <description>The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to &lt;18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.</description>
        <time_frame>4 weeks post-vaccination with Tdap (Week 12)</time_frame>
        <population>The immunogenicity sub-study analysis set included all participants who had completed 8 weeks of treatment and received Tdap vaccination. Number of Participants Analyzed refers to the number of participants evaluable in the analysis set at the specified visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received two PF-04965842-matching placebo tablets QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O3">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination</title>
          <description>The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to &lt;18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.</description>
          <population>The immunogenicity sub-study analysis set included all participants who had completed 8 weeks of treatment and received Tdap vaccination. Number of Participants Analyzed refers to the number of participants evaluable in the analysis set at the specified visit.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diphtheria IgG Antibody</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.00" lower_limit="6.32" upper_limit="30.99"/>
                    <measurement group_id="O2" value="6.51" lower_limit="2.31" upper_limit="18.34"/>
                    <measurement group_id="O3" value="34.61" lower_limit="6.96" upper_limit="172.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Filamentous Hemagglutinin IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.19" lower_limit="4.89" upper_limit="47.16"/>
                    <measurement group_id="O2" value="11.48" lower_limit="2.65" upper_limit="49.69"/>
                    <measurement group_id="O3" value="22.77" lower_limit="7.26" upper_limit="71.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fimbriae 2/3 IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" lower_limit="0.79" upper_limit="4.73"/>
                    <measurement group_id="O2" value="1.11" lower_limit="0.85" upper_limit="1.46"/>
                    <measurement group_id="O3" value="1.47" lower_limit="0.61" upper_limit="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertactin IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.03" lower_limit="14.67" upper_limit="199.03"/>
                    <measurement group_id="O2" value="15.60" lower_limit="5.77" upper_limit="42.14"/>
                    <measurement group_id="O3" value="60.18" lower_limit="12.79" upper_limit="283.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pertussis Toxin IgG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.94" lower_limit="1.95" upper_limit="24.71"/>
                    <measurement group_id="O2" value="10.17" lower_limit="4.71" upper_limit="21.94"/>
                    <measurement group_id="O3" value="33.16" lower_limit="5.04" upper_limit="218.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tetanus Toxoid IGG AB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.36" lower_limit="1.62" upper_limit="43.18"/>
                    <measurement group_id="O2" value="16.26" lower_limit="3.52" upper_limit="75.11"/>
                    <measurement group_id="O3" value="48.41" lower_limit="9.01" upper_limit="260.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma PF-04965842 Concentration at Week 8</title>
        <time_frame>2 hours pre-dose at Week 8</time_frame>
        <population>The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma PF-04965842 Concentration at Week 8</title>
          <population>The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.882" spread="26.350"/>
                    <measurement group_id="O2" value="32.33" spread="76.506"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma PF-04965842 Concentration at Week 12</title>
        <time_frame>2 hours post-dose at Week 12</time_frame>
        <population>The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PF-04965842 100mg QD</title>
            <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
          </group>
          <group group_id="O2">
            <title>PF-04965842 200mg QD</title>
            <description>Participants received two PF-04965842 100 mg tablets QD</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma PF-04965842 Concentration at Week 12</title>
          <population>The PK analysis included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Samples from site 1173 were excluded from the analysis.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="486.6" spread="403.69"/>
                    <measurement group_id="O2" value="1271" spread="1000.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 weeks</time_frame>
      <desc>The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received two PF-04965842-matching placebo tablets QD</description>
        </group>
        <group group_id="E2">
          <title>PF-04965842 100mg QD</title>
          <description>Participants received one PF-04965842 100 mg tablet and one matching placebo tablet QD</description>
        </group>
        <group group_id="E3">
          <title>PF-04965842 200mg QD</title>
          <description>Participants received two PF-04965842 100 mg tablets QD</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Dermatitis stopic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA v23.0</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="42" subjects_at_risk="96"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="95"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="95"/>
                <counts group_id="E3" events="27" subjects_affected="17" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="96"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="95"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="95"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="96"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="95"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="96"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="95"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="96"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="95"/>
                <counts group_id="E3" events="14" subjects_affected="10" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Protein urine</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="96"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="95"/>
                <counts group_id="E3" events="12" subjects_affected="8" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="95"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="95"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="96"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="95"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="96"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="95"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Dermatitis atopic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="96"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="95"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="94"/>
              </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/NCT03796676
org study id: B7451036
secondary id: JADE TEEN
secondary id: 2018-003804-37
nct id: NCT03796676
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of
      age with moderate to severe AD.
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to
      evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to <18 years of
      age with moderate to severe AD. Participants will be screened within 28 days prior to the
      first dose of study intervention to confirm study eligibility. Subjects must have
      moderate-severe AD involving at least 10% Body Surface Area (BSA); an Investigator Global
      Assessment (IGA) score of at least 3; an Eczema Area Severity Index (EASI) of at least 16 and
      Peak Pruritus Numerical Rating Score (NRS) of at least 4 on baseline/Day 1. Eligible subjects
      will be randomized at the Baseline/Day 1 visit. Approximately 225 participants will be
      randomized in a 1:1:1 ratio to receive once daily PF 04965842 at 200 mg, 100 mg, or placebo
      for 12 weeks. Randomization will be stratified by baseline disease severity (moderate [IGA =
      3] vs. severe [IGA = 4] AD). The investigational products will be administered QD for 12
      weeks. Background therapy (medicated and non-medicated topical therapy) must be applied BID
      for the duration of the treatment period. The co-primary efficacy endpoints are an IGA score
      of clear (0) or almost clear (1) with a reduction from baseline of greater than 2 points at
      Week 12 AND an at least 75% improvement of the EASI score (EASI-75) at week 12. Safety and
      efficacy assessments will be conducted at the investigator site by a clinical assessor
      blinded to treatment assignment. Scheduled clinic or telephone study visits for all subjects
      will occur at Screening, Baseline/Day 1, Day 8 (by phone), Day 15, Day 29, Day 43 (by phone),
      Day 57, Day 85 (End of treatment/Early termination), Day 113 (End of Study). Participants
      discontinuing early from the study will undergo a 4 week follow up period.

      This study includes an immunogenicity sub study integrated into the last 4 weeks of the main
      study treatment period. At Week 8, up to approximately 90 participants (up to approximately
      30 in each treatment arm) who have completed 8 weeks of treatment with study intervention
      will receive a tetanus, diphtheria and acellular pertussis combination vaccine (Tdap), and
      collection of blood samples for the evaluation of immunogenicity at Weeks 8 and 12.
      Participants of this sub study will complete all other protocol specified procedures in the
      main study.

      At the end of the 12 week study treatment, qualified participants completing the study will
      have the option to enter the long term extension (LTE) study B7451015.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 'Clear' (0) or 'Almost Clear' (1) and ≥2 Points Improvement From Baseline at Week 12
time frame: Baseline to Week 12
description: The IGA of Atopic Dermatitis (AD) was scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response ≥ 75% Improvement From Baseline at Week 12
time frame: Baseline to Week 12
description: The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of body surface area (BSA) affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants Achieving ≥4 Points Improvement From Baseline in Peak Pruritis Numeric Rating Scale (PP-NRS) for Severity of Pruritus at Weeks 2, 4 and 12
time frame: Baseline, Weeks 2, 4 and 12
description: PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
measure: Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) at Week 12
time frame: Baseline to Week 12
description: The PSAAD is a daily patient reported symptom diary presented as a 15 item questionnaire that includes 11 items developed to measure symptoms of AD, along with 4 additional items for exploratory and psychometric validation purposes (Sleep & Usual Activities Questions and Patient Global Impression of Severity & Patient Global Impression of Change Questions). Participants answer each question about skin condition based on a 24 hour recall. Each question was evaluated on a 11-point scale ranging from 0 to 10, where higher scores indicate more impact on skin condition.The PSAAD total score is calculated as the average of the responses to each of the 11 items and ranges from 0 (none) to 10 (extreme), where higher scores indicate worse severity of AD symptoms.
measure: Percentage of Participants Achieving IGA Response of 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline at All Scheduled Time Points Except Week 12
time frame: Baseline, Weeks 2, 4 and 8
description: The IGA of AD is scored on a 5-point scale (0-4), reflecting a global consideration of the erythema, induration and scaling. The overall severity of AD was assessed according to the 5-point scale: 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants Achieving EASI Response ≥ 75% Improvement From Baseline at All Scheduled Time Points Except Week 12
time frame: Baseline, Weeks 2, 4 and 8
description: The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants Achieving EASI Response ≥ 50% Improvement From Baseline
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants Achieving EASI Response ≥ 90% Improvement From Baseline
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants Achieving EASI Response =100% Improvement From Baseline
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
measure: Percent Change From Baseline in EASI Score
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The EASI quantifies the severity of AD based on both severity of lesion clinical signs and the percent of BSA affected. The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of AD. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants Achieving ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus at All Scheduled Time Points Other Than Weeks 2, 4 and 12
time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
description: PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10). Participants who withdrew from the study were counted as non-responder.
measure: Time to First Achieve ≥4 Points Improvement From Baseline in PP-NRS for Severity of Pruritus
time frame: Baseline to Week 16
description: PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
measure: Percent Change From Baseline in PP-NRS for Severity of Pruritus
time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15
description: PP-NRS assesses the severity of itch (pruritus) due to AD. Participants were asked to assess their worst itching due to AD on an NRS anchored by the terms "no itch" (0) and "worst itch imaginable" (10).
measure: Change From Baseline in Percentage Body Surface Area (BSA)
time frame: Baseline, Weeks 2, 4, 8 and 12
description: BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
measure: Percent Change From Baseline in Percentage BSA
time frame: Baseline, Weeks 2, 4, 8 and 12
description: BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
measure: Percentage of Participants Achieving Percentage BSA < 5% at Week 12
time frame: Baseline to Week 12
description: BSA efficacy is derived from the sum of the BSA in handprints across 4 body regions assessed as part of the EASI assessment. Handprint refers to that of each individual participant for their own measurement. The BSA efficacy ranges from 0 to 100%, with higher values representing greater severity of AD. The percentage BSA ranges from 0 to 100, with higher scores representing greater severity of AD. Since the scalp, palms, and soles were excluded from the BSA (efficacy) assessment, the maximum possible percentage BSA was less than 100.
measure: Percentage of Participants Achieving Scoring Atopic Dermatitis (SCORAD) Response ≥ 50% Improvement From Baseline
time frame: Baseline, Weeks 2, 4, 8 and 12
description: SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
measure: Percentage of Participants Achieving SCORAD Response ≥ 75% Improvement From Baseline
time frame: Baseline, Weeks 2, 4, 8 and 12
description: SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
measure: Change From Baseline in SCORAD Total Score
time frame: Baseline, Weeks 2, 4, 8 and 12
description: SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
measure: Percent Change From Baseline in SCORAD Total Score
time frame: Baseline, Weeks 2, 4, 8 and 12
description: SCORAD is a validated scoring index for AD,which combines extent (0-100),severity (0-18),and subjective symptoms (0-20) based on pruritus and sleep loss,each scored (0-10). Extent,denoted as A,is measured by BSA affected by AD as a percentage of the whole BSA.The score for each body region is added up to determine A (maximum of 100).Severity, denoted as B,consists of the severity of several signs.Each is assessed as none(0),mild(1),moderate(2) or severe(3).The severity scores are added together to give B (maximum of 18).Subjective symptoms,denoted as C,are each scored by the participant using a NRS where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness).These scores are added to give 'C' (maximum of 20).SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103).Higher values of SCORAD represent worse outcome.
measure: Change From Baseline in SCORAD Subjective Visual Analogue Scale (VAS) of Sleep Loss
time frame: Baseline, Weeks 2, 4, 8 and 12
description: SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
measure: Percent Change From Baseline in SCORAD Subjective VAS of Sleep Loss
time frame: Baseline, Weeks 2, 4, 8 and 12
description: SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on pruritus and sleep loss, each scored (0-10). The SCORAD for an individual is calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (ie, itch and sleep loss) are each scored by the participant using a VAS where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleep loss). The value for each should reflect the average on a 10 point scale for the last 3 days/nights. Changes from baseline in SCORAD subjective assessments of itch were not evaluated. Only changes from baseline in SCORAD subjective assessments of sleep loss are presented below.
measure: Number of Days When a Corticosteroid Not Used up to Day 88
time frame: Baseline to Day 88
measure: Change From Baseline in Children's Dermatology Life Quality Index (DLQI)
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
measure: Percentage of Participants With ≥2.5 Points at Baseline and Achieving ≥2.5 Points Improvement From Baseline in Children's DLQI
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The DLQI is a general dermatology questionnaire that consists of 10 items to assess participant-reported health-related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment).The DLQI is a psychometrically valid and reliable instrument that has been translated into several languages, and the DLQI total scores have been shown to be responsive to change. The minimally important difference for the DLQI has been estimated as a 3-5 point change from baseline. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" and "not at all (0)". The score can range from 0 to 30. The higher values represent the worse dermatology life quality. Participants who withdrew from the study were counted as non-responder.
measure: Change From Baseline in Anxiety of Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
measure: Change From Baseline in Depression of HADS
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The HADS is a 14-item patient reported outcome (PRO) measure used to detect states of anxiety and depression over the past week. Seven of the items relate to anxiety and seven relate to depression. Each item is scored from 0 to 3 which means a person can score between 0 to 21 for either anxiety or depression. Higher values represent worse outcome.
measure: Change From Baseline in Patient-Oriented Eczema Measure (POEM)
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The POEM is a 7-item PRO measure used to assess the impact of AD over the past week. Each item is scored as "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28. The higher values represent more severe AD.
measure: Change From Baseline in Dermatitis Family Impact (DFI) at Week 12
time frame: Baseline to Week 12
description: The DFI is a validated 10-item measure filled out by the parent/caregiver of the patient used to assess the impact of the patient's eczema on the family. The instrument has a recall period of 7 days. Each item is scored as "very much (3)", "a lot (2)", "a little (1)" or "not at all (0)". The score can range from 0 to 30. The higher values represent the worse impact.
measure: Change From Baseline in Patient Global Assessment (PtGA)
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
measure: Percentage of Participants With ≥2 Points at Baseline and Achieving 'Clear' or 'Almost Clear' and ≥2 Points Improvement From Baseline in PtGA
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, "severe (4)", "moderate (3)", "mild (2)","almost clear (1)", and "clear (0)". The PtGA was completed as per schedule of activities.
measure: Change From Baseline in EuroQol Quality of Life 5-Dimension Youth Scale (EQ-5D-Y) VAS Score
time frame: Baseline, Weeks 2, 4, 8 and 12
description: The EQ-5D is a validated, standardized, generic instrument that is the most widely used preference based health related quality of life questionnaire in cost effectiveness and health technologies assessment. The EQ-5D-Y is a version of the instrument specifically developed and validated for use by youths aged 12 through 17 years. Components assess level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. Score scale for each domain ranges from 1 (minimum) to 3 (maximum), with higher scores indicating worse health condition. In addition, respondents use a vertical, graduated Visual Analogue Scale (VAS) to rate their own health between 0 (the worst) and 100 (the best health state he/she can imagine).
measure: Change From Baseline in Pediatric Functional Assessment of Chronic Illness Therapy Fatigue Scale (Peds-FACIT-F) at Week 12
time frame: Baseline to Week 12
description: The Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (none of the time) to 4 (all of the time). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score), with higher scores representing better overall health status (less fatigue). Changes from baseline at Week 12 are presented below. Changes from baseline at other scheduled time points were not evaluated.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
time frame: 16 weeks
description: An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: 16 weeks
description: A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
measure: Number of Participants Who Discontinued From the Study Due to TEAEs
time frame: 16 weeks
description: An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. TEAEs were AEs that occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator.
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
time frame: 16 weeks
description: Laboratory tests included hematology (including coagulation panel), clinical chemistry, lipid profile panel, and routine urinalysis. LLN is lower limit of normal. ULN is upper limit of normal.
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Prespecified Criteria
time frame: 16 weeks
description: A 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT intervals. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Reading of ECGs were performed by a central reader who has expertise reading and interpreting ECGs in adolescents. The QTcF interval is the only prespecified ECG criteria (Marked prolongation of the QTcF interval to >500 ms or >60 ms change from screening ECG); data are presented below.
measure: Categorization of Vital Signs Data Meeting Prespecified Criteria
time frame: 16 weeks
description: Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes.
measure: Fold Increase of Immunoglobulin G (IgG) Concentrations Against Specific Vaccine Antigens at 4 Weeks Post-Vaccination
time frame: 4 weeks post-vaccination with Tdap (Week 12)
description: The immunogenicity analysis was to evaluate the effect of abrocitinib on immunogenicity to a tetanus, diphtheria and pertussis combination vaccine (Tdap) vaccine in adolescent participants 12 to <18 years of age with moderate to severe AD. Participants who completed 8 weeks of treatment with study intervention received Tdap at Week 8, and had blood samples collected for the evaluation of immunogenicity to the vaccine at Weeks 8 and 12. The fold increase was defined as the ratio (post-vaccination: pre-vaccination) of concentration values. The geometric mean fold rise (GMFR) is presented below, and was calculated by first arithmetically averaging the logarithmically transformed ratio (post-vaccination: pre-vaccination) values, and then back transformation. A 95% CI for GMFR was constructed by back transformation of the CI for the logarithmically transformed GMFRs computed using the Student's t distribution.
measure: Plasma PF-04965842 Concentration at Week 8
time frame: 2 hours pre-dose at Week 8
measure: Plasma PF-04965842 Concentration at Week 12
time frame: 2 hours post-dose at Week 12
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
arm group label: PF-04965842 100 mg QD
arm group type: Experimental
description: active
arm group label: PF-04965842 200 mg QD
arm group type: Experimental
description: active
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
intervention type: Drug
intervention name: PF-04965842
description: 100 mg QD
arm group label: PF-04965842 100 mg QD
intervention type: Drug
intervention name: PF04965842
description: 200 mg QD
arm group label: PF-04965842 200 mg QD
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Australia
country: China
country: Czechia
country: Germany
country: Hungary
country: Italy
country: Japan
country: Latvia
country: Mexico
country: Poland
country: Spain
country: Taiwan
country: United Kingdom
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=B7451036
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Abrocitinib
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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reported events: 
certain agreements: 
point of contact: 