<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/NCT02187172</url>
  </required_header>
  <id_info>
    <org_study_id>820124</org_study_id>
    <nct_id>NCT02187172</nct_id>
  </id_info>
  <brief_title>Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)</brief_title>
  <acronym>VIP-U</acronym>
  <official_title>A PHASE IV, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFECTS OF USTEKINUMAB ON VASCULAR INFLAMMATION IN PSORIASIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Scientific Affairs, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab&#xD;
      (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers&#xD;
      in patients with moderate to severe psoriasis.&#xD;
&#xD;
      This study will look for systemic vascular inflammation in study participants with a test&#xD;
      called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The&#xD;
      study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in&#xD;
      blood samples, including markers of high cholesterol, cholesterol efflux function (the&#xD;
      ability of cholesterol to move in the body), metabolic factors, and inflammation.&#xD;
&#xD;
      The study will also examine the effects of ustekinumab compared to placebo on psoriasis&#xD;
      activity, severity and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 11, 2018</completion_date>
  <primary_completion_date type="Actual">September 11, 2018</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>A hybrid RCT (randomized controlled trial) crossover trial where all patients receive total of 52 weeks of active treatment following an RCT phase of 12 weeks (active treatment or placebo). Patients randomized to active treatment will receive additional 40 weeks of active treatment at end of RCT phase; patients randomized to placebo will receive 52 weeks of active treatment at end of RCT phase. Primary outcomes are assessed at end of the RCT phase (comparison of interventions in change from start of treatment) and at end of 52 weeks of active treatment (change from start of treatment).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Vascular Inflammation</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Ferritin</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: GlycA</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: IL-2ra</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: IL-12/23</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: IL-17a</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: IL-18</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: IL-6</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Inflammatory Biomarker Levels: IL-8</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Triglycerides</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Total Cholesterol</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: HDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: HDL Particle Size</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Large-HDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Small-HDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Medium-HDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: LDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: LDL Particle Size</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Small-LDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Large-LDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Very Large-LDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: VLDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: VLDL Triglycerides</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Small-VLDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Medium-VLDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Large-VLDL Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Apolipoprotein-B</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Lipid Biomarker Levels: Fetuin-A</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Metabolic Biomarker Levels: Adiponectin</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Metabolic Biomarker Levels: Leptin</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Metabolic Biomarker Levels: Insulin</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Metabolic Biomarker Levels: Glucose</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI75, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of change in psoriasis activity; 75% or greater reduction in PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI90, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of change in psoriasis activity; 90% or greater reduction in PASI score compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PGA clear/almost clear, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of psoriasis disease activity at measurement time points; Physician Global Assessment score &lt;1.5 (clear/almost clear)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient-Reported Outcomes: MEDFICTS</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MEDFICTS, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument, has been provided as part of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guidelines as a free tool to use for proper cardiovascular diet assessment. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of &lt;40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of &lt;7% of energy from saturated fat, &lt;30% of energy from total fat, and &lt;200 mg dietary cholesterol/day).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Patient-reported Physical Activity Assessments: IPAQ</measure>
    <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
    <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IPAQ, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Psoriasis</condition>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Ustekinumab (Stelara)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter. Patient will receive total of 52 weeks of ustekinumab (12 weeks during RCT phase, 40 weeks post RCT phase). The end of study is at Week 52 for this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator until week 12 (end of RCT phase). At week 12, ustekinumab will be administered according according to the same injection schedule as the active comparator arm for 52 weeks. Patient will receive total of 52 weeks of ustekinumab (0 weeks during RCT phase, 52 weeks post RCT phase). The end of study is at Week 64 for this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ustekinumab</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Ustekinumab (Stelara)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females 18 years of age and older.&#xD;
&#xD;
          2. Clinical diagnosis of psoriasis for at least 6 months as determined by subject&#xD;
             interview of his/her medical history and confirmation of diagnosis through physical&#xD;
             examination by Investigator.&#xD;
&#xD;
          3. Stable plaque psoriasis for at least 2 months before Screening and at Baseline (Week&#xD;
             0) as determined by subject interview of his/her medical history.&#xD;
&#xD;
          4. Moderate to severe psoriasis defined by ≥ 10 percent Body Surface Area (BSA)&#xD;
             involvement at the Baseline (Week 0) visit.&#xD;
&#xD;
          5. PASI score of ≥ 12 at the Baseline (Week 0) visit.&#xD;
&#xD;
          6. Subject is a candidate for systemic therapy and has active psoriasis despite prior&#xD;
             treatment with topical agents.&#xD;
&#xD;
          7. Women are eligible to participate in the study if they meet one of the following&#xD;
             criteria:&#xD;
&#xD;
               1. Women of childbearing potential who are willing to undergo periodic pregnancy&#xD;
                  testing during the study and agree to use at least one method of contraception&#xD;
                  throughout the study duration and for at least 15 weeks after the last dose of&#xD;
                  the study drug are eligible to participate.&#xD;
&#xD;
               2. Women who are postmenopausal (for at least one year), sterile, or hysterectomized&#xD;
                  are eligible to participate.&#xD;
&#xD;
               3. Women who have undergone tubal ligation are eligible to participate.&#xD;
&#xD;
               4. Women who agree to be sexually abstinent, defined as total abstinence from sexual&#xD;
                  intercourse, as a form of contraception, are eligible to participate.&#xD;
&#xD;
          8. Men are eligible to participate in the study if they meet one of the following&#xD;
             criteria:&#xD;
&#xD;
               1. Agree to use a proven birth control method during the study and for at least 15&#xD;
                  weeks after the last dose of the study drug.&#xD;
&#xD;
               2. Have a female partner who agrees to use at least one method of contraception&#xD;
                  throughout the study duration and for at least 15 weeks after the last dose of&#xD;
                  the study drug.&#xD;
&#xD;
               3. Have a female partner who is postmenopausal (for at least one year), sterile, or&#xD;
                  hysterectomized;&#xD;
&#xD;
               4. Have a female partner who has undergone tubal ligation,&#xD;
&#xD;
               5. Agree to be sexually abstinent, defined as total abstinence from sexual&#xD;
                  intercourse, as a form of contraception.&#xD;
&#xD;
          9. Subject is judged to be in good general health as determined by the Principal&#xD;
             Investigator based upon the results of medical history, laboratory profile, physical&#xD;
             examination, and 12-lead electrocardiogram (ECG) performed at screening.&#xD;
&#xD;
         10. Able and willing to give written informed consent and to comply with requirements of&#xD;
             this study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous adverse event following exposure to an IL-12/IL-23 antagonist that led to&#xD;
             discontinuation of therapy and contraindicates future treatment.&#xD;
&#xD;
          2. Previous lack of response to an IL-12/IL-23 antagonist that led to discontinuation of&#xD;
             therapy.&#xD;
&#xD;
          3. Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis,&#xD;
             medication-induced or medication-exacerbated psoriasis, or new onset guttate&#xD;
             psoriasis.&#xD;
&#xD;
          4. Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or&#xD;
             viral) that may interfere with evaluation of psoriasis.&#xD;
&#xD;
          5. Cannot avoid UVB phototherapy or Excimer laser for at least 14 days prior to the&#xD;
             Baseline (Week 0) visit and during the study.&#xD;
&#xD;
          6. Cannot avoid psoralen-UVA phototherapy for at least 30 days prior to the Baseline&#xD;
             (Week 0) visit and during the study.&#xD;
&#xD;
          7. Cannot discontinue systemic therapies for the treatment of psoriasis, or systemic&#xD;
             therapies known to improve psoriasis, during the study:&#xD;
&#xD;
               -  Systemic therapies must be discontinued at least 30 days prior to the Baseline&#xD;
                  (Week 0) visit except for biologics.&#xD;
&#xD;
                    -  All biologics, except ustekinumab, must be discontinued for at least 90 days&#xD;
                       prior to Baseline (Week 0).&#xD;
&#xD;
                    -  Any IL-12/IL-23 antagonist (e.g., ustekinumab, briakinumab) must be&#xD;
                       discontinued for at least 180 days prior to Baseline (Week 0).&#xD;
&#xD;
               -  Investigational agents must be discontinued at least 30 days or 5 half-lives&#xD;
                  (whichever is longer) prior to the Baseline (Week 0) visit.&#xD;
&#xD;
          8. Subject is taking or requires oral or injectable corticosteroids during the study.&#xD;
             Inhaled corticosteroids for stable medical conditions are allowed.&#xD;
&#xD;
          9. Poorly controlled medical condition, such as unstable ischemic heart disease,&#xD;
             cerebrovascular accident or myocardial infarction within the prior 6 months,&#xD;
             psychiatric disease requiring frequent hospitalization, and any other condition,&#xD;
             which, in the opinion of the Investigator, would put the subject at risk by&#xD;
             participation in the study.&#xD;
&#xD;
         10. History of diabetes mellitus, type 1 or type 2 with the exception that patients with&#xD;
             type 2 diabetes may be enrolled if the duration of diabetes is &lt;10 years and HbA1c is&#xD;
             &lt;7.0%.&#xD;
&#xD;
         11. Uncontrolled hypertension, with measured systolic blood pressure &gt;180 mmHg or&#xD;
             diastolic blood pressure &gt;90 mmHg&#xD;
&#xD;
         12. Subject has infection or risk factors for severe infections, for example:&#xD;
&#xD;
               -  Positive serology or known history of HIV, hepatitis B or C, or other severe,&#xD;
                  recurrent, or persistent infections;&#xD;
&#xD;
               -  Excessive immunosuppression or other factors associated with it, including human&#xD;
                  immunodeficiency virus infection;&#xD;
&#xD;
               -  Active tuberculosis (TB) disease;&#xD;
&#xD;
               -  Evidence of latent TB infection demonstrated by positive Quantiferon-GOLD result;&#xD;
                  except if prophylactic treatment for TB, as recommended by local guidelines, is&#xD;
                  initiated prior to administration of study drug or if there is documentation that&#xD;
                  the subject has received prophylactic treatment for TB within 3 years prior to&#xD;
                  the first administration of study agent.&#xD;
&#xD;
               -  Any other significant infection requiring hospitalization or intravenous (IV)&#xD;
                  antibiotics in the month prior to Baseline;&#xD;
&#xD;
               -  Infection requiring treatment with oral or parenteral (other than IV) antibiotics&#xD;
                  within 14 days prior to Baseline;&#xD;
&#xD;
               -  Subject has received vaccination with Bacille Calmette-Guerin (BCG) within 365&#xD;
                  days prior to Screening or will receive BCG vaccination during study&#xD;
                  participation including up to 12 months after the last dose of the study drug;&#xD;
&#xD;
               -  Subject has received vaccination with a live viral agent 30 days prior to&#xD;
                  Screening or will require a live vaccination during study participation including&#xD;
                  up to 3 months after the last dose of study drug.&#xD;
&#xD;
         13. Subject has history of hematological or solid malignancy within the past five years&#xD;
             other than successfully treated basal cell carcinoma, non-metastatic cutaneous&#xD;
             squamous cell carcinoma or cervical carcinoma in situ.&#xD;
&#xD;
         14. Female subject who is pregnant or breast-feeding or considering becoming pregnant&#xD;
             during the study.&#xD;
&#xD;
         15. Male subject who is considering fathering a child during the study.&#xD;
&#xD;
         16. Screening clinical laboratory analyses showing any of the following abnormal results:&#xD;
&#xD;
               -  Hemoglobin (Hgb) &lt; 10 g/dL in females or &lt;12 g/dL in males;&#xD;
&#xD;
               -  White blood cell (WBC) count &lt;2.5 x 109/L&#xD;
&#xD;
                  o Subject can be included if WBC count is &lt;2.5 x 109/L and absolute neutrophil&#xD;
                  count (ANC) is &gt;1000 cells / mm3.&#xD;
&#xD;
               -  WBC count &gt; 15 x 109/L;&#xD;
&#xD;
               -  Platelet count &lt; 100 x 109/L;&#xD;
&#xD;
               -  Serum creatinine &gt;1.6 mg/dL (&gt;141 µmol/L);&#xD;
&#xD;
               -  Serum aspartate transaminase (AST) or alanine transaminase (ALT) &gt;2.5 upper&#xD;
                  limits of normal (ULN);&#xD;
&#xD;
               -  Serum total bilirubin ≥2 mg/dL (≥26 µmol/L)&#xD;
&#xD;
         17. Recent history of substance abuse or psychiatric illness that could preclude&#xD;
             compliance with the protocol.&#xD;
&#xD;
         18. History of any substance abuse within 365 days of screening visit&#xD;
&#xD;
         19. Alcohol use &gt;14 drinks per week at the screening visit or within 30 days of the&#xD;
             screening period&#xD;
&#xD;
         20. If subject is on cholesterol-lowering medication (e.g. statin), dose and form of&#xD;
             medication must be stable for 90 days prior to week 0 and remain stable throughout the&#xD;
             duration of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel M Gelfand, MD, MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <results_first_submitted>June 17, 2019</results_first_submitted>
  <results_first_submitted_qc>August 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2019</results_first_posted>
  <last_update_submitted>August 14, 2019</last_update_submitted>
  <last_update_submitted_qc>August 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Vascular Inflammation</keyword>
  <keyword>Lipid Biomarkers</keyword>
  <keyword>FDG-PET/CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Psoriasis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ustekinumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT02187172/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ustekinumab</title>
          <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12 (randomized controlled trial (RCT) phase). Continue to receive ustekinumab for additional 40 weeks for a total of 52 weeks of ustekinumab. The end of study is at Week 52 for this arm.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Randomized to receive Placebo from day 0 until week 12 (RCT phase). Receive ustekinumab from week 12 until week 64 for a total of 52 weeks of ustekinumab. The end of study is at Week 64 for this arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>RCT Phase Completed</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ustekinumab (Stelara)</title>
          <description>Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter.&#xD;
Ustekinumab</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator.&#xD;
Ustekinumab&#xD;
Placebo</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="43"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.45" spread="13.6"/>
                    <measurement group_id="B2" value="45.33" spread="12.76"/>
                    <measurement group_id="B3" value="42.33" spread="13.38"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.24" spread="7.95"/>
                    <measurement group_id="B2" value="33.32" spread="6.29"/>
                    <measurement group_id="B3" value="33.28" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical History</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Arthritis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coronary Artery Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperlipidemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stroke</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Statin Use</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Surface Area (BSA)</title>
          <units>percentage of total body surface area</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.18" spread="17.51"/>
                    <measurement group_id="B2" value="23.71" spread="15.58"/>
                    <measurement group_id="B3" value="24.98" spread="16.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psoriasis Area Severity Index (PASI) score</title>
          <description>Psoriasis Area and Severity Index (PASI) combines the assessment of the severity of lesions and the area affected into a single score with range 0 (no disease) to 72 maximal disease.</description>
          <units>composite score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.03" spread="7.47"/>
                    <measurement group_id="B2" value="19.82" spread="7.64"/>
                    <measurement group_id="B3" value="19.93" spread="7.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physician Global Assessment (PGA)</title>
          <description>The Physician Global Assessment (PGA) is an average assessment of all psoriatic lesions based on erythema, scale, and induration with score range 0 (no disease/clear) to 5 (maximal disease).</description>
          <units>calculated score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.5" spread="0.57"/>
                    <measurement group_id="B2" value="3.38" spread="0.8"/>
                    <measurement group_id="B3" value="3.44" spread="0.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psoriasis duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.45" spread="11.02"/>
                    <measurement group_id="B2" value="20.29" spread="14.41"/>
                    <measurement group_id="B3" value="18.13" spread="12.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psoriasis treatment history</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Biologics</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systemics</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phototherapy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Psoriatic Arthritis (PsA) present</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at PsA diagnosis</title>
          <population>Only applicable in patients with psoriatic arthritis</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="5"/>
                    <count group_id="B3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22" spread="0"/>
                    <measurement group_id="B2" value="43.6" spread="14.33"/>
                    <measurement group_id="B3" value="40" spread="15.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Vascular Inflammation</title>
        <description>Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vascular Inflammation</title>
          <description>Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>TBR max</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1015" spread="0.0465"/>
                    <measurement group_id="O2" value="0.1442" spread="0.0137"/>
                    <measurement group_id="O3" value="-0.0151" spread="0.0353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.2456</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0700</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3873</ci_lower_limit>
            <ci_upper_limit>-0.1040</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6718</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.0151</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0353</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0867</ci_lower_limit>
            <ci_upper_limit>0.0565</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.83" spread="26.30"/>
                    <measurement group_id="O2" value="75.80" spread="37.19"/>
                    <measurement group_id="O3" value="6.65" spread="22.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1159</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-64.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>44.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-115.83</ci_lower_limit>
            <ci_upper_limit>25.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7666</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>22.24</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.41</ci_lower_limit>
            <ci_upper_limit>51.72</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.36" spread="18.39"/>
                    <measurement group_id="O2" value="60.53" spread="24.76"/>
                    <measurement group_id="O3" value="-1.99" spread="14.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0115</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-80.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>30.46</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-142.55</ci_lower_limit>
            <ci_upper_limit>-19.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8883</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.99</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>14.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.58</ci_lower_limit>
            <ci_upper_limit>26.59</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2886.57" spread="2851.16"/>
                    <measurement group_id="O2" value="140.64" spread="1108.54"/>
                    <measurement group_id="O3" value="-1974.63" spread="1659.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3472</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3027.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3180.58</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9465.95</ci_lower_limit>
            <ci_upper_limit>3411.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Combined ustekinumab and placebo groups for active treatment period analysis.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2416</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1974.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1659.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5336.30</ci_lower_limit>
            <ci_upper_limit>1387.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Ferritin</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Ferritin</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.32" spread="39.16"/>
                    <measurement group_id="O2" value="-32.97" spread="27.40"/>
                    <measurement group_id="O3" value="47.00" spread="35.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6742</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>20.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>24.75</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-78.03</ci_lower_limit>
            <ci_upper_limit>119.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1979</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>47.00</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>35.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.63</ci_lower_limit>
            <ci_upper_limit>11963</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7687.80" spread="7389.00"/>
                    <measurement group_id="O2" value="196.49" spread="203.34"/>
                    <measurement group_id="O3" value="-3782.54" spread="4073.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3173</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7884.29</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7780.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23634.67</ci_lower_limit>
            <ci_upper_limit>7566.10</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3591</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3782.54</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4073.25</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12035.72</ci_lower_limit>
            <ci_upper_limit>4470.64</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="2.25"/>
                    <measurement group_id="O2" value="0.04" spread="0.95"/>
                    <measurement group_id="O3" value="-1.09" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9767</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.22</ci_lower_limit>
            <ci_upper_limit>5.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3205</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.09</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.29</ci_lower_limit>
            <ci_upper_limit>1.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.66" spread="15.51"/>
                    <measurement group_id="O2" value="0.13" spread="12.09"/>
                    <measurement group_id="O3" value="-7.24" spread="11.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4632</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-14.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>19.96</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-55.19</ci_lower_limit>
            <ci_upper_limit>25.61</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5316</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.47</ci_lower_limit>
            <ci_upper_limit>15.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.51"/>
                    <measurement group_id="O2" value="0.68" spread="0.44"/>
                    <measurement group_id="O3" value="-0.67" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1928</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.68</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.27</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0580</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.34</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.36</ci_lower_limit>
            <ci_upper_limit>0.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: GlycA</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: GlycA</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>umol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.70" spread="7.42"/>
                    <measurement group_id="O2" value="3.44" spread="8.76"/>
                    <measurement group_id="O3" value="-8.35" spread="8.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7185</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.24</ci_lower_limit>
            <ci_upper_limit>18.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3271</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.35</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.40</ci_lower_limit>
            <ci_upper_limit>8.69</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.38"/>
                    <measurement group_id="O2" value="0.60" spread="0.34"/>
                    <measurement group_id="O3" value="-0.31" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3124</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.56</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0106</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.54</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: IL-2ra</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: IL-2ra</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-79.07" spread="28.51"/>
                    <measurement group_id="O2" value="-8.31" spread="15.48"/>
                    <measurement group_id="O3" value="71.72" spread="132.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0408</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-70.76</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>33.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-138.42</ci_lower_limit>
            <ci_upper_limit>-3.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5926</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>71.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>132.87</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-197.50</ci_lower_limit>
            <ci_upper_limit>340.93</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: IL-12/23</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: IL-12/23</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196.84" spread="43.59"/>
                    <measurement group_id="O2" value="5.35" spread="4.63"/>
                    <measurement group_id="O3" value="171.21" spread="20.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>191.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>46.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.18</ci_lower_limit>
            <ci_upper_limit>284.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>171.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>20.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>130.08</ci_lower_limit>
            <ci_upper_limit>212.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: IL-17a</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: IL-17a</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.46" spread="0.39"/>
                    <measurement group_id="O2" value="1.17" spread="0.94"/>
                    <measurement group_id="O3" value="-1.15" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0110</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.98</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.62</ci_lower_limit>
            <ci_upper_limit>-0.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0008</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.79</ci_lower_limit>
            <ci_upper_limit>-0.51</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: IL-18</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: IL-18</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="301.21" spread="483.77"/>
                    <measurement group_id="O2" value="456.52" spread="487.49"/>
                    <measurement group_id="O3" value="-407.43" spread="180.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8227</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-155.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>688.28</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1548.66</ci_lower_limit>
            <ci_upper_limit>1238.04</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0302</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-407.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>180.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-773.57</ci_lower_limit>
            <ci_upper_limit>-41.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: IL-6</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: IL-6</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" spread="0.22"/>
                    <measurement group_id="O2" value="0.02" spread="0.33"/>
                    <measurement group_id="O3" value="-0.38" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2333</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>-0.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.25</ci_lower_limit>
            <ci_upper_limit>0.32</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0713</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.21</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.80</ci_lower_limit>
            <ci_upper_limit>0.03</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Inflammatory Biomarker Levels: IL-8</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inflammatory Biomarker Levels: IL-8</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" spread="3.35"/>
                    <measurement group_id="O2" value="19.33" spread="16.02"/>
                    <measurement group_id="O3" value="-2.23" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2869</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-16.87</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>15.62</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.48</ci_lower_limit>
            <ci_upper_limit>14.75</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1988</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.23</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.69</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Triglycerides</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Triglycerides</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" spread="9.42"/>
                    <measurement group_id="O2" value="-1.58" spread="8.70"/>
                    <measurement group_id="O3" value="10.55" spread="8.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8744</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.09</ci_lower_limit>
            <ci_upper_limit>28.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2093</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>10.55</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.26</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.18</ci_lower_limit>
            <ci_upper_limit>27.29</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Total Cholesterol</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Total Cholesterol</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.57" spread="5.04"/>
                    <measurement group_id="O2" value="-6.63" spread="5.45"/>
                    <measurement group_id="O3" value="-0.79" spread="4.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0135</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>19.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.21</ci_lower_limit>
            <ci_upper_limit>34.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8499</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.14</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.19</ci_lower_limit>
            <ci_upper_limit>7.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24" spread="1.31"/>
                    <measurement group_id="O2" value="-1.42" spread="1.46"/>
                    <measurement group_id="O3" value="1.92" spread="1.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0693</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.66</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.96</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.30</ci_lower_limit>
            <ci_upper_limit>7.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1841</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.96</ci_lower_limit>
            <ci_upper_limit>4.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: HDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: HDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.69"/>
                    <measurement group_id="O2" value="-1.27" spread="0.77"/>
                    <measurement group_id="O3" value="0.91" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2305</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>3.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2189</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.91</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.72</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.53</ci_lower_limit>
            <ci_upper_limit>2.37</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: HDL Particle Size</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: HDL Particle Size</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nm</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.05"/>
                    <measurement group_id="O2" value="0.19" spread="0.10"/>
                    <measurement group_id="O3" value="0.17" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3212</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>0.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0137</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Large-HDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Large-HDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="0.38"/>
                    <measurement group_id="O2" value="0.33" spread="0.47"/>
                    <measurement group_id="O3" value="0.51" spread="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8383</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>0.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.60</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.09</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1651</p_value>
            <method>Regression, Logistic</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.22</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Small-HDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Small-HDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="1.15"/>
                    <measurement group_id="O2" value="-2.52" spread="1.25"/>
                    <measurement group_id="O3" value="0.21" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1502</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.94</ci_lower_limit>
            <ci_upper_limit>5.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8054</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.49</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Medium-HDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Medium-HDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.56" spread="1.21"/>
                    <measurement group_id="O2" value="0.81" spread="1.17"/>
                    <measurement group_id="O3" value="0.17" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4235</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.69</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.79</ci_lower_limit>
            <ci_upper_limit>2.05</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8653</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.17</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.80</ci_lower_limit>
            <ci_upper_limit>2.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="1.26"/>
                    <measurement group_id="O2" value="1.14" spread="1.43"/>
                    <measurement group_id="O3" value="0.77" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5580</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.89</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.95</ci_lower_limit>
            <ci_upper_limit>2.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4454</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.00</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.25</ci_lower_limit>
            <ci_upper_limit>2.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.52" spread="4.21"/>
                    <measurement group_id="O2" value="-8.84" spread="5.25"/>
                    <measurement group_id="O3" value="-2.92" spread="4.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0027</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>21.37</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.67</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.86</ci_lower_limit>
            <ci_upper_limit>34.87</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4775</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.92</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.17</ci_lower_limit>
            <ci_upper_limit>5.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: LDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: LDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.67" spread="46.44"/>
                    <measurement group_id="O2" value="-118.11" spread="52.45"/>
                    <measurement group_id="O3" value="-31.89" spread="41.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0021</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>230.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>69.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>89.47</ci_lower_limit>
            <ci_upper_limit>372.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4493</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-31.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>41.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-116.40</ci_lower_limit>
            <ci_upper_limit>52.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: LDL Particle Size</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: LDL Particle Size</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="0.11"/>
                    <measurement group_id="O2" value="0.15" spread="0.13"/>
                    <measurement group_id="O3" value="0.03" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8008</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.30</ci_lower_limit>
            <ci_upper_limit>0.38</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8068</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.19</ci_lower_limit>
            <ci_upper_limit>0.24</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Small-LDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Small-LDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.36" spread="38.72"/>
                    <measurement group_id="O2" value="-22.61" spread="40.61"/>
                    <measurement group_id="O3" value="4.68" spread="33.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4079</p_value>
            <method>Regression, Logistic</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>46.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>56.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-66.65</ci_lower_limit>
            <ci_upper_limit>160.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8907</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.68</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>33.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-63.91</ci_lower_limit>
            <ci_upper_limit>73.28</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Large-LDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Large-LDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.95" spread="26.87"/>
                    <measurement group_id="O2" value="21.95" spread="41.87"/>
                    <measurement group_id="O3" value="-24.76" spread="32.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8866</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>48.81</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-91.80</ci_lower_limit>
            <ci_upper_limit>105.81</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4527</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-24.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>32.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-90.78</ci_lower_limit>
            <ci_upper_limit>41.30</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Very Large-LDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Very Large-LDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.95" spread="45.38"/>
                    <measurement group_id="O2" value="-100.74" spread="48.29"/>
                    <measurement group_id="O3" value="-29.16" spread="38.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0056</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>194.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>66.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>60.61</ci_lower_limit>
            <ci_upper_limit>328.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4478</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-29.16</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>38.01</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-106.17</ci_lower_limit>
            <ci_upper_limit>47.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.19" spread="2.19"/>
                    <measurement group_id="O2" value="0.04" spread="1.69"/>
                    <measurement group_id="O3" value="1.50" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2704</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.81</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.55</ci_lower_limit>
            <ci_upper_limit>8.83</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2950</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.41</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.36</ci_lower_limit>
            <ci_upper_limit>4.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: VLDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: VLDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.32" spread="4.85"/>
                    <measurement group_id="O2" value="7.42" spread="4.34"/>
                    <measurement group_id="O3" value="-0.11" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0149</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-16.74</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.57</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.03</ci_lower_limit>
            <ci_upper_limit>-3.45</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9734</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.37</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.93</ci_lower_limit>
            <ci_upper_limit>6.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: VLDL Triglycerides</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: VLDL Triglycerides</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.88" spread="8.85"/>
                    <measurement group_id="O2" value="4.33" spread="7.57"/>
                    <measurement group_id="O3" value="11.14" spread="7.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4384</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-9.21</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.76</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.03</ci_lower_limit>
            <ci_upper_limit>14.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1373</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>11.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.72</ci_lower_limit>
            <ci_upper_limit>25.99</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Small-VLDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Small-VLDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.84" spread="2.72"/>
                    <measurement group_id="O2" value="9.87" spread="5.27"/>
                    <measurement group_id="O3" value="-0.50" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0097</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-15.71</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.77</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.39</ci_lower_limit>
            <ci_upper_limit>-4.03</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8119</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.69</ci_lower_limit>
            <ci_upper_limit>3.70</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Medium-VLDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Medium-VLDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.50" spread="2.98"/>
                    <measurement group_id="O2" value="-3.84" spread="3.50"/>
                    <measurement group_id="O3" value="-1.86" spread="2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9415</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.57</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.91</ci_lower_limit>
            <ci_upper_limit>9.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4485</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.77</ci_lower_limit>
            <ci_upper_limit>3.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.89" spread="3.33"/>
                    <measurement group_id="O2" value="-2.97" spread="3.98"/>
                    <measurement group_id="O3" value="0.38" spread="2.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9880</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.08</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.16</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.37</ci_lower_limit>
            <ci_upper_limit>10.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8836</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.86</ci_lower_limit>
            <ci_upper_limit>5.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Large-VLDL Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Large-VLDL Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.86"/>
                    <measurement group_id="O2" value="0.57" spread="0.99"/>
                    <measurement group_id="O3" value="2.30" spread="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8321</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.91</ci_lower_limit>
            <ci_upper_limit>2.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0394</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.12</ci_lower_limit>
            <ci_upper_limit>4.48</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.86" spread="25.89"/>
                    <measurement group_id="O2" value="-101.79" spread="36.04"/>
                    <measurement group_id="O3" value="-2.97" spread="25.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0012</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>152.68</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>43.76</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>64.07</ci_lower_limit>
            <ci_upper_limit>241.23</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9085</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>25.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-55.04</ci_lower_limit>
            <ci_upper_limit>49.09</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>unitless (see description)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.03"/>
                    <measurement group_id="O2" value="0.03" spread="0.03"/>
                    <measurement group_id="O3" value="0.04" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1792</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2559</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.03</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Apolipoprotein-B</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Apolipoprotein-B</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.09"/>
                    <measurement group_id="O2" value="-0.04" spread="0.09"/>
                    <measurement group_id="O3" value="0.10" spread="0.06"/>
                  </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>0.2453</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.13</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.11</ci_lower_limit>
            <ci_upper_limit>0.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1087</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.10</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Lipid Biomarker Levels: Fetuin-A</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Lipid Biomarker Levels: Fetuin-A</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.22" spread="29.47"/>
                    <measurement group_id="O2" value="-38.21" spread="56.05"/>
                    <measurement group_id="O3" value="-49.56" spread="27.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4368</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>48.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>61.62</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-76.31</ci_lower_limit>
            <ci_upper_limit>173.16</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0833</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-49.56</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>27.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-105.97</ci_lower_limit>
            <ci_upper_limit>6.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Metabolic Biomarker Levels: Adiponectin</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Metabolic Biomarker Levels: Adiponectin</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>ug/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.79"/>
                    <measurement group_id="O2" value="0.32" spread="0.77"/>
                    <measurement group_id="O3" value="0.38" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8036</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.11</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.52</ci_lower_limit>
            <ci_upper_limit>1.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4608</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.38</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.65</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Metabolic Biomarker Levels: Leptin</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Metabolic Biomarker Levels: Leptin</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8022.19" spread="2576.52"/>
                    <measurement group_id="O2" value="4701.61" spread="2184.57"/>
                    <measurement group_id="O3" value="6926.25" spread="2257.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3370</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3320.58</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3414.90</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3592.52</ci_lower_limit>
            <ci_upper_limit>10233.67</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0040</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>6926.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2257.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2351.43</ci_lower_limit>
            <ci_upper_limit>11501.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Metabolic Biomarker Levels: Insulin</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Metabolic Biomarker Levels: Insulin</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.19" spread="116.40"/>
                    <measurement group_id="O2" value="105.13" spread="51.42"/>
                    <measurement group_id="O3" value="-7.96" spread="85.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6042</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-68.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>131.90</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-335.97</ci_lower_limit>
            <ci_upper_limit>198.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9267</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>85.98</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-182.18</ci_lower_limit>
            <ci_upper_limit>166.26</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Metabolic Biomarker Levels: Glucose</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Metabolic Biomarker Levels: Glucose</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.41" spread="3.34"/>
                    <measurement group_id="O2" value="-1.79" spread="4.02"/>
                    <measurement group_id="O3" value="3.41" spread="3.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4226</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.28</ci_lower_limit>
            <ci_upper_limit>14.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3270</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>3.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.54</ci_lower_limit>
            <ci_upper_limit>10.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).</description>
          <population>The number of subjects analyzed reflect patient dropouts and availability of analyzable samples. The two arms in the RCT period are compared in Statistical Analysis 1. The composite &quot;Total&quot; group is used to assess 52 weeks of active treatment at end of study compared to baseline and is analyzed separately in Statistical Analysis 2.</population>
          <units>unitless (see description)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.37"/>
                    <measurement group_id="O2" value="0.55" spread="0.49"/>
                    <measurement group_id="O3" value="-0.07" spread="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7507</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.49</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.52</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.56</ci_lower_limit>
            <ci_upper_limit>2.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global change from baseline after 52 weeks of active treatment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9348</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.07</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.89</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.88</ci_lower_limit>
            <ci_upper_limit>1.73</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI75, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of change in psoriasis activity; 75% or greater reduction in PASI score compared to baseline.</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI75, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of change in psoriasis activity; 75% or greater reduction in PASI score compared to baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="28"/>
                  </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>0.0005</p_value>
            <method>Chi-squared</method>
            <param_type>Difference of proportions</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% CI of proportion achieving PASI75 at end of study</non_inferiority_desc>
            <param_type>Proportion</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI90, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of change in psoriasis activity; 90% or greater reduction in PASI score compared to baseline.</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI90, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of change in psoriasis activity; 90% or greater reduction in PASI score compared to baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="19"/>
                  </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>0.0016</p_value>
            <method>Chi-squared</method>
            <param_type>Difference of proportions</param_type>
            <param_value>0.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.20</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% CI of proportion achieving PASI90 at end of study</non_inferiority_desc>
            <param_type>Proportion</param_type>
            <param_value>0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PGA clear/almost clear, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of psoriasis disease activity at measurement time points; Physician Global Assessment score &lt;1.5 (clear/almost clear)</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PGA clear/almost clear, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
Binary measure of psoriasis disease activity at measurement time points; Physician Global Assessment score &lt;1.5 (clear/almost clear)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison during RCT period for binary Physician Global Assessment</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0005</p_value>
            <method>Chi-squared</method>
            <param_type>Difference of proportions</param_type>
            <param_value>0.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.29</ci_lower_limit>
            <ci_upper_limit>0.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>95% CI of proportion achieving PGA clear/almost clear at end of study</non_inferiority_desc>
            <param_type>Proportion</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.30</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient-Reported Outcomes: MEDFICTS</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MEDFICTS, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument, has been provided as part of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guidelines as a free tool to use for proper cardiovascular diet assessment. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of &lt;40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of &lt;7% of energy from saturated fat, &lt;30% of energy from total fat, and &lt;200 mg dietary cholesterol/day).</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient-Reported Outcomes: MEDFICTS</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MEDFICTS, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument, has been provided as part of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guidelines as a free tool to use for proper cardiovascular diet assessment. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of &lt;40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of &lt;7% of energy from saturated fat, &lt;30% of energy from total fat, and &lt;200 mg dietary cholesterol/day).</description>
          <units>MEDFICTS score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.68" spread="3.97"/>
                    <measurement group_id="O2" value="-14.00" spread="4.98"/>
                    <measurement group_id="O3" value="8.32" spread="6.30"/>
                  </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>0.1944</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.42</ci_lower_limit>
            <ci_upper_limit>21.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0011</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-12.33</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.50</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.40</ci_lower_limit>
            <ci_upper_limit>-5.25</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Patient-reported Physical Activity Assessments: IPAQ</title>
        <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IPAQ, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.</description>
        <time_frame>Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ustekinumab (RCT Period)</title>
            <description>Randomized to receive Ustekinumab (Stelara) from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O2">
            <title>Placebo (RCT Period)</title>
            <description>Randomized to receive Placebo from day 0 until week 12. Outcome measures reflect changes at week 12 compared to baseline.</description>
          </group>
          <group group_id="O3">
            <title>Total (Active Treatment Period)</title>
            <description>Combined ustekinumab and placebo groups for active treatment period analysis. Outcome measures reflect changes at end of study (week 52 for group randomized to Ustekinumab, week 64 for group randomized to Placebo) compared to baseline.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Patient-reported Physical Activity Assessments: IPAQ</title>
          <description>To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IPAQ, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).&#xD;
IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.</description>
          <units>MET-minutes/week</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.69" spread="808.45"/>
                    <measurement group_id="O2" value="853.28" spread="562.37"/>
                    <measurement group_id="O3" value="-779.59" spread="1049.99"/>
                  </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>0.4628</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-779.59</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1049.99</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2911.19</ci_lower_limit>
            <ci_upper_limit>1352.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2209</p_value>
            <method>Regression, Linear</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-910.84</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>729.96</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2395.95</ci_lower_limit>
            <ci_upper_limit>574.27</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>52 weeks for Ustekinumab arm, 64 weeks for Placebo arm.</time_frame>
      <desc>For each subject, AEs and SAEs occurring after informed consent is obtained should be recorded until the subject has completed his/her participation in the study.&#xD;
A serious adverse event must be reported if it occurs during a subject's participation in the Study (whether receiving Study Product or not) and within 12 weeks of receiving the last dose of Study Product in a clinical trial, whichever is longer.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ustekinumab (Stelara)</title>
          <description>Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter. From Baseline to Week 52.</description>
        </group>
        <group group_id="E2">
          <title>Placebo (RCT Period)</title>
          <description>Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator. From Baseline to Week 12 (RCT period only).</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Active Treatment Period)</title>
          <description>Placebo arm after crossing over to receive ustekinumab, following the same dosing schedule of the Ustekinumab arm. From Week 12 to Week 64 (52 weeks of active treatment period).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vasovagal reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>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="14" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>External ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Ear And Labyrinth Disorders/Ear Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hepatic Lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergies to foods, food additives, drugs and other chemicals</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Common cold</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="22"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Latent Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Trichomoniasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain/Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </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="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Anhedonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Panic Attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Uterine Fibroids Enlarged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blistering</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dermatitis Irritant Contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dysplastic Nevus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash/Rash Acneiform/Maculo-Papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Would Healing Delayed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Joel Gelfand</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>215-662-3514</phone>
      <email>joel.gelfand@pennmedicine.upenn.edu</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/NCT02187172
org study id: 820124
nct id: NCT02187172
lead sponsor: 
collaborator: 
has dmc: No
The VIP-U Study is a clinical trial designed to investigate the effect of ustekinumab
      (Stelara) and placebo on reducing vascular inflammation and cardiometabolic risk biomarkers
      in patients with moderate to severe psoriasis.

      This study will look for systemic vascular inflammation in study participants with a test
      called FDG PET/CT (fluorodeoxyglucose-positron emission tomography/computed tomography). The
      study will also look for cardiometabolic identifiers (heart disease and metabolic factors) in
      blood samples, including markers of high cholesterol, cholesterol efflux function (the
      ability of cholesterol to move in the body), metabolic factors, and inflammation.

      The study will also examine the effects of ustekinumab compared to placebo on psoriasis
      activity, severity and safety.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A hybrid RCT (randomized controlled trial) crossover trial where all patients receive total of 52 weeks of active treatment following an RCT phase of 12 weeks (active treatment or placebo). Patients randomized to active treatment will receive additional 40 weeks of active treatment at end of RCT phase; patients randomized to placebo will receive 52 weeks of active treatment at end of RCT phase. Primary outcomes are assessed at end of the RCT phase (comparison of interventions in change from start of treatment) and at end of 52 weeks of active treatment (change from start of treatment).
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Vascular Inflammation
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: Change in total vascular inflammation of five aortic segments as assessed on FDG-PET/CT between baseline and week 12 (RCT period) or end of study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period). The arterial uptake of FDG is measured by the standardized uptake value (SUV) max divided by the venous SUV mean yielding a target to background ratio (TBR).
measure: Change in Inflammatory Biomarker Levels: Intercellular Adhesion Molecule-1 (ICAM-1)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on ICAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: Vascular Cell Adhesion Molecule-1 (VCAM-1)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VCAM-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: C-reactive Protein (CRP)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on CRP, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: Ferritin
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Ferritin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: Serum Amyloid A (SAA)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on SAA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: Interferon-gamma (INF-g)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on INF-g,, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: Monocyte Chemoattractant Protein-1 (MCP-1)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MCP-1, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: Tumor Necrosis Factor-alpha (TNF-a)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on TNF-a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: GlycA
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on GlycA, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: Interleukin (IL)-1b
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-1b, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: IL-2ra
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-2ra, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: IL-12/23
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-12/23, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: IL-17a
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-17a, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: IL-18
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-18, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: IL-6
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-6, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Inflammatory Biomarker Levels: IL-8
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IL-8, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Triglycerides
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Total Cholesterol
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Total cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: High-density Lipoprotein (HDL) Cholesterol
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: HDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: HDL Particle Size
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Large-HDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Small-HDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Medium-HDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Large Medium-HDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-HDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Low-density Lipoprotein (LDL) Cholesterol
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL cholesterol, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: LDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: LDL Particle Size
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on LDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Small-LDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Large-LDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Very Large-LDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Very large-LDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Very Low-density Lipoprotein (VLDL) Particle Size
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle size, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: VLDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: VLDL Triglycerides
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on VLDL triglycerides, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Small-VLDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Small-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Medium-VLDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Large Medium-VLDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large medium-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Large-VLDL Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Large-VLDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Intermediate-density Lipoprotein (IDL) Particle Number
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IDL particle number, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Cholesterol Efflux Capacity
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Cholesterol efflux capacity, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
The ability to promote cholesterol efflux from macrophages is a classic function of HDL that is thought to be an important mechanism by which HDL protects against atherosclerosis. HDL cholesterol efflux capacity assays are performed based on published methods using J774 cells derived from a murine macrophage cell line (Mehta NN Atherosclerosis 2012). Efflux is calculated as a unitless measure by using the following formula: [(µCi of 3H-cholesterol in media containing apoB-depleted subject plasma - µCi of 3H-cholesterol in plasma-free media) / (µCi of 3H-cholesterol in media containing apoB-depleted pooled control plasma-µCi of 3H-cholesterol in pooled control plasma-free media)].
measure: Change in Lipid Biomarker Levels: Apolipoprotein-B
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Apolipoprotein-B, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Lipid Biomarker Levels: Fetuin-A
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Fetuin-A, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Metabolic Biomarker Levels: Adiponectin
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Adiponectin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Metabolic Biomarker Levels: Leptin
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Leptin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Metabolic Biomarker Levels: Insulin
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Insulin, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Metabolic Biomarker Levels: Glucose
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on Glucose, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
measure: Change in Metabolic Biomarker Levels: Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on HOMA-IR, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
HOMA-IR, a method used to quantify insulin resistance and beta-cell function, is expressed using fasting blood glucose and insulin levels. It is calculated using the formula (HOMA-IR = fasting glucose [mg/dl] * fasting insulin [mU/ml]/405).
measure: Number of Participants Achieving PASI75 (75% or Greater Reduction in PASI Score)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI75, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Binary measure of change in psoriasis activity; 75% or greater reduction in PASI score compared to baseline.
measure: Number of Participants Achieving PASI90 (90% or Greater Reduction in PASI Score)
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PASI90, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Binary measure of change in psoriasis activity; 90% or greater reduction in PASI score compared to baseline.
measure: Number of Participants Achieving Physician Global Assessment (PGA) Clear/Almost Clear
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on PGA clear/almost clear, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
Binary measure of psoriasis disease activity at measurement time points; Physician Global Assessment score <1.5 (clear/almost clear)
measure: Change in Patient-Reported Outcomes: MEDFICTS
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on MEDFICTS, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
MEDFICTS (Meats, Eggs, Dairy, Fried foods, fat In baked goods, Convenience foods, fats added at the Table, and Snacks), a brief dietary assessment instrument, has been provided as part of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) guidelines as a free tool to use for proper cardiovascular diet assessment. The questionnaire yields a continuous score (ranging from 0 to 216), with a score of <40 indicating adherence to the Therapeutic Lifestyle Changes (TLC) diet (intake of <7% of energy from saturated fat, <30% of energy from total fat, and <200 mg dietary cholesterol/day).
measure: Change in Patient-reported Physical Activity Assessments: IPAQ
time frame: Baseline - Week 12; Baseline - End of Study Visit (Week 52 or Week 64)
description: To assess the effects of ustekinumab, as compared to placebo, at Week 12 (RCT period) in patients with moderate to severe psoriasis on IPAQ, and assess global change at end study (Week 52 for Ustekinumab arm, Week 64 for Placebo arm; active treatment period).
IPAQ is an instrument designed primarily for population surveillance of physical activity among adults with activity measured in metabolic equivalent (MET)-minutes per week.
arm group label: Ustekinumab (Stelara)
arm group type: Active Comparator
description: Ustekinumab (Stelara) subcutaneous injection 45mg (if person's weight is 100kg or less) or 90mg (if person's weight is greater than 100kg) at day 0 and week 4 followed by every 12-week dosing thereafter. Patient will receive total of 52 weeks of ustekinumab (12 weeks during RCT phase, 40 weeks post RCT phase). The end of study is at Week 52 for this arm.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo subcutaneous injection will be given according to the same dose and schedule as the active comparator until week 12 (end of RCT phase). At week 12, ustekinumab will be administered according according to the same injection schedule as the active comparator arm for 52 weeks. Patient will receive total of 52 weeks of ustekinumab (0 weeks during RCT phase, 52 weeks post RCT phase). The end of study is at Week 64 for this arm.
intervention type: Drug
intervention name: Ustekinumab
arm group label: Placebo
arm group label: Ustekinumab (Stelara)
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joel M Gelfand, MD, MSCE
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Psoriasis
mesh term: Inflammation
mesh term: Ustekinumab
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 