<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/NCT03306589</url>
  </required_header>
  <id_info>
    <org_study_id>207654</org_study_id>
    <nct_id>NCT03306589</nct_id>
  </id_info>
  <brief_title>Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects</brief_title>
  <official_title>An Open Label Parallel Group Study to Investigate the Optimum Methodology for the Use of LPS or GM-CSF as Challenge Agents on Healthy Participants by Assessing Inflammatory Biomarkers in Cantharidin-induced Skin Blisters, Peripheral Blood, and Urine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This exploratory study aims to assess exposure of healthy subjects to systemic challenge with&#xD;
      either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular&#xD;
      activation markers both in circulation and in skin blisters induced by exposure to&#xD;
      cantharidin (an agent that causes blisters). LPS is often used to induce inflammation whereas&#xD;
      GM-CSF is a cytokine and a key mediator in inflammatory diseases. In this 2 parts study,&#xD;
      subjects will have 2 sessions in each part. Part I of the study is a dose-exploration phase&#xD;
      and part II will be a continuation phase to draw more precise outcomes. In session 1,&#xD;
      subjects will be randomized to receive either LPS or GM-CSF and will have 2 blisters induced&#xD;
      on each forearm followed by blood draws and a blister harvest on each forearm at 24 and 48&#xD;
      hours post-induction. After a minimum of 14 days blister healing period, subjects will return&#xD;
      for session 2. In part I, Up to 6 cohorts will be tested and all cohorts will have 2&#xD;
      sessions. For Part I, initially Cohort 1 will proceed with session 1. After their blister&#xD;
      healing period, Cohort 1 will return for their session 2 visit in two groups (Group A and&#xD;
      Group B) on different days. Group A will be dosed on the same day (one with LPS and one with&#xD;
      GM-CSF) and Group B will be dosed on a different day (one with LPS and one with GM-CSF) after&#xD;
      group A. Dose-escalation in Cohort 2-6 will be continued until the well tolerated dose has&#xD;
      been determined. The same dose will be administered to an additional Cohort in Part II and&#xD;
      the same 2-session design will be used. Approximately 24-30 healthy subjects will be enrolled&#xD;
      for the study and the total duration of the study for each subject will be approximately 13&#xD;
      weeks from screening to follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">June 20, 2018</completion_date>
  <primary_completion_date type="Actual">January 3, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Subjects in 2 separate groups will be randomized to receive either LPS or GM-CSF at the same time.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This will be an open label study and no masking will be performed.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm</measure>
    <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes,5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Each session was for three days. NA indicates that data was not available as standard deviation could not be calculated for a single participant. All participants who were randomized to receive the treatment (LPS or GM-CSF challenge) and received one dose of challenge agent were included in Safety Population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm</measure>
    <time_frame>Baseline, Session 2 Day 1</time_frame>
    <description>The post-challenge urine samples were collected during session 2 after LPS challenge. In session 2, participants were encouraged to pass urine immediately before LPS challenge dose and urine voids were collected from after LPS until 12 hours post-LPS and the time of the urine collection were recorded as post-challenge 1 to 11. These samples were collected for measurement of tetranor-PGDM. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. The data for normalized Tetranor PGDM was normalized by (Tetranor PGDM [pg/mL] divided by Creatinine [milligram per deciliter]) multiplied by 100. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm</measure>
    <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm</measure>
    <time_frame>Baseline, Session 2 Day 1</time_frame>
    <description>Urine samples were planned to be collected for analysis. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF</measure>
    <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated time-points for analysis of white blood cells. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF</measure>
    <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for analysis of white blood cells. Baseline value is Session 2 Day 1. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister</measure>
    <time_frame>Baseline; Session1: 48 hours on Day3; Session 2: 24 hours on Day 2 and 48 hours on Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta (b), Interferon-gamma (INFg), IL-6, IL-2, IL-8, Monocyte chemotactic protein-1 (MCP-1) and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister</measure>
    <time_frame>Baseline; Session1: 48 hours Day3; Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta, INFg, IL-6, IL-2, IL-8, MCP-1 and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Absolute Values of Blister Volume</measure>
    <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for analysis of blister volumes. . Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Absolute Values of Blister Volume</measure>
    <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for analysis of blister volumes. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Cell Numbers in Blister</measure>
    <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change From Baseline in Cell Numbers in Blister</measure>
    <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister. Activation markers included Cluster of Differentiation (CD) 16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and Human Leukocyte Antigen - antigen D Related (HLA-DR). Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister</measure>
    <time_frame>Baseline; Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for macrophages in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister</measure>
    <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
    <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood</measure>
    <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like IL-1 beta, INFg, IL-2, IL-8, and MCP-1 in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2:Change From Baseline in Soluble Inflammatory Mediators in Blood</measure>
    <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm</measure>
    <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like TNF-alpha, IL-6 and GM-CSF in blood. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF for GM-CSF Arm</measure>
    <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP)</measure>
    <time_frame>Baseline; Session 2: Post challenge Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like CRP in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: CRP</measure>
    <time_frame>Baseline; Session 2: Post challenge Day 1; Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood</measure>
    <time_frame>Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood</measure>
    <time_frame>Baseline, Session 2: 40 minutes, 2 hour 40 minutes, 5 hour 40 minutes,9hours 40 minutes on Day 1; Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood</measure>
    <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood</measure>
    <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm</measure>
    <time_frame>Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were collected at indicated time-points for analysis of leukocyte. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm</measure>
    <time_frame>Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
    <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>Subjects receiving LPS: Part I and Part II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible subjects will be randomized to receive LPS in a dose-escalation manner ranging from 0.5 nanogram (ng)/kg to 4 ng/kg. Subjects will be hydrated prior to administration of LPS with normal saline at a rate of 250 mL/hour for 4 hours prior to dosing and 8 hours after dosing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects receiving GM-CSF: Part I and Part II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible subjects will be randomized to receive GM-CSF in a dose-escalation manner ranging from 5 to 15 microgram (µg)/kg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Cantharidin</intervention_name>
    <description>5 microliter (µL) of 0.2 percent Cantharidin solution (diluted in acetone) will be applied to all subjects on forearm by topical route.</description>
    <arm_group_label>Subjects receiving GM-CSF: Part I and Part II</arm_group_label>
    <arm_group_label>Subjects receiving LPS: Part I and Part II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Lipopolysaccharide</intervention_name>
    <description>0.5 to 4 ng/kg body weight of LPS formulated as suspension in normal saline will be administered to randomized subjects via intravenous (IV) route in dose-escalation manner.</description>
    <arm_group_label>Subjects receiving LPS: Part I and Part II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Granulocyte-Macrophage Colony-Stimulating Factor</intervention_name>
    <description>5 to 15 µg/kg of GM-CSF will be administered to randomized subjects via subcutaneous (SC) route in the abdominal region in dose-escalation manner.</description>
    <arm_group_label>Subjects receiving GM-CSF: Part I and Part II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Solution</intervention_name>
    <description>0.9 percent sodium chloride will be administered via IV route to all subjects at a rate of 250 mL/hour for 4 hours prior to dosing with LPS and 8 hours after dosing with LPS.</description>
    <arm_group_label>Subjects receiving LPS: Part I and Part II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be 18 to 45 years of age inclusive, at the time of signing the informed&#xD;
             consent.&#xD;
&#xD;
          -  Subjects who are overtly healthy as determined by medical evaluation including:&#xD;
             medical history, physical examination, laboratory tests, and electrocardiogram (ECG).&#xD;
&#xD;
          -  Body mass index (BMI) within the range 19.0-30.0 kilogram per meter square (kg/m^2)&#xD;
             (inclusive).&#xD;
&#xD;
          -  All male subjects. All subjects must agree to use contraception during session 2 and&#xD;
             refrain from donating sperm from session 2 to end of study (follow up 2 visits).&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody&#xD;
             result within 3 months of screening.&#xD;
&#xD;
          -  A positive test for human immuno deficiency virus (HIV) antibody.&#xD;
&#xD;
          -  Persistent abnormal C-reactive protein/ white cell count (CRP/ WCC) levels at&#xD;
             screening.&#xD;
&#xD;
          -  Abnormal liver function tests at screening. For healthy subjects: Aspartate&#xD;
             aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and&#xD;
             bilirubin more than or equal to 1.5xupper limit of normal (ULN) (isolated bilirubin&#xD;
             more than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less&#xD;
             than 35 percent) at screening.&#xD;
&#xD;
          -  A positive pre-study drug/alcohol screen.&#xD;
&#xD;
          -  Current, or chronic history of (h/o): liver disease or known hepatic or biliary&#xD;
             abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones),&#xD;
             anaphylaxis, and /or anaphylactoid (resembling anaphylaxis) reactions; Cardiac,&#xD;
             respiratory or renal disease (childhood asthma can be included); Sensitivity or severe&#xD;
             allergic responses to any of the challenge agents or cantharidin, or components&#xD;
             thereof or a history of drug or other allergy that, in the opinion of the Investigator&#xD;
             or GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation;&#xD;
             Vasovagal syncope; Surgery or significant trauma in 3 months leading to study&#xD;
             enrolment; Relevant skin conditions (for example recent h/o eczema or recurrent&#xD;
             eczema, keloid, skin allergies, psoriasis, atopic dermatitis, and vitiligo) which in&#xD;
             the opinion of the investigator could pose safety issues or cause interference with&#xD;
             study procedures; Sepsis or known coagulation disorders; Peripheral edema,&#xD;
             lymphangitis, lymph edema, pleural or pericardial effusion; Respiratory conditions&#xD;
             including but not limited to asthma, Chronic obstructive pulmonary disease (COPD), and&#xD;
             bronchiectasis and any current respiratory infection.&#xD;
&#xD;
          -  Presence on either forearm of tattoos, naevi, hypertrophic scars, keloids, hyper or&#xD;
             hypo-pigmentation. Subjects with very fair skin, very dark skin, excessive hair or any&#xD;
             skin abnormalities that may, in the opinion of the Investigator, interfere with study&#xD;
             assessments.&#xD;
&#xD;
          -  Unable to refrain from the use of prescription drugs taken on an intermittent (as&#xD;
             needed) basis or non-prescription drugs; these include non-steroidal anti-inflammatory&#xD;
             drugs (NSAIDs), vitamins, herbal and dietary supplements (including St John's Wort)&#xD;
             within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives&#xD;
             (whichever is longer) prior to Day 1 of session 1 and continuing until the final&#xD;
             follow up visit).&#xD;
&#xD;
          -  The subject has participated in a clinical trial and has received an investigational&#xD;
             product within the following time period prior to the first dosing day in the current&#xD;
             study: 90 days, 5 half-lives or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer) or currently in a study of an&#xD;
             investigational device.&#xD;
&#xD;
          -  Previous exposure to LPS in a clinical research setting. Where participation in the&#xD;
             study would result in donation of blood or blood products in excess of 500 milliliter&#xD;
             (mL) within a 56-day period; Current smoker or former regular smoker within 6 months&#xD;
             before the screening visit; Unwillingness or inability to follow the procedures&#xD;
             outlined in the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 2GG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <results_first_submitted>June 17, 2019</results_first_submitted>
  <results_first_submitted_qc>June 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 8, 2019</results_first_posted>
  <last_update_submitted>June 17, 2019</last_update_submitted>
  <last_update_submitted_qc>June 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammation</keyword>
  <keyword>GM-CSF</keyword>
  <keyword>LPS</keyword>
  <keyword>Skin blisters</keyword>
  <keyword>Healthy subjects</keyword>
  <keyword>cantharidin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molgramostim</mesh_term>
    <mesh_term>Sargramostim</mesh_term>
    <mesh_term>Cantharidin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03306589/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03306589/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study aimed to assess 2 models of systemic inflammatory response: exposure of healthy participants to systemic challenge with either Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF).</recruitment_details>
      <pre_assignment_details>Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: LPS 0.5 ng/kg</title>
          <description>Participants were randomized to receive 0.5 nanogram/kilogram (ng/kg) LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: LPS 0.75 ng/kg</title>
          <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="P3">
          <title>Part 1: LPS 1 ng/kg</title>
          <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="P4">
          <title>Part 1: GM-CSF 60 µg/m^2</title>
          <description>Participants were randomized to receive 60 microgram per meter square (µg/m^2) GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
        </group>
        <group group_id="P5">
          <title>Part 2: Participants With LPS</title>
          <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
        </group>
        <group group_id="P6">
          <title>Part 2: Participants With GM-CSF</title>
          <description>Participants were planned to be dosed with GM-CSF (60 to a maximum of 480 µg/m^2) during Part 2 of the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1 (69 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 2 (69 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1: LPS 0.5 ng/kg</title>
          <description>Participants were randomized to receive 0.5 nanogram/kilogram (ng/kg) LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: LPS 0.75 ng/kg</title>
          <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="B3">
          <title>Part 1: LPS 1 ng/kg</title>
          <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="B4">
          <title>Part 1: GM-CSF 60 µg/m^2</title>
          <description>Participants were randomized to receive 60 microgram per meter square (µg/m^2) GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
        </group>
        <group group_id="B5">
          <title>Part 2: Participants With LPS</title>
          <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
        </group>
        <group group_id="B6">
          <title>Part 2: Participants With GM-CSF</title>
          <description>Participants were planned to be dosed with GM-CSF (60 to a maximum of 480 µg/m^2) during Part 2 of the study.</description>
        </group>
        <group group_id="B7">
          <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="2"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="2"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="0"/>
            <count group_id="B6" value="0"/>
            <count group_id="B7" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.5" spread="4.95"/>
                    <measurement group_id="B2" value="35.5" spread="7.55"/>
                    <measurement group_id="B3" value="31.5" spread="10.61"/>
                    <measurement group_id="B4" value="33.5" spread="7.33"/>
                    <measurement group_id="B7" value="32.2" spread="7.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B7" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Count of Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White: WHITE/CAUCASIAN/EUROPEAN HERITAGE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B7" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm</title>
        <description>Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Each session was for three days. NA indicates that data was not available as standard deviation could not be calculated for a single participant. All participants who were randomized to receive the treatment (LPS or GM-CSF challenge) and received one dose of challenge agent were included in Safety Population.</description>
        <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes,5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm</title>
          <description>Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Each session was for three days. NA indicates that data was not available as standard deviation could not be calculated for a single participant. All participants who were randomized to receive the treatment (LPS or GM-CSF challenge) and received one dose of challenge agent were included in Safety Population.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Picograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-6, Session2,Day1, -5 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4086" spread="0.09467"/>
                    <measurement group_id="O2" value="0.2798" spread="0.12546"/>
                    <measurement group_id="O3" value="-0.0126" spread="0.01785"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 10 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6460" spread="2.68681"/>
                    <measurement group_id="O2" value="0.2450" spread="0.16048"/>
                    <measurement group_id="O3" value="0.0123" spread="0.01746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 25 minutes, n=1, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3141" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="1.3623" spread="0.88290"/>
                    <measurement group_id="O3" value="1.8854" spread="0.15615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 40 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8074" spread="9.22779"/>
                    <measurement group_id="O2" value="8.7622" spread="8.41234"/>
                    <measurement group_id="O3" value="11.8672" spread="3.39867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 1 hour 10 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6395" spread="26.77767"/>
                    <measurement group_id="O2" value="81.0629" spread="104.23961"/>
                    <measurement group_id="O3" value="51.8232" spread="22.59507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 1 hour 40 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3221" spread="35.42047"/>
                    <measurement group_id="O2" value="193.7107" spread="218.97996"/>
                    <measurement group_id="O3" value="65.5675" spread="36.08430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 2 hour 40 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9321" spread="21.46574"/>
                    <measurement group_id="O2" value="133.2063" spread="92.47028"/>
                    <measurement group_id="O3" value="32.3842" spread="25.56374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 5 hour 40 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6991" spread="0.68051"/>
                    <measurement group_id="O2" value="2.5645" spread="1.20737"/>
                    <measurement group_id="O3" value="4.5141" spread="2.09962"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day2, Pre-fluid sampling, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8308" spread="16.52950"/>
                    <measurement group_id="O2" value="3.2880" spread="2.52703"/>
                    <measurement group_id="O3" value="0.3442" spread="0.03336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day3, Pre-fluid sampling, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4610" spread="0.08488"/>
                    <measurement group_id="O2" value="0.5909" spread="0.96127"/>
                    <measurement group_id="O3" value="0.1542" spread="0.21529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, -5 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2541" spread="0.33782"/>
                    <measurement group_id="O2" value="-0.0726" spread="0.14769"/>
                    <measurement group_id="O3" value="6.4056" spread="8.96887"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, 10 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5720" spread="1.84896"/>
                    <measurement group_id="O2" value="2.3784" spread="2.45156"/>
                    <measurement group_id="O3" value="12.7647" spread="13.08048"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, 25 minutes, n=1, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2469" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="56.6529" spread="51.91815"/>
                    <measurement group_id="O3" value="84.6080" spread="33.94449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, 40 minutes, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.1665" spread="37.61641"/>
                    <measurement group_id="O2" value="157.5403" spread="165.48643"/>
                    <measurement group_id="O3" value="152.9415" spread="60.31144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, 1hour 10minutes, n=2,4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.4949" spread="30.81434"/>
                    <measurement group_id="O2" value="202.6136" spread="215.34410"/>
                    <measurement group_id="O3" value="115.6693" spread="54.14279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, 1hour 40minutes, n=2,4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.3031" spread="20.26768"/>
                    <measurement group_id="O2" value="147.3472" spread="122.68010"/>
                    <measurement group_id="O3" value="78.4734" spread="38.13965"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, 2hour 40minutes, n=2,4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5571" spread="11.11988"/>
                    <measurement group_id="O2" value="68.8879" spread="24.42514"/>
                    <measurement group_id="O3" value="44.3372" spread="22.32753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day1, 5hour 40minutes, n=2,4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0087" spread="2.65663"/>
                    <measurement group_id="O2" value="15.4828" spread="7.05404"/>
                    <measurement group_id="O3" value="11.1378" spread="4.74317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day2,Pre-fluid sample, n=2,4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9279" spread="16.96994"/>
                    <measurement group_id="O2" value="1.2532" spread="0.83802"/>
                    <measurement group_id="O3" value="0.6475" spread="0.28268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha, Session2,Day3,Pre-fluid sample, n=2,4,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2453" spread="0.29126"/>
                    <measurement group_id="O2" value="0.2951" spread="0.39912"/>
                    <measurement group_id="O3" value="0.1391" spread="0.15747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm</title>
        <description>The post-challenge urine samples were collected during session 2 after LPS challenge. In session 2, participants were encouraged to pass urine immediately before LPS challenge dose and urine voids were collected from after LPS until 12 hours post-LPS and the time of the urine collection were recorded as post-challenge 1 to 11. These samples were collected for measurement of tetranor-PGDM. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. The data for normalized Tetranor PGDM was normalized by (Tetranor PGDM [pg/mL] divided by Creatinine [milligram per deciliter]) multiplied by 100. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline, Session 2 Day 1</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm</title>
          <description>The post-challenge urine samples were collected during session 2 after LPS challenge. In session 2, participants were encouraged to pass urine immediately before LPS challenge dose and urine voids were collected from after LPS until 12 hours post-LPS and the time of the urine collection were recorded as post-challenge 1 to 11. These samples were collected for measurement of tetranor-PGDM. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. The data for normalized Tetranor PGDM was normalized by (Tetranor PGDM [pg/mL] divided by Creatinine [milligram per deciliter]) multiplied by 100. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Picograms per milligram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session2, Day1,Post challenge1, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.846" spread="116.0073"/>
                    <measurement group_id="O2" value="-85.080" spread="226.4168"/>
                    <measurement group_id="O3" value="134.806" spread="166.6716"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 2, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.438" spread="112.5337"/>
                    <measurement group_id="O2" value="88.984" spread="155.1855"/>
                    <measurement group_id="O3" value="276.788" spread="134.7190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 3, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.006" spread="88.2367"/>
                    <measurement group_id="O2" value="25.390" spread="181.8009"/>
                    <measurement group_id="O3" value="200.337" spread="183.9484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 4, n=2, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-119.091" spread="304.0503"/>
                    <measurement group_id="O2" value="-68.209" spread="262.6169"/>
                    <measurement group_id="O3" value="140.482" spread="108.7880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 5, n=1, 4, 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112.355" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="-146.294" spread="165.8587"/>
                    <measurement group_id="O3" value="184.263" spread="262.9020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 6, n=0, 4, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-202.918" spread="197.6455"/>
                    <measurement group_id="O3" value="-125.839" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 7, n=0, 4, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-227.544" spread="226.2006"/>
                    <measurement group_id="O3" value="6.336" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 8, n=0, 3, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-144.855" spread="53.7768"/>
                    <measurement group_id="O3" value="-117.672" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 9, n=0, 2, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-147.066" spread="39.8858"/>
                    <measurement group_id="O3" value="-30.861" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 10, n=0, 1, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-172.982" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O3" value="-37.732" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day1,Post challenge 11, n=0, 1, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-199.316" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O3" value="-78.792" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm</title>
        <description>Blood samples were planned to be collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm</title>
          <description>Blood samples were planned to be collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm</title>
        <description>Urine samples were planned to be collected for analysis. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 2 Day 1</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm</title>
          <description>Urine samples were planned to be collected for analysis. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF</title>
        <description>Blood samples were collected at indicated time-points for analysis of white blood cells. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
        <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF</title>
          <description>Blood samples were collected at indicated time-points for analysis of white blood cells. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
          <population>Safety Population.</population>
          <units>Giga cells per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session2, Day 1, 40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3754" spread="2.78811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 1, 2 hours 40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7609" spread="2.94642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 1, 5 hours 40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8083" spread="1.11242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 1, 9 hours 40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4558" spread="0.82059"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 2, Pre-fluid sample</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4224" spread="1.01622"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 3, Pre-fluid sample</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0136" spread="2.05134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister</title>
        <description>Blister samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta (b), Interferon-gamma (INFg), IL-6, IL-2, IL-8, Monocyte chemotactic protein-1 (MCP-1) and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline; Session1: 48 hours on Day3; Session 2: 24 hours on Day 2 and 48 hours on Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister</title>
          <description>Blister samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta (b), Interferon-gamma (INFg), IL-6, IL-2, IL-8, Monocyte chemotactic protein-1 (MCP-1) and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Picograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IL-1b, Session1, Day 3, 48 hours, n=2, 2, 2,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.9691" spread="3.58338"/>
                    <measurement group_id="O2" value="-41.5298" spread="149.67553"/>
                    <measurement group_id="O3" value="3.6243" spread="35.28147"/>
                    <measurement group_id="O4" value="35.4452" spread="48.42938"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day2, 24 hours, n=2, 2, 2,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-48.4241" spread="69.70779"/>
                    <measurement group_id="O2" value="-83.1670" spread="108.13325"/>
                    <measurement group_id="O3" value="7.9733" spread="19.49142"/>
                    <measurement group_id="O4" value="-0.3579" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day3, 48 hours, n=2, 2, 2,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.0992" spread="46.78156"/>
                    <measurement group_id="O2" value="-81.6788" spread="130.42664"/>
                    <measurement group_id="O3" value="7.6783" spread="0.42508"/>
                    <measurement group_id="O4" value="-6.8302" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IFNg, Session1,Day3, 48 hours, n=2, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5244" spread="28.81866"/>
                    <measurement group_id="O3" value="55.9575" spread="65.86745"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IFNg, Session2,Day2, 24 hours, n=2, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8191" spread="6.06240"/>
                    <measurement group_id="O3" value="-4.5772" spread="7.20432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IFNg, Session2,Day3, 48 hours, n=2, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6652" spread="2.58511"/>
                    <measurement group_id="O3" value="2.9556" spread="13.15578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session1,Day3, 48 hours, n=2, 2, 2, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3470" spread="1.58747"/>
                    <measurement group_id="O2" value="-0.5699" spread="0.80595"/>
                    <measurement group_id="O3" value="0.1623" spread="0.22960"/>
                    <measurement group_id="O4" value="1.2444" spread="1.98677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day2, 24 hours, n=2, 2, 2, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2525" spread="0.66014"/>
                    <measurement group_id="O2" value="0.1804" spread="0.58673"/>
                    <measurement group_id="O3" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O4" value="0.0000" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day3, 48 hours, n=2, 2, 2, 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2451" spread="0.64975"/>
                    <measurement group_id="O2" value="2.1377" spread="2.64598"/>
                    <measurement group_id="O3" value="0.6968" spread="0.98543"/>
                    <measurement group_id="O4" value="2.1293" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session1,Day3,48 hours, n=2, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1588.01" spread="1379.357"/>
                    <measurement group_id="O3" value="1535.45" spread="3195.182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day2, 24 hours, n=1, 0, 1, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O3" value="-349.63" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day3, 48 hours, n=1, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.39" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O3" value="-25.74" spread="864.740"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session1,Day3,48 hours, n=2, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-127550.93" spread="141294.871"/>
                    <measurement group_id="O3" value="-42387.41" spread="31786.992"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day2, 24 hours, n=2, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31850.03" spread="186366.091"/>
                    <measurement group_id="O3" value="34295.91" spread="34575.984"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day3, 48 hours, n=2, 0, 2, 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-126387.78" spread="140485.270"/>
                    <measurement group_id="O3" value="-42836.70" spread="30559.892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session1,Day3, 48 hours, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36463.42" spread="4187.967"/>
                    <measurement group_id="O2" value="-10520.93" spread="5858.889"/>
                    <measurement group_id="O3" value="-18336.31" spread="9925.681"/>
                    <measurement group_id="O4" value="-10284.38" spread="10327.369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day2, 24 hours, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2842.63" spread="19696.319"/>
                    <measurement group_id="O2" value="4723.83" spread="11253.334"/>
                    <measurement group_id="O3" value="18049.87" spread="1010.158"/>
                    <measurement group_id="O4" value="4299.94" spread="11160.896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day3, 48 hours, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18920.55" spread="2850.508"/>
                    <measurement group_id="O2" value="1077.95" spread="10014.723"/>
                    <measurement group_id="O3" value="-16980.85" spread="11928.656"/>
                    <measurement group_id="O4" value="-11416.80" spread="9587.163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha,Session1,Day3,48 hours, n=2,2,2,3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-69.1140" spread="31.11083"/>
                    <measurement group_id="O2" value="-98.8930" spread="55.29269"/>
                    <measurement group_id="O3" value="-16.0826" spread="17.76133"/>
                    <measurement group_id="O4" value="-33.5839" spread="62.80430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha,Session2,Day2, 24 hours, n=2,2,2,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.3949" spread="68.42872"/>
                    <measurement group_id="O2" value="53.6996" spread="266.29344"/>
                    <measurement group_id="O3" value="34.8290" spread="63.07748"/>
                    <measurement group_id="O4" value="-29.6573" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF alpha,Session2,Day3,48 hours, n=2,2,2,1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-83.6471" spread="72.97148"/>
                    <measurement group_id="O2" value="-110.6500" spread="52.29742"/>
                    <measurement group_id="O3" value="-10.5091" spread="18.47463"/>
                    <measurement group_id="O4" value="-51.9244" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister</title>
        <description>Blister samples were planned to be collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta, INFg, IL-6, IL-2, IL-8, MCP-1 and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline; Session1: 48 hours Day3; Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister</title>
          <description>Blister samples were planned to be collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta, INFg, IL-6, IL-2, IL-8, MCP-1 and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Absolute Values of Blister Volume</title>
        <description>Blister samples were collected at indicated time-points for analysis of blister volumes. . Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline.</description>
        <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Absolute Values of Blister Volume</title>
          <description>Blister samples were collected at indicated time-points for analysis of blister volumes. . Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline.</description>
          <population>Safety Population.</population>
          <units>Microliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="361.325" spread="145.9115"/>
                    <measurement group_id="O2" value="156.638" spread="112.1876"/>
                    <measurement group_id="O3" value="185.550" spread="22.4860"/>
                    <measurement group_id="O4" value="230.425" spread="146.2442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session 1, Day 3, 48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="372.125" spread="105.8892"/>
                    <measurement group_id="O2" value="188.625" spread="128.1457"/>
                    <measurement group_id="O3" value="232.175" spread="15.0967"/>
                    <measurement group_id="O4" value="216.775" spread="141.8914"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session 2, Day 2, 24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156.225" spread="49.4621"/>
                    <measurement group_id="O2" value="102.838" spread="64.6195"/>
                    <measurement group_id="O3" value="162.975" spread="26.9054"/>
                    <measurement group_id="O4" value="105.363" spread="60.7083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session 2, Day 3, 48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="274.625" spread="110.4147"/>
                    <measurement group_id="O2" value="164.100" spread="104.8817"/>
                    <measurement group_id="O3" value="190.650" spread="10.6066"/>
                    <measurement group_id="O4" value="108.313" spread="79.5137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Absolute Values of Blister Volume</title>
        <description>Blister samples were planned to be collected at indicated time-points for analysis of blister volumes. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Absolute Values of Blister Volume</title>
          <description>Blister samples were planned to be collected at indicated time-points for analysis of blister volumes. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Cell Numbers in Blister</title>
        <description>Blister samples were collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
        <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Cell Numbers in Blister</title>
          <description>Blister samples were collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Cells per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session 1, Day 3, 48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="841250.0" spread="171473.39"/>
                    <measurement group_id="O2" value="-1405000.0" spread="6808193.03"/>
                    <measurement group_id="O3" value="667500.0" spread="1375322.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session 2, Day 2, 24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-298750.0" spread="2137230.25"/>
                    <measurement group_id="O2" value="-936062.5" spread="3258497.75"/>
                    <measurement group_id="O3" value="5447500.0" spread="7124100.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session 2, Day 3, 48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="586250.0" spread="786656.29"/>
                    <measurement group_id="O2" value="-1316000.0" spread="6556133.25"/>
                    <measurement group_id="O3" value="3275000.0" spread="1216223.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Change From Baseline in Cell Numbers in Blister</title>
        <description>Blood samples were planned to be collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in Cell Numbers in Blister</title>
          <description>Blood samples were planned to be collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister</title>
        <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister. Activation markers included Cluster of Differentiation (CD) 16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and Human Leukocyte Antigen - antigen D Related (HLA-DR). Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister</title>
          <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister. Activation markers included Cluster of Differentiation (CD) 16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and Human Leukocyte Antigen - antigen D Related (HLA-DR). Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Mean fluorescence intensity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD16+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
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                    <measurement group_id="O2" value="304.409" spread="387.9039"/>
                    <measurement group_id="O3" value="314.000" spread="129.4005"/>
                    <measurement group_id="O4" value="94.943" spread="140.1057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
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                    <measurement group_id="O2" value="507.721" spread="375.7470"/>
                    <measurement group_id="O3" value="711.250" spread="942.9269"/>
                    <measurement group_id="O4" value="174.016" spread="226.3189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
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                    <measurement group_id="O2" value="-26.379" spread="183.4741"/>
                    <measurement group_id="O3" value="438.250" spread="329.1582"/>
                    <measurement group_id="O4" value="279.814" spread="332.5659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1022.000" spread="291.3280"/>
                    <measurement group_id="O2" value="710.660" spread="645.7405"/>
                    <measurement group_id="O3" value="663.750" spread="149.5531"/>
                    <measurement group_id="O4" value="367.626" spread="245.5936"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.750" spread="217.4353"/>
                    <measurement group_id="O2" value="247.858" spread="249.5824"/>
                    <measurement group_id="O3" value="460.500" spread="120.2082"/>
                    <measurement group_id="O4" value="122.859" spread="88.9027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1173.750" spread="213.1927"/>
                    <measurement group_id="O2" value="585.093" spread="238.4787"/>
                    <measurement group_id="O3" value="978.750" spread="426.7389"/>
                    <measurement group_id="O4" value="713.995" spread="519.2420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session1,Day3, 48 hours, n=2, 2, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="849.00" spread="3251.277"/>
                    <measurement group_id="O2" value="-562.71" spread="207.541"/>
                    <measurement group_id="O3" value="3188.75" spread="5879.946"/>
                    <measurement group_id="O4" value="1295.95" spread="1671.924"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day2, 24 hours, n=2, 0, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.50" spread="2805.093"/>
                    <measurement group_id="O3" value="-1224.50" spread="1317.340"/>
                    <measurement group_id="O4" value="9194.06" spread="4046.382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day3, 48 hours, n=2, 0, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1596.50" spread="823.779"/>
                    <measurement group_id="O3" value="-1812.25" spread="1074.449"/>
                    <measurement group_id="O4" value="613.37" spread="1127.116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session1,Day3,48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="827.000" spread="478.7113"/>
                    <measurement group_id="O2" value="1256.721" spread="676.3278"/>
                    <measurement group_id="O3" value="377.500" spread="457.4981"/>
                    <measurement group_id="O4" value="753.682" spread="482.3904"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.750" spread="78.8424"/>
                    <measurement group_id="O2" value="63.622" spread="309.3805"/>
                    <measurement group_id="O3" value="982.250" spread="601.3943"/>
                    <measurement group_id="O4" value="1386.776" spread="1523.3802"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="577.750" spread="334.8151"/>
                    <measurement group_id="O2" value="767.291" spread="469.9624"/>
                    <measurement group_id="O3" value="1330.250" spread="491.7928"/>
                    <measurement group_id="O4" value="2161.950" spread="1465.6418"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.750" spread="47.7297"/>
                    <measurement group_id="O2" value="131.238" spread="104.7629"/>
                    <measurement group_id="O3" value="7.500" spread="108.8944"/>
                    <measurement group_id="O4" value="76.408" spread="149.4601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200.750" spread="211.7785"/>
                    <measurement group_id="O2" value="-60.255" spread="174.9309"/>
                    <measurement group_id="O3" value="116.500" spread="64.3467"/>
                    <measurement group_id="O4" value="436.294" spread="350.2183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day3, 48 hours, n=1, 4, 2, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-167.500" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant</measurement>
                    <measurement group_id="O2" value="-6.274" spread="238.7732"/>
                    <measurement group_id="O3" value="-8.250" spread="42.0729"/>
                    <measurement group_id="O4" value="236.171" spread="304.2282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="490.500" spread="236.1737"/>
                    <measurement group_id="O2" value="342.798" spread="181.3639"/>
                    <measurement group_id="O3" value="404.500" spread="137.8858"/>
                    <measurement group_id="O4" value="316.762" spread="145.7658"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.250" spread="284.6105"/>
                    <measurement group_id="O2" value="50.962" spread="31.2323"/>
                    <measurement group_id="O3" value="44.250" spread="158.0384"/>
                    <measurement group_id="O4" value="44.488" spread="94.3934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="286.250" spread="14.4957"/>
                    <measurement group_id="O2" value="324.662" spread="223.8334"/>
                    <measurement group_id="O3" value="254.000" spread="77.7817"/>
                    <measurement group_id="O4" value="401.521" spread="43.5362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-832.500" spread="89.8026"/>
                    <measurement group_id="O2" value="-816.619" spread="242.1554"/>
                    <measurement group_id="O3" value="-373.250" spread="578.7669"/>
                    <measurement group_id="O4" value="-824.574" spread="521.9010"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.250" spread="361.6851"/>
                    <measurement group_id="O2" value="44.949" spread="222.8885"/>
                    <measurement group_id="O3" value="791.500" spread="1207.0313"/>
                    <measurement group_id="O4" value="280.947" spread="870.1350"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-978.250" spread="339.0577"/>
                    <measurement group_id="O2" value="-773.455" spread="383.3063"/>
                    <measurement group_id="O3" value="-328.250" spread="171.4734"/>
                    <measurement group_id="O4" value="-529.900" spread="854.9675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-439.750" spread="195.5150"/>
                    <measurement group_id="O2" value="-51.662" spread="369.1392"/>
                    <measurement group_id="O3" value="-319.750" spread="71.7713"/>
                    <measurement group_id="O4" value="-497.468" spread="327.7072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-275.500" spread="30.4056"/>
                    <measurement group_id="O2" value="-241.591" spread="286.2295"/>
                    <measurement group_id="O3" value="103.750" spread="15.9099"/>
                    <measurement group_id="O4" value="6.398" spread="418.6691"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-723.250" spread="104.2983"/>
                    <measurement group_id="O2" value="312.288" spread="458.1399"/>
                    <measurement group_id="O3" value="-292.250" spread="16.6170"/>
                    <measurement group_id="O4" value="-97.004" spread="1081.7203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5189.00" spread="2028.689"/>
                    <measurement group_id="O2" value="-3291.05" spread="4596.102"/>
                    <measurement group_id="O3" value="-7267.75" spread="11655.595"/>
                    <measurement group_id="O4" value="-2543.35" spread="3800.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="388.50" spread="3168.545"/>
                    <measurement group_id="O2" value="-9344.96" spread="2661.368"/>
                    <measurement group_id="O3" value="-2229.25" spread="4812.922"/>
                    <measurement group_id="O4" value="10097.91" spread="12898.982"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7846.25" spread="6101.978"/>
                    <measurement group_id="O2" value="-10329.79" spread="4408.080"/>
                    <measurement group_id="O3" value="-9340.00" spread="10061.422"/>
                    <measurement group_id="O4" value="8884.70" spread="15377.757"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister</title>
        <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister</title>
          <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister</title>
        <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister</title>
          <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1475" spread="0.22981"/>
                    <measurement group_id="O2" value="0.2764" spread="0.19587"/>
                    <measurement group_id="O3" value="0.0610" spread="0.13294"/>
                    <measurement group_id="O4" value="-0.4060" spread="0.82999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0925" spread="0.15203"/>
                    <measurement group_id="O2" value="0.5062" spread="0.70807"/>
                    <measurement group_id="O3" value="0.5108" spread="0.67069"/>
                    <measurement group_id="O4" value="-0.0994" spread="1.34749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day3, 48 hours, n=1, 4, 2, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1210" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="0.3015" spread="0.39252"/>
                    <measurement group_id="O3" value="0.1300" spread="0.03748"/>
                    <measurement group_id="O4" value="-0.2698" spread="1.09270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister</title>
        <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister</title>
          <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister</title>
        <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline; Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister</title>
          <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Mean fluorescence intensity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD16+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.250" spread="48.4368"/>
                    <measurement group_id="O2" value="668.512" spread="634.0204"/>
                    <measurement group_id="O3" value="44.500" spread="90.5097"/>
                    <measurement group_id="O4" value="83.647" spread="119.1684"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="284.750" spread="2.4749"/>
                    <measurement group_id="O2" value="235.293" spread="200.9269"/>
                    <measurement group_id="O3" value="62.750" spread="48.4368"/>
                    <measurement group_id="O4" value="225.589" spread="233.9677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154.000" spread="44.5477"/>
                    <measurement group_id="O2" value="208.225" spread="339.7035"/>
                    <measurement group_id="O3" value="186.250" spread="254.9120"/>
                    <measurement group_id="O4" value="268.838" spread="315.3551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-103.7500" spread="129.04699"/>
                    <measurement group_id="O2" value="-91.1420" spread="123.34114"/>
                    <measurement group_id="O3" value="-105.7500" spread="107.83378"/>
                    <measurement group_id="O4" value="-16.6220" spread="31.79210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-112.7500" spread="143.89623"/>
                    <measurement group_id="O2" value="-49.4854" spread="72.90224"/>
                    <measurement group_id="O3" value="267.2500" spread="66.11448"/>
                    <measurement group_id="O4" value="47.1343" spread="60.71649"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-132.2500" spread="119.85460"/>
                    <measurement group_id="O2" value="-124.5144" spread="79.57686"/>
                    <measurement group_id="O3" value="-70.0000" spread="101.11627"/>
                    <measurement group_id="O4" value="-32.4464" spread="30.09999"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session1,Day3, 48 hours, n=2, 2, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-56.00" spread="601.041"/>
                    <measurement group_id="O2" value="-1057.04" spread="1641.526"/>
                    <measurement group_id="O3" value="1372.75" spread="2325.321"/>
                    <measurement group_id="O4" value="2032.27" spread="1708.909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day2, 24 hours, n=2, 0, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-430.25" spread="1407.496"/>
                    <measurement group_id="O3" value="-665.00" spread="481.540"/>
                    <measurement group_id="O4" value="3032.02" spread="3183.213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day3, 48 hours, n=2, 0, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="171.120"/>
                    <measurement group_id="O3" value="198.75" spread="150.260"/>
                    <measurement group_id="O4" value="856.32" spread="1654.671"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session1,Day3,48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.250" spread="15.2028"/>
                    <measurement group_id="O2" value="765.140" spread="690.4086"/>
                    <measurement group_id="O3" value="-211.000" spread="17.6777"/>
                    <measurement group_id="O4" value="95.101" spread="191.7562"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.750" spread="37.1231"/>
                    <measurement group_id="O2" value="38.604" spread="582.9139"/>
                    <measurement group_id="O3" value="743.750" spread="482.6004"/>
                    <measurement group_id="O4" value="1834.867" spread="1573.3002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.750" spread="341.1790"/>
                    <measurement group_id="O2" value="297.936" spread="605.5896"/>
                    <measurement group_id="O3" value="835.000" spread="444.7702"/>
                    <measurement group_id="O4" value="1822.510" spread="1522.9886"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="963.750" spread="110.6622"/>
                    <measurement group_id="O2" value="1403.000" spread="754.2476"/>
                    <measurement group_id="O3" value="776.000" spread="30.4056"/>
                    <measurement group_id="O4" value="923.024" spread="560.8252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.000" spread="266.5793"/>
                    <measurement group_id="O2" value="17.354" spread="257.3845"/>
                    <measurement group_id="O3" value="-10.250" spread="61.1647"/>
                    <measurement group_id="O4" value="293.485" spread="249.0144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day3, 48 hours, n=1, 4, 2, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="383.500" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="1072.416" spread="523.9965"/>
                    <measurement group_id="O3" value="783.750" spread="127.6328"/>
                    <measurement group_id="O4" value="1389.536" spread="710.1286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2609.000" spread="376.8879"/>
                    <measurement group_id="O2" value="4155.674" spread="893.4273"/>
                    <measurement group_id="O3" value="2366.000" spread="72.8320"/>
                    <measurement group_id="O4" value="4998.865" spread="1326.4663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-130.000" spread="523.2590"/>
                    <measurement group_id="O2" value="-583.016" spread="1305.3774"/>
                    <measurement group_id="O3" value="-237.250" spread="252.0836"/>
                    <measurement group_id="O4" value="407.277" spread="615.0693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1235.000" spread="603.8692"/>
                    <measurement group_id="O2" value="3665.666" spread="1565.6126"/>
                    <measurement group_id="O3" value="1407.250" spread="331.9866"/>
                    <measurement group_id="O4" value="3958.838" spread="803.7564"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2342.250" spread="423.2034"/>
                    <measurement group_id="O2" value="2806.835" spread="741.9070"/>
                    <measurement group_id="O3" value="2624.000" spread="770.7464"/>
                    <measurement group_id="O4" value="3834.100" spread="1511.6374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.000" spread="656.9022"/>
                    <measurement group_id="O2" value="-409.187" spread="1498.2826"/>
                    <measurement group_id="O3" value="-343.250" spread="597.1517"/>
                    <measurement group_id="O4" value="648.346" spread="685.4282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1199.500" spread="900.8540"/>
                    <measurement group_id="O2" value="3368.105" spread="953.2468"/>
                    <measurement group_id="O3" value="2924.250" spread="510.1775"/>
                    <measurement group_id="O4" value="3264.300" spread="988.2407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2590.75" spread="1485.278"/>
                    <measurement group_id="O2" value="4689.54" spread="1189.323"/>
                    <measurement group_id="O3" value="2701.50" spread="65.761"/>
                    <measurement group_id="O4" value="3936.29" spread="2537.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-509.75" spread="345.422"/>
                    <measurement group_id="O2" value="-696.70" spread="1551.690"/>
                    <measurement group_id="O3" value="-184.00" spread="373.352"/>
                    <measurement group_id="O4" value="94.29" spread="782.682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1175.25" spread="980.404"/>
                    <measurement group_id="O2" value="7229.67" spread="2733.004"/>
                    <measurement group_id="O3" value="2750.50" spread="421.436"/>
                    <measurement group_id="O4" value="4132.68" spread="2423.146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1020.00" spread="2766.909"/>
                    <measurement group_id="O2" value="31657.05" spread="11524.385"/>
                    <measurement group_id="O3" value="-2661.75" spread="19339.017"/>
                    <measurement group_id="O4" value="3242.86" spread="11323.629"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-494.00" spread="1211.981"/>
                    <measurement group_id="O2" value="-3470.23" spread="16869.569"/>
                    <measurement group_id="O3" value="480.50" spread="11477.050"/>
                    <measurement group_id="O4" value="11902.82" spread="17969.677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4386.50" spread="911.461"/>
                    <measurement group_id="O2" value="16282.97" spread="22938.047"/>
                    <measurement group_id="O3" value="1564.00" spread="12854.494"/>
                    <measurement group_id="O4" value="19351.27" spread="16136.948"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister</title>
        <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister</title>
          <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister</title>
        <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister</title>
          <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7675" spread="5.32805"/>
                    <measurement group_id="O2" value="43.2094" spread="6.81783"/>
                    <measurement group_id="O3" value="47.8100" spread="4.17193"/>
                    <measurement group_id="O4" value="39.8453" spread="6.60325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7250" spread="14.65125"/>
                    <measurement group_id="O2" value="0.0825" spread="18.06488"/>
                    <measurement group_id="O3" value="0.0900" spread="1.52735"/>
                    <measurement group_id="O4" value="6.7523" spread="9.76233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day3, 48 hours, n=1, 4, 2, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7000" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="42.6493" spread="11.60035"/>
                    <measurement group_id="O3" value="42.5100" spread="2.82843"/>
                    <measurement group_id="O4" value="38.4313" spread="6.81975"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister</title>
        <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister</title>
          <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister</title>
        <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for macrophages in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister</title>
          <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for macrophages in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Mean fluorescence intensity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD16+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5027.00" spread="5289.866"/>
                    <measurement group_id="O2" value="4510.75" spread="7162.125"/>
                    <measurement group_id="O3" value="-3449.75" spread="1895.400"/>
                    <measurement group_id="O4" value="-2607.25" spread="6559.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13111.25" spread="32672.929"/>
                    <measurement group_id="O2" value="-2948.25" spread="3659.787"/>
                    <measurement group_id="O3" value="5372.75" spread="235.113"/>
                    <measurement group_id="O4" value="-1010.00" spread="5492.201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4621.75" spread="8382.397"/>
                    <measurement group_id="O2" value="-6203.50" spread="13105.657"/>
                    <measurement group_id="O3" value="-3286.25" spread="947.170"/>
                    <measurement group_id="O4" value="-3653.63" spread="5345.655"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="888.500" spread="292.0351"/>
                    <measurement group_id="O2" value="400.500" spread="455.9359"/>
                    <measurement group_id="O3" value="270.250" spread="97.9343"/>
                    <measurement group_id="O4" value="723.125" spread="717.7969"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.750" spread="215.3140"/>
                    <measurement group_id="O2" value="48.250" spread="163.7506"/>
                    <measurement group_id="O3" value="415.250" spread="142.4820"/>
                    <measurement group_id="O4" value="169.750" spread="160.7060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1012.000" spread="501.3387"/>
                    <measurement group_id="O2" value="411.000" spread="524.8443"/>
                    <measurement group_id="O3" value="719.250" spread="63.9932"/>
                    <measurement group_id="O4" value="789.513" spread="825.7539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.00" spread="2206.173"/>
                    <measurement group_id="O2" value="-1275.50" spread="3073.903"/>
                    <measurement group_id="O3" value="-955.75" spread="1183.343"/>
                    <measurement group_id="O4" value="-734.88" spread="5799.935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4503.00" spread="9540.992"/>
                    <measurement group_id="O2" value="564.00" spread="2911.625"/>
                    <measurement group_id="O3" value="-1329.50" spread="1668.065"/>
                    <measurement group_id="O4" value="12596.63" spread="16264.004"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1229.25" spread="973.332"/>
                    <measurement group_id="O2" value="-2542.63" spread="4084.922"/>
                    <measurement group_id="O3" value="-2193.50" spread="543.765"/>
                    <measurement group_id="O4" value="-2622.75" spread="3423.992"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session1,Day3,48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="931.00" spread="505.581"/>
                    <measurement group_id="O2" value="458.88" spread="1827.032"/>
                    <measurement group_id="O3" value="-333.00" spread="416.486"/>
                    <measurement group_id="O4" value="890.88" spread="2206.644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="474.75" spread="485.429"/>
                    <measurement group_id="O2" value="21.63" spread="1282.820"/>
                    <measurement group_id="O3" value="1672.25" spread="1038.386"/>
                    <measurement group_id="O4" value="5641.13" spread="4969.374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="565.75" spread="840.396"/>
                    <measurement group_id="O2" value="-236.13" spread="1413.395"/>
                    <measurement group_id="O3" value="1607.75" spread="1283.752"/>
                    <measurement group_id="O4" value="2835.13" spread="2917.207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="593.25" spread="20.860"/>
                    <measurement group_id="O2" value="198.00" spread="1021.994"/>
                    <measurement group_id="O3" value="371.75" spread="1282.338"/>
                    <measurement group_id="O4" value="-59.50" spread="536.615"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1007.00" spread="1119.350"/>
                    <measurement group_id="O2" value="-43.38" spread="837.351"/>
                    <measurement group_id="O3" value="-691.50" spread="542.351"/>
                    <measurement group_id="O4" value="3426.13" spread="4547.393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day3, 48 hours, n=1, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.50" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="-166.13" spread="503.207"/>
                    <measurement group_id="O3" value="-480.25" spread="925.956"/>
                    <measurement group_id="O4" value="-70.50" spread="1739.426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="884.00" spread="9.899"/>
                    <measurement group_id="O2" value="1193.63" spread="1486.267"/>
                    <measurement group_id="O3" value="1403.75" spread="3760.040"/>
                    <measurement group_id="O4" value="304.88" spread="2126.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1250.50" spread="1339.967"/>
                    <measurement group_id="O2" value="353.63" spread="2446.460"/>
                    <measurement group_id="O3" value="-1136.25" spread="1490.935"/>
                    <measurement group_id="O4" value="1215.88" spread="2013.518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-84.75" spread="23.688"/>
                    <measurement group_id="O2" value="-114.50" spread="615.327"/>
                    <measurement group_id="O3" value="-1686.50" spread="2957.121"/>
                    <measurement group_id="O4" value="-744.88" spread="3479.863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1139.00" spread="477.297"/>
                    <measurement group_id="O2" value="-556.88" spread="1063.877"/>
                    <measurement group_id="O3" value="2522.00" spread="1359.766"/>
                    <measurement group_id="O4" value="-842.63" spread="1505.636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="420.50" spread="3235.014"/>
                    <measurement group_id="O2" value="1243.25" spread="3307.491"/>
                    <measurement group_id="O3" value="2690.50" spread="4319.008"/>
                    <measurement group_id="O4" value="918.75" spread="1945.597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1703.75" spread="15.203"/>
                    <measurement group_id="O2" value="-1046.38" spread="561.034"/>
                    <measurement group_id="O3" value="745.75" spread="496.743"/>
                    <measurement group_id="O4" value="-1668.63" spread="2068.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="792.50" spread="338.704"/>
                    <measurement group_id="O2" value="577.50" spread="1141.719"/>
                    <measurement group_id="O3" value="2311.50" spread="1262.186"/>
                    <measurement group_id="O4" value="28.25" spread="2057.408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="381.25" spread="2896.663"/>
                    <measurement group_id="O2" value="674.50" spread="1496.032"/>
                    <measurement group_id="O3" value="-329.75" spread="197.636"/>
                    <measurement group_id="O4" value="-570.75" spread="3118.314"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.75" spread="285.318"/>
                    <measurement group_id="O2" value="1692.50" spread="1687.192"/>
                    <measurement group_id="O3" value="181.75" spread="506.642"/>
                    <measurement group_id="O4" value="517.50" spread="5171.981"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3326.25" spread="1854.388"/>
                    <measurement group_id="O2" value="-7695.38" spread="19317.582"/>
                    <measurement group_id="O3" value="6003.75" spread="17276.386"/>
                    <measurement group_id="O4" value="-5724.25" spread="49407.676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7435.25" spread="35884.608"/>
                    <measurement group_id="O2" value="13061.88" spread="29527.416"/>
                    <measurement group_id="O3" value="1273.75" spread="3391.638"/>
                    <measurement group_id="O4" value="36041.13" spread="33139.756"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-882.00" spread="1575.434"/>
                    <measurement group_id="O2" value="-20377.25" spread="25175.815"/>
                    <measurement group_id="O3" value="-8397.75" spread="19009.505"/>
                    <measurement group_id="O4" value="11460.13" spread="56951.939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister</title>
        <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister</title>
          <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister</title>
        <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister</title>
          <description>Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session1,Day3, 48 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0475" spread="9.89596"/>
                    <measurement group_id="O2" value="-1.2837" spread="17.00275"/>
                    <measurement group_id="O3" value="21.8500" spread="26.44579"/>
                    <measurement group_id="O4" value="-0.8938" spread="20.18664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day2, 24 hours, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1225" spread="35.88213"/>
                    <measurement group_id="O2" value="1.3537" spread="22.85581"/>
                    <measurement group_id="O3" value="-16.0250" spread="3.35876"/>
                    <measurement group_id="O4" value="9.1137" spread="15.78332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day3, 48 hours, n=1, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3500" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="-2.9838" spread="10.58741"/>
                    <measurement group_id="O3" value="-8.9750" spread="17.00592"/>
                    <measurement group_id="O4" value="-3.2238" spread="27.65006"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister</title>
        <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister</title>
          <description>Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood</title>
        <description>Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like IL-1 beta, INFg, IL-2, IL-8, and MCP-1 in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
        <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood</title>
          <description>Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like IL-1 beta, INFg, IL-2, IL-8, and MCP-1 in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Picograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>INFg, Session2,Day1, -5 minutes, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5636" spread="0.24961"/>
                    <measurement group_id="O2" value="-0.1278" spread="0.23076"/>
                    <measurement group_id="O3" value="0.0653" spread="0.80201"/>
                    <measurement group_id="O4" value="5.7255" spread="1.85029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day1, 10 minutes, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4140" spread="0.05250"/>
                    <measurement group_id="O2" value="-0.3298" spread="0.20362"/>
                    <measurement group_id="O3" value="-0.2355" spread="0.28729"/>
                    <measurement group_id="O4" value="6.0071" spread="1.26842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day1, 25 minutes, n=1, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6996" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="-0.3697" spread="0.19518"/>
                    <measurement group_id="O3" value="-0.2432" spread="0.30593"/>
                    <measurement group_id="O4" value="6.1605" spread="1.77144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day1, 40 minutes, n=2, 4, 2, 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6745" spread="0.26829"/>
                    <measurement group_id="O2" value="-0.4771" spread="0.41990"/>
                    <measurement group_id="O3" value="0.1501" spread="0.28816"/>
                    <measurement group_id="O4" value="5.4142" spread="2.07138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day1, 1 hour 10 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8597" spread="2.47610"/>
                    <measurement group_id="O2" value="1.7673" spread="1.80932"/>
                    <measurement group_id="O3" value="6.6083" spread="0.78111"/>
                    <measurement group_id="O4" value="4.9508" spread="1.77082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day1, 1 hour 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5709" spread="5.72091"/>
                    <measurement group_id="O2" value="6.5863" spread="3.69982"/>
                    <measurement group_id="O3" value="13.6809" spread="3.56564"/>
                    <measurement group_id="O4" value="3.8804" spread="2.00819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day1, 2 hour 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1319" spread="7.94104"/>
                    <measurement group_id="O2" value="8.7498" spread="2.97730"/>
                    <measurement group_id="O3" value="15.7306" spread="3.51048"/>
                    <measurement group_id="O4" value="2.7181" spread="2.63053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day1, 5 hour 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5927" spread="3.83382"/>
                    <measurement group_id="O2" value="3.2672" spread="1.86587"/>
                    <measurement group_id="O3" value="5.0294" spread="3.92184"/>
                    <measurement group_id="O4" value="1.7041" spread="1.64895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day2, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7611" spread="1.04373"/>
                    <measurement group_id="O2" value="0.7630" spread="1.43167"/>
                    <measurement group_id="O3" value="-0.3514" spread="1.05828"/>
                    <measurement group_id="O4" value="-3.0755" spread="2.76516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INFg, Session2,Day3, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3628" spread="0.31014"/>
                    <measurement group_id="O2" value="1.5962" spread="3.09933"/>
                    <measurement group_id="O3" value="-2.6600" spread="1.75306"/>
                    <measurement group_id="O4" value="-3.2817" spread="2.72811"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, -5 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O2" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O3" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, 10 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O2" value="0.0008" spread="0.00150"/>
                    <measurement group_id="O3" value="0.0000" spread="0.0000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, 25 minutes, n=1, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, 40 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.0008" spread="0.00150"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, 1hour 10minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.0008" spread="0.00150"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, 1hour 40minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.1875" spread="0.37303"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, 2hour 40minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.3194" spread="0.41468"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day1, 5hour 40minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.0008" spread="0.00150"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day2,Pre-fluid sample, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2225" spread="0.31897"/>
                    <measurement group_id="O2" value="0.0008" spread="0.00150"/>
                    <measurement group_id="O3" value="-0.0030" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0857" spread="0.10517"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-1b, Session2,Day3,Pre-fluid sample, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0030" spread="0.00000"/>
                    <measurement group_id="O2" value="0.0008" spread="0.00150"/>
                    <measurement group_id="O3" value="-0.0030" spread="0.00000"/>
                    <measurement group_id="O4" value="-0.0015" spread="0.00173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, -5 minutes, n=0, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, 10 minutes, n=0, 4, 2,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, 25 minutes, n=0, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, 40 minutes, n=0, 3, 2,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, 1 hour 10 minutes, n=0, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, 1 hour 40 minutes, n=0, 4,2,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, 2 hour 40 minutes, n=0, 4,2,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day1, 5 hour 40 minutes, n=0, 4,2,2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O4" value="0.0000" spread="0.00000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day2, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="-0.0160" spread="0.00000"/>
                    <measurement group_id="O4" value="-0.0018" spread="0.01645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-2, Session2,Day3, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0000" spread="0.00000"/>
                    <measurement group_id="O2" value="0.0031" spread="0.00625"/>
                    <measurement group_id="O3" value="-0.0160" spread="0.00000"/>
                    <measurement group_id="O4" value="-0.0018" spread="0.01645"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, -5 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4835" spread="2.97824"/>
                    <measurement group_id="O2" value="0.0761" spread="0.99505"/>
                    <measurement group_id="O3" value="0.1849" spread="0.08020"/>
                    <measurement group_id="O4" value="83.1531" spread="44.11662"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, 10 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2890" spread="3.42770"/>
                    <measurement group_id="O2" value="0.0714" spread="1.30027"/>
                    <measurement group_id="O3" value="0.8613" spread="0.83194"/>
                    <measurement group_id="O4" value="89.0123" spread="48.41011"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, 25 minutes, n=1, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7998" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="0.6814" spread="1.27650"/>
                    <measurement group_id="O3" value="3.0142" spread="1.22739"/>
                    <measurement group_id="O4" value="86.4178" spread="47.57975"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, 40 minutes, n=2, 3, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4905" spread="1.93306"/>
                    <measurement group_id="O2" value="9.3036" spread="5.86829"/>
                    <measurement group_id="O3" value="27.1507" spread="3.96686"/>
                    <measurement group_id="O4" value="50.4514" spread="20.49601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, 1 hour 10 minutes, n=2, 3,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.0587" spread="43.02522"/>
                    <measurement group_id="O2" value="141.7558" spread="104.21164"/>
                    <measurement group_id="O3" value="162.3033" spread="42.93991"/>
                    <measurement group_id="O4" value="76.6709" spread="36.79748"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, 1 hour 40 minutes, n=2,3, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214.1372" spread="181.31639"/>
                    <measurement group_id="O2" value="468.8635" spread="296.06234"/>
                    <measurement group_id="O3" value="229.6116" spread="155.88116"/>
                    <measurement group_id="O4" value="77.3493" spread="73.83422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, 2 hour 40 minutes, n=2,3, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.6247" spread="26.76026"/>
                    <measurement group_id="O2" value="340.0657" spread="234.74182"/>
                    <measurement group_id="O3" value="111.6155" spread="118.63027"/>
                    <measurement group_id="O4" value="126.3552" spread="204.81735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day1, 5 hour 40 minutes, n=2,3, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6772" spread="3.55867"/>
                    <measurement group_id="O2" value="88.5574" spread="24.09240"/>
                    <measurement group_id="O3" value="19.5090" spread="6.86764"/>
                    <measurement group_id="O4" value="30.1483" spread="10.71198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day2, Pre-fluid sampling, n=2,3,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8330" spread="7.21699"/>
                    <measurement group_id="O2" value="8.7544" spread="16.57327"/>
                    <measurement group_id="O3" value="-1.3116" spread="1.93618"/>
                    <measurement group_id="O4" value="33.5296" spread="54.13468"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-8, Session2,Day3, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3819" spread="2.32148"/>
                    <measurement group_id="O2" value="0.6465" spread="2.78896"/>
                    <measurement group_id="O3" value="-0.8507" spread="0.69264"/>
                    <measurement group_id="O4" value="-2.0468" spread="1.21979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, -5 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.984" spread="0.9353"/>
                    <measurement group_id="O2" value="7.280" spread="11.0662"/>
                    <measurement group_id="O3" value="-12.078" spread="6.4316"/>
                    <measurement group_id="O4" value="2702.736" spread="1675.5428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, 10 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.716" spread="33.8987"/>
                    <measurement group_id="O2" value="15.335" spread="18.3588"/>
                    <measurement group_id="O3" value="-6.963" spread="11.3479"/>
                    <measurement group_id="O4" value="3692.647" spread="1671.9037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, 25 minutes, n=1, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.166" spread="NA">NA indicates that data was not available as standard deviation could not be calculated for a single participant.</measurement>
                    <measurement group_id="O2" value="22.679" spread="14.0540"/>
                    <measurement group_id="O3" value="9.360" spread="10.2709"/>
                    <measurement group_id="O4" value="4354.050" spread="1579.4757"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, 40 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.774" spread="44.7737"/>
                    <measurement group_id="O2" value="108.005" spread="54.2180"/>
                    <measurement group_id="O3" value="273.261" spread="29.0646"/>
                    <measurement group_id="O4" value="4218.511" spread="1850.5204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, 1 hour 10 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1092.558" spread="576.0879"/>
                    <measurement group_id="O2" value="3281.560" spread="2188.7631"/>
                    <measurement group_id="O3" value="2993.718" spread="17.3345"/>
                    <measurement group_id="O4" value="4119.865" spread="2047.7930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, 1 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2521.255" spread="1886.7927"/>
                    <measurement group_id="O2" value="5164.946" spread="25.3073"/>
                    <measurement group_id="O3" value="6182.663" spread="13.9688"/>
                    <measurement group_id="O4" value="2659.013" spread="1778.3867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1449.223" spread="880.4065"/>
                    <measurement group_id="O2" value="5189.946" spread="75.0973"/>
                    <measurement group_id="O3" value="6824.798" spread="3014.6330"/>
                    <measurement group_id="O4" value="1405.284" spread="603.0458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.224" spread="72.8644"/>
                    <measurement group_id="O2" value="588.424" spread="384.1274"/>
                    <measurement group_id="O3" value="350.071" spread="81.7289"/>
                    <measurement group_id="O4" value="365.641" spread="156.6637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day2,Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.963" spread="23.0612"/>
                    <measurement group_id="O2" value="38.016" spread="54.7584"/>
                    <measurement group_id="O3" value="-2.917" spread="42.8500"/>
                    <measurement group_id="O4" value="-14.427" spread="32.7430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCP-1, Session2,Day3,Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.333" spread="0.9485"/>
                    <measurement group_id="O2" value="28.822" spread="23.2955"/>
                    <measurement group_id="O3" value="8.210" spread="9.0286"/>
                    <measurement group_id="O4" value="-15.571" spread="25.0756"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2:Change From Baseline in Soluble Inflammatory Mediators in Blood</title>
        <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2:Change From Baseline in Soluble Inflammatory Mediators in Blood</title>
          <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm</title>
        <description>Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like TNF-alpha, IL-6 and GM-CSF in blood. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
        <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm</title>
          <description>Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like TNF-alpha, IL-6 and GM-CSF in blood. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
          <population>Safety Population.</population>
          <units>Picograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GM-CSF, Session2,Day1, -5 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1674.235" spread="635.9050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day1, 10 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1260.988" spread="850.1777"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day1, 25 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="624.895" spread="287.0075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day1, 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364.045" spread="218.4348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day1,1 hour 10 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.793" spread="97.7248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day1,1 hour 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.158" spread="39.5878"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day1,2 hour 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.486" spread="9.9232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day1,5 hour 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day2,Pre-fluid sampling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GM-CSF, Session2,Day3,Pre-fluid sampling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.0000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, -5 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8136" spread="3.54771"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 10 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3851" spread="1.98376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 25 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0699" spread="3.47569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9359" spread="5.03738"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 1hour 10minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8485" spread="3.17943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 1hour 40minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0334" spread="2.72854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 2hour 40minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6496" spread="1.56258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day1, 5hour 40minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9135" spread="1.60586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day2,Pre-fluid sample</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2598" spread="1.72396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL-6, Session2,Day3,Pre-fluid sample</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.0324" spread="0.13824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, -5 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6740" spread="0.39814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, 10 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4860" spread="0.70400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, 25 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5475" spread="0.86898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2100" spread="0.99729"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, 1 hour 10 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1380" spread="0.90651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, 1 hour 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9665" spread="1.19555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, 2 hour 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6001" spread="0.80929"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day1, 5 hour 40 minutes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9562" spread="0.63271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day2, Pre-fluid sampling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5423" spread="0.50847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha, Session2,Day3, Pre-fluid sampling</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1194" spread="0.55216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF for GM-CSF Arm</title>
        <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF for GM-CSF Arm</title>
          <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP)</title>
        <description>Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like CRP in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
        <time_frame>Baseline; Session 2: Post challenge Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP)</title>
          <description>Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like CRP in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
          <population>Safety Population.</population>
          <units>Milligrams per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session2,Day1, Post-challenge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="3.111"/>
                    <measurement group_id="O2" value="2.75" spread="0.624"/>
                    <measurement group_id="O3" value="2.40" spread="0.990"/>
                    <measurement group_id="O4" value="1.53" spread="0.457"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day 2, Pre-fluid sample</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.50" spread="4.667"/>
                    <measurement group_id="O2" value="21.80" spread="2.380"/>
                    <measurement group_id="O3" value="18.55" spread="4.455"/>
                    <measurement group_id="O4" value="5.80" spread="1.623"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2,Day 3, Pre-fluid sample</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" spread="3.111"/>
                    <measurement group_id="O2" value="10.65" spread="0.968"/>
                    <measurement group_id="O3" value="8.45" spread="0.636"/>
                    <measurement group_id="O4" value="2.25" spread="0.451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: CRP</title>
        <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline; Session 2: Post challenge Day 1; Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: CRP</title>
          <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood</title>
        <description>Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
        <time_frame>Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood</title>
          <description>Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Mean fluorescence intensity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-117.5000" spread="55.86144"/>
                    <measurement group_id="O2" value="-10.5565" spread="50.64061"/>
                    <measurement group_id="O3" value="-47.0000" spread="39.59798"/>
                    <measurement group_id="O4" value="-26.3505" spread="10.83082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-128.9500" spread="131.45115"/>
                    <measurement group_id="O2" value="-31.4965" spread="41.99141"/>
                    <measurement group_id="O3" value="-76.6000" spread="69.29646"/>
                    <measurement group_id="O4" value="-26.6015" spread="13.40656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-130.1500" spread="78.98383"/>
                    <measurement group_id="O2" value="-35.3433" spread="40.19923"/>
                    <measurement group_id="O3" value="-94.3000" spread="56.85139"/>
                    <measurement group_id="O4" value="-29.1195" spread="15.07448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day1,9 hour 40 minutes,n-0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="-24.5510" spread="13.98978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.5000" spread="47.37615"/>
                    <measurement group_id="O2" value="162.8120" spread="171.51836"/>
                    <measurement group_id="O3" value="427.5000" spread="132.22897"/>
                    <measurement group_id="O4" value="42.9945" spread="58.62985"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.5000" spread="40.30509"/>
                    <measurement group_id="O2" value="-6.6285" spread="33.04476"/>
                    <measurement group_id="O3" value="142.5000" spread="71.41778"/>
                    <measurement group_id="O4" value="-11.7065" spread="24.07118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1, 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-371.000" spread="199.4041"/>
                    <measurement group_id="O2" value="-833.203" spread="131.9463"/>
                    <measurement group_id="O3" value="-721.000" spread="131.5219"/>
                    <measurement group_id="O4" value="-511.618" spread="152.8883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-499.500" spread="147.7853"/>
                    <measurement group_id="O2" value="-902.203" spread="205.5423"/>
                    <measurement group_id="O3" value="-790.000" spread="8.4853"/>
                    <measurement group_id="O4" value="-426.253" spread="144.1939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-363.500" spread="112.4300"/>
                    <measurement group_id="O2" value="-694.390" spread="222.5211"/>
                    <measurement group_id="O3" value="-522.500" spread="112.4300"/>
                    <measurement group_id="O4" value="-376.659" spread="156.2613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1, 9 hour 40 minutes,n-0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="-314.464" spread="132.3300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.500" spread="19.0919"/>
                    <measurement group_id="O2" value="146.403" spread="737.3912"/>
                    <measurement group_id="O3" value="22.500" spread="225.5671"/>
                    <measurement group_id="O4" value="-73.247" spread="127.0624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-66.000" spread="8.4853"/>
                    <measurement group_id="O2" value="3.801" spread="244.5535"/>
                    <measurement group_id="O3" value="-80.000" spread="66.4680"/>
                    <measurement group_id="O4" value="63.254" spread="54.8309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1, 40 minutes, n=2,3,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-502.500" spread="171.8269"/>
                    <measurement group_id="O2" value="-892.543" spread="205.7220"/>
                    <measurement group_id="O3" value="86.500" spread="263.7508"/>
                    <measurement group_id="O4" value="932.807" spread="829.8233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1011.000" spread="2743.5743"/>
                    <measurement group_id="O2" value="-583.485" spread="672.1029"/>
                    <measurement group_id="O3" value="-293.500" spread="102.5305"/>
                    <measurement group_id="O4" value="1808.345" spread="1763.3758"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-388.500" spread="74.2462"/>
                    <measurement group_id="O2" value="-686.465" spread="521.9367"/>
                    <measurement group_id="O3" value="12.000" spread="309.7128"/>
                    <measurement group_id="O4" value="2051.872" spread="858.1801"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="2546.884" spread="2810.2028"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="423.000" spread="196.5757"/>
                    <measurement group_id="O2" value="-202.457" spread="181.7519"/>
                    <measurement group_id="O3" value="273.000" spread="407.2935"/>
                    <measurement group_id="O4" value="1724.197" spread="901.9847"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-496.500" spread="422.1427"/>
                    <measurement group_id="O2" value="-469.550" spread="397.5609"/>
                    <measurement group_id="O3" value="-9.500" spread="504.1671"/>
                    <measurement group_id="O4" value="11.054" spread="268.4708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day1, 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.800" spread="109.6016"/>
                    <measurement group_id="O2" value="4.001" spread="37.3132"/>
                    <measurement group_id="O3" value="-9.700" spread="200.1112"/>
                    <measurement group_id="O4" value="-16.194" spread="23.7386"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-78.650" spread="39.1030"/>
                    <measurement group_id="O2" value="-9.406" spread="15.8402"/>
                    <measurement group_id="O3" value="-2.650" spread="9.9702"/>
                    <measurement group_id="O4" value="-10.000" spread="17.4401"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.350" spread="123.2487"/>
                    <measurement group_id="O2" value="-17.622" spread="25.5632"/>
                    <measurement group_id="O3" value="-44.250" spread="85.9135"/>
                    <measurement group_id="O4" value="10.936" spread="32.9481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="-7.284" spread="34.7539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+,Session2,Day2,Pre-fluid sampling,n=2,4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.450" spread="150.6845"/>
                    <measurement group_id="O2" value="-3.732" spread="32.4741"/>
                    <measurement group_id="O3" value="174.850" spread="143.8962"/>
                    <measurement group_id="O4" value="71.592" spread="146.6326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD209+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.630" spread="180.9203"/>
                    <measurement group_id="O2" value="-7.759" spread="29.9928"/>
                    <measurement group_id="O3" value="5.850" spread="122.2588"/>
                    <measurement group_id="O4" value="23.752" spread="61.2399"/>
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              <analyzed_list>
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              <analyzed_list>
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            </class>
            <class>
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              <analyzed_list>
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              <analyzed_list>
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              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4</title>
              <analyzed_list>
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                  <scope>Class</scope>
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              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <scope>Class</scope>
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              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <scope>Class</scope>
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              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80, Session2,Day1,9 hour 40 minutes, n=0,0,0,4</title>
              <analyzed_list>
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                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
              <title>CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
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                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day1, 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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              <category_list>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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              <category_list>
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                    <measurement group_id="O4" value="-694.319" spread="570.1803"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
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                  <scope>Class</scope>
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              <category_list>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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              <category_list>
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                  <measurement_list>
                    <measurement group_id="O1" value="-706.000" spread="1269.9638"/>
                    <measurement group_id="O2" value="-3133.030" spread="1601.2468"/>
                    <measurement group_id="O3" value="-1898.000" spread="733.9768"/>
                    <measurement group_id="O4" value="-764.884" spread="1616.7399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1452.000" spread="366.2813"/>
                    <measurement group_id="O2" value="-2242.108" spread="1155.9978"/>
                    <measurement group_id="O3" value="-1296.500" spread="352.8463"/>
                    <measurement group_id="O4" value="-126.436" spread="774.0775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="798.182" spread="1011.1423"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-171.000" spread="835.8002"/>
                    <measurement group_id="O2" value="924.615" spread="1288.5384"/>
                    <measurement group_id="O3" value="2717.500" spread="2687.7129"/>
                    <measurement group_id="O4" value="904.203" spread="1067.6177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-957.500" spread="514.0666"/>
                    <measurement group_id="O2" value="-978.224" spread="661.5084"/>
                    <measurement group_id="O3" value="-3.000" spread="612.3545"/>
                    <measurement group_id="O4" value="-549.404" spread="673.4385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood</title>
        <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 2: 40 minutes, 2 hour 40 minutes, 5 hour 40 minutes,9hours 40 minutes on Day 1; Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood</title>
          <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood</title>
        <description>Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
        <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O4">
            <title>Part 1: GM-CSF 60 µg/m^2</title>
            <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood</title>
          <description>Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
          <population>Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Mean fluorescence intensity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD16+, Session2,Day1, 40 minutes, n=2, 4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1492.500" spread="1341.3816"/>
                    <measurement group_id="O2" value="-468.314" spread="270.9419"/>
                    <measurement group_id="O3" value="-1418.700" spread="1089.3687"/>
                    <measurement group_id="O4" value="-215.981" spread="31.8638"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day1, 2 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1561.000" spread="1359.0592"/>
                    <measurement group_id="O2" value="-579.984" spread="235.0820"/>
                    <measurement group_id="O3" value="-1495.500" spread="1535.1288"/>
                    <measurement group_id="O4" value="-118.536" spread="142.1664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day1, 5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1061.000" spread="823.0723"/>
                    <measurement group_id="O2" value="-530.365" spread="208.1743"/>
                    <measurement group_id="O3" value="-1334.500" spread="1035.9114"/>
                    <measurement group_id="O4" value="171.104" spread="275.2637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+, Session2,Day1,9 hour 40 minutes,n-0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="265.065" spread="334.2355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+,Session2,Day2, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.500" spread="446.1844"/>
                    <measurement group_id="O2" value="300.333" spread="432.7904"/>
                    <measurement group_id="O3" value="309.500" spread="436.2849"/>
                    <measurement group_id="O4" value="168.661" spread="115.8827"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD16+,Session2,Day3, Pre-fluid sampling, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-564.500" spread="536.6940"/>
                    <measurement group_id="O2" value="1116.482" spread="840.6096"/>
                    <measurement group_id="O3" value="984.000" spread="130.1076"/>
                    <measurement group_id="O4" value="4.757" spread="149.9929"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1, 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.0000" spread="65.05382"/>
                    <measurement group_id="O2" value="-3.8803" spread="39.59977"/>
                    <measurement group_id="O3" value="-160.5000" spread="152.02796"/>
                    <measurement group_id="O4" value="58.3640" spread="66.82273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1,2 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.5000" spread="31.81981"/>
                    <measurement group_id="O2" value="-28.0153" spread="33.20632"/>
                    <measurement group_id="O3" value="-187.5500" spread="156.34131"/>
                    <measurement group_id="O4" value="47.3110" spread="48.31955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1,5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0000" spread="87.68124"/>
                    <measurement group_id="O2" value="13.7295" spread="38.55623"/>
                    <measurement group_id="O3" value="-41.5000" spread="101.11627"/>
                    <measurement group_id="O4" value="-12.9720" spread="77.32898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+, Session2,Day1, 9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="-24.0198" spread="66.75178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+,Session2,Day2, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.0000" spread="35.35534"/>
                    <measurement group_id="O2" value="68.9850" spread="76.56191"/>
                    <measurement group_id="O3" value="239.0000" spread="11.31371"/>
                    <measurement group_id="O4" value="-19.7730" spread="57.09070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD163+,Session2,Day3, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0000" spread="50.91169"/>
                    <measurement group_id="O2" value="175.6860" spread="104.35800"/>
                    <measurement group_id="O3" value="88.5000" spread="27.57716"/>
                    <measurement group_id="O4" value="-10.6642" spread="38.84898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1, 40 minutes, n=2,2,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-75.000" spread="130.1076"/>
                    <measurement group_id="O2" value="-140.156" spread="160.1010"/>
                    <measurement group_id="O3" value="241.000" spread="22.6274"/>
                    <measurement group_id="O4" value="552.855" spread="259.4200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1,2 hour 40 minutes, n=2,2,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="570.500" spread="164.7559"/>
                    <measurement group_id="O2" value="-130.065" spread="141.4567"/>
                    <measurement group_id="O3" value="124.000" spread="229.1026"/>
                    <measurement group_id="O4" value="444.094" spread="454.3525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1,5 hour 40 minutes, n=2,2,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.500" spread="106.7731"/>
                    <measurement group_id="O2" value="-84.217" spread="161.6658"/>
                    <measurement group_id="O3" value="0.500" spread="215.6676"/>
                    <measurement group_id="O4" value="262.268" spread="126.1299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="275.423" spread="163.9991"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD206+,Session2,Day2, Pre-fluid sampling,n=2,2,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
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            </class>
            <class>
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              <analyzed_list>
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                  <scope>Class</scope>
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              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
              <title>CD40, Session2,Day2, Pre-fluid sampling,n=2,4, 2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD80,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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              </category_list>
            </class>
            <class>
              <title>CD80,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day1, 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
              <title>CD83, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
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              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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              <category_list>
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                </category>
              </category_list>
            </class>
            <class>
              <title>CD83,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
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                  <units>Participants</units>
                  <scope>Class</scope>
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                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day1, 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
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                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-93.5000" spread="21.92031"/>
                    <measurement group_id="O2" value="-101.1600" spread="78.03703"/>
                    <measurement group_id="O3" value="56.0000" spread="29.69848"/>
                    <measurement group_id="O4" value="8.9678" spread="29.25980"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day1,2 hour 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0000" spread="250.31580"/>
                    <measurement group_id="O2" value="-121.3668" spread="68.34453"/>
                    <measurement group_id="O3" value="-144.5000" spread="28.99138"/>
                    <measurement group_id="O4" value="30.0005" spread="101.61342"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day1,5 hour 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.5000" spread="40.30509"/>
                    <measurement group_id="O2" value="-94.3938" spread="35.37430"/>
                    <measurement group_id="O3" value="-44.0000" spread="214.96046"/>
                    <measurement group_id="O4" value="106.9465" spread="53.12949"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="118.6338" spread="49.28502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+,Session2,Day2, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5000" spread="75.66043"/>
                    <measurement group_id="O2" value="126.1853" spread="105.91022"/>
                    <measurement group_id="O3" value="194.5000" spread="13.43503"/>
                    <measurement group_id="O4" value="83.4098" spread="63.12670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD86+,Session2,Day3, Pre-fluid sampling,n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-91.0000" spread="32.52691"/>
                    <measurement group_id="O2" value="117.9230" spread="55.75943"/>
                    <measurement group_id="O3" value="82.0000" spread="94.75231"/>
                    <measurement group_id="O4" value="15.2970" spread="75.45627"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day1, 40 minutes, n=2, 4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="445.50" spread="434.871"/>
                    <measurement group_id="O2" value="896.74" spread="1309.134"/>
                    <measurement group_id="O3" value="41096.00" spread="47912.141"/>
                    <measurement group_id="O4" value="-2795.55" spread="2243.871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day1,2 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2457.50" spread="775.696"/>
                    <measurement group_id="O2" value="-1417.49" spread="1937.407"/>
                    <measurement group_id="O3" value="-5430.00" spread="5929.797"/>
                    <measurement group_id="O4" value="-1430.37" spread="2743.193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day1,5 hour 40 minutes, n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-320.00" spread="523.259"/>
                    <measurement group_id="O2" value="-1744.11" spread="2077.874"/>
                    <measurement group_id="O3" value="-1604.00" spread="3859.389"/>
                    <measurement group_id="O4" value="-1347.06" spread="2935.540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR, Session2,Day1,9 hour 40 minutes,n=0,0,0,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="-943.38" spread="4035.982"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR,Session2,Day2, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1449.00" spread="1571.191"/>
                    <measurement group_id="O2" value="688.02" spread="1710.854"/>
                    <measurement group_id="O3" value="-2085.00" spread="4775.799"/>
                    <measurement group_id="O4" value="800.49" spread="2738.323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HLA-DR,Session2,Day3, Pre-fluid sampling,n=2,4,2,4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2292.50" spread="416.486"/>
                    <measurement group_id="O2" value="-2030.80" spread="2398.091"/>
                    <measurement group_id="O3" value="-6379.00" spread="9237.643"/>
                    <measurement group_id="O4" value="113.79" spread="2769.699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood</title>
        <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood</title>
          <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm</title>
        <description>Blood samples were collected at indicated time-points for analysis of leukocyte. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
        <time_frame>Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: LPS 0.5 ng/kg</title>
            <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: LPS 0.75 ng/kg</title>
            <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
          <group group_id="O3">
            <title>Part 1: LPS 1 ng/kg</title>
            <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm</title>
          <description>Blood samples were collected at indicated time-points for analysis of leukocyte. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.</description>
          <population>Safety Population.</population>
          <units>Cells per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Session2, Day 1, 40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-358893.71" spread="1002862.023"/>
                    <measurement group_id="O2" value="-1477705.00" spread="811560.729"/>
                    <measurement group_id="O3" value="-2065961.83" spread="1083290.576"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 1, 2 hours 40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3347754.14" spread="1701524.775"/>
                    <measurement group_id="O2" value="2423233.00" spread="2047535.993"/>
                    <measurement group_id="O3" value="5224467.23" spread="800613.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 1, 5 hours 40 minutes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2116748.36" spread="3209541.020"/>
                    <measurement group_id="O2" value="4511414.25" spread="3044446.191"/>
                    <measurement group_id="O3" value="3641780.22" spread="1458532.473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 2, Pre-fluid sample</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-447452.27" spread="101410.586"/>
                    <measurement group_id="O2" value="881299.75" spread="1640158.830"/>
                    <measurement group_id="O3" value="442226.68" spread="232936.722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Session2, Day 3, Pre-fluid sample</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-169328.51" spread="21593.240"/>
                    <measurement group_id="O2" value="-93685.25" spread="1383413.608"/>
                    <measurement group_id="O3" value="75348.31" spread="927892.867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm</title>
        <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With LPS</title>
            <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm</title>
          <description>Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF</title>
        <description>Blood samples were planned to be collected at indicated time-points for analysis of white blood cells. Baseline value is Session 2 Day 1. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
        <time_frame>Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3</time_frame>
        <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Participants With GM-CSF</title>
            <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF</title>
          <description>Blood samples were planned to be collected at indicated time-points for analysis of white blood cells. Baseline value is Session 2 Day 1. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.</description>
          <population>Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment until 69 days in Part 1 of the study.</time_frame>
      <desc>AEs and SAEs were collected in Part 1 for Safety Population. Data was not collected for Part 2 as participants were not enrolled for Part 2.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: LPS 0.5 ng/kg</title>
          <description>Participants were randomized to receive 0.5 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="E2">
          <title>Part 1: LPS 0.75 ng/kg</title>
          <description>Participants were randomized to receive 0.75 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="E3">
          <title>Part 1: LPS 1 ng/kg</title>
          <description>Participants were randomized to receive 1 ng/kg LPS as intravenous injection. After administration of LPS participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="E4">
          <title>Part 1: GM-CSF 60 µg/m^2</title>
          <description>Participants were randomized to receive 60 µg/m^2 GM-CSF IV infusion. After administration of GM-CSF participant had two blisters induced on each arm followed by blood sample collection.</description>
        </group>
        <group group_id="E5">
          <title>Part 2: Participants With LPS</title>
          <description>Participants were planned to be dosed with LPS (0.5 with possible escalation up to 4 ng/kg) during Part 2 of the study</description>
        </group>
        <group group_id="E6">
          <title>Part 2: Participants With GM-CSF</title>
          <description>Participants were planned to be dosed with GM-CSF (60 to a maximum dose of 480 µg/m^2) during Part 2 of the study.</description>
        </group>
      </group_list>
      <serious_events>
        <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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <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="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Reponse Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343 ext 1</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03306589
org study id: 207654
nct id: NCT03306589
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This exploratory study aims to assess exposure of healthy subjects to systemic challenge with
      either LPS or GM-CSF. This will be done by measuring inflammatory mediators and cellular
      activation markers both in circulation and in skin blisters induced by exposure to
      cantharidin (an agent that causes blisters). LPS is often used to induce inflammation whereas
      GM-CSF is a cytokine and a key mediator in inflammatory diseases. In this 2 parts study,
      subjects will have 2 sessions in each part. Part I of the study is a dose-exploration phase
      and part II will be a continuation phase to draw more precise outcomes. In session 1,
      subjects will be randomized to receive either LPS or GM-CSF and will have 2 blisters induced
      on each forearm followed by blood draws and a blister harvest on each forearm at 24 and 48
      hours post-induction. After a minimum of 14 days blister healing period, subjects will return
      for session 2. In part I, Up to 6 cohorts will be tested and all cohorts will have 2
      sessions. For Part I, initially Cohort 1 will proceed with session 1. After their blister
      healing period, Cohort 1 will return for their session 2 visit in two groups (Group A and
      Group B) on different days. Group A will be dosed on the same day (one with LPS and one with
      GM-CSF) and Group B will be dosed on a different day (one with LPS and one with GM-CSF) after
      group A. Dose-escalation in Cohort 2-6 will be continued until the well tolerated dose has
      been determined. The same dose will be administered to an additional Cohort in Part II and
      the same 2-session design will be used. Approximately 24-30 healthy subjects will be enrolled
      for the study and the total duration of the study for each subject will be approximately 13
      weeks from screening to follow up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects in 2 separate groups will be randomized to receive either LPS or GM-CSF at the same time.
primary purpose: Diagnostic
masking: None (Open Label)
masking description: This will be an open label study and no masking will be performed.
measure: Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm
time frame: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes,5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Each session was for three days. NA indicates that data was not available as standard deviation could not be calculated for a single participant. All participants who were randomized to receive the treatment (LPS or GM-CSF challenge) and received one dose of challenge agent were included in Safety Population.
measure: Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm
time frame: Baseline, Session 2 Day 1
description: The post-challenge urine samples were collected during session 2 after LPS challenge. In session 2, participants were encouraged to pass urine immediately before LPS challenge dose and urine voids were collected from after LPS until 12 hours post-LPS and the time of the urine collection were recorded as post-challenge 1 to 11. These samples were collected for measurement of tetranor-PGDM. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. The data for normalized Tetranor PGDM was normalized by (Tetranor PGDM [pg/mL] divided by Creatinine [milligram per deciliter]) multiplied by 100. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm
time frame: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm
time frame: Baseline, Session 2 Day 1
description: Urine samples were planned to be collected for analysis. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF
time frame: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated time-points for analysis of white blood cells. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.
measure: Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF
time frame: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated time-points for analysis of white blood cells. Baseline value is Session 2 Day 1. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister
time frame: Baseline; Session1: 48 hours on Day3; Session 2: 24 hours on Day 2 and 48 hours on Day 3
description: Blister samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta (b), Interferon-gamma (INFg), IL-6, IL-2, IL-8, Monocyte chemotactic protein-1 (MCP-1) and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2: Change From Baseline Soluble Inflammatory Biomarkers in Skin Blister
time frame: Baseline; Session1: 48 hours Day3; Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for the analysis of soluble inflammatory mediators like IL-1 beta, INFg, IL-6, IL-2, IL-8, MCP-1 and TNF-alpha. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Absolute Values of Blister Volume
time frame: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3
description: Blister samples were collected at indicated time-points for analysis of blister volumes. . Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline.
measure: Part 2: Absolute Values of Blister Volume
time frame: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for analysis of blister volumes. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline in Cell Numbers in Blister
time frame: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3
description: Blister samples were collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.
measure: Part 2: Change From Baseline in Cell Numbers in Blister
time frame: Baseline, Session 1: 48 hours Day 3. Session 2: 24 hours Day 2, 48 hours Day 3
description: Blood samples were planned to be collected at indicated time-points for analysis of white blood cell in blister. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister. Activation markers included Cluster of Differentiation (CD) 16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and Human Leukocyte Antigen - antigen D Related (HLA-DR). Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Monocytes in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister
time frame: Baseline; Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Dendritic Cells in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for macrophages in blister. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2:Change From Baseline in Cell Activation Markers by Flow Cytometry on Macrophages in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blister like CD40+/CD80+. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2:Change From Baseline of CD40+/CD80+ by Flow Cytometry on Macrophages in Blister
time frame: Baseline, Session1: 48 hours Day 3, Session 2: 24 hours Day 2 and 48 hours Day 3
description: Blister samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1:Change From Baseline in Soluble Inflammatory Mediators in Blood
time frame: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like IL-1 beta, INFg, IL-2, IL-8, and MCP-1 in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. NA indicates that data was not available as standard deviation could not be calculated for a single participant.
measure: Part 2:Change From Baseline in Soluble Inflammatory Mediators in Blood
time frame: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF: GM-CSF Arm
time frame: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like TNF-alpha, IL-6 and GM-CSF in blood. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.
measure: Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: TNF-alpha, IL-6 and GM-CSF for GM-CSF Arm
time frame: Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline in Soluble Inflammatory Mediators in Blood: C-reactive Protein (CRP)
time frame: Baseline; Session 2: Post challenge Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated time-points for the analysis of soluble inflammatory mediators like CRP in blood. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.
measure: Part 2: Change From Baseline in Soluble Inflammatory Mediators in Blood: CRP
time frame: Baseline; Session 2: Post challenge Day 1; Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood
time frame: Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for monocytes in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.
measure: Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Monocytes in Blood
time frame: Baseline, Session 2: 40 minutes, 2 hour 40 minutes, 5 hour 40 minutes,9hours 40 minutes on Day 1; Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood
time frame: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated time-points for the measurement of activation markers by flow cytometry for dendritic cells in blood. Activation markers included CD16, CD163, CD206, CD209, CD40, CD80, CD83, CD86 and HLA-DR. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.
measure: Part 2: Change From Baseline in Cell Activation Markers by Flow Cytometry on Dendritic Cells in Blood
time frame: Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge (LPS or GM-CSF) assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
measure: Part 1: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm
time frame: Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were collected at indicated time-points for analysis of leukocyte. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value.
measure: Part 2: Change From Baseline in Circulating Leukocyte Numbers in Blood: LPS Arm
time frame: Baseline; Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
description: Blood samples were planned to be collected at indicated time-points for the measurement of activation. Latest pre-challenge assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved.
arm group label: Subjects receiving LPS: Part I and Part II
arm group type: Experimental
description: Eligible subjects will be randomized to receive LPS in a dose-escalation manner ranging from 0.5 nanogram (ng)/kg to 4 ng/kg. Subjects will be hydrated prior to administration of LPS with normal saline at a rate of 250 mL/hour for 4 hours prior to dosing and 8 hours after dosing.
arm group label: Subjects receiving GM-CSF: Part I and Part II
arm group type: Experimental
description: Eligible subjects will be randomized to receive GM-CSF in a dose-escalation manner ranging from 5 to 15 microgram (µg)/kg.
intervention type: Biological
intervention name: Cantharidin
description: 5 microliter (µL) of 0.2 percent Cantharidin solution (diluted in acetone) will be applied to all subjects on forearm by topical route.
arm group label: Subjects receiving GM-CSF: Part I and Part II
arm group label: Subjects receiving LPS: Part I and Part II
intervention type: Biological
intervention name: Lipopolysaccharide
description: 0.5 to 4 ng/kg body weight of LPS formulated as suspension in normal saline will be administered to randomized subjects via intravenous (IV) route in dose-escalation manner.
arm group label: Subjects receiving LPS: Part I and Part II
intervention type: Biological
intervention name: Granulocyte-Macrophage Colony-Stimulating Factor
description: 5 to 15 µg/kg of GM-CSF will be administered to randomized subjects via subcutaneous (SC) route in the abdominal region in dose-escalation manner.
arm group label: Subjects receiving GM-CSF: Part I and Part II
intervention type: Drug
intervention name: Saline Solution
description: 0.9 percent sodium chloride will be administered via IV route to all subjects at a rate of 250 mL/hour for 4 hours prior to dosing with LPS and 8 hours after dosing with LPS.
arm group label: Subjects receiving LPS: Part I and Part II
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Arthritis, Rheumatoid
mesh term: Molgramostim
mesh term: Sargramostim
mesh term: Cantharidin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 