<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/NCT03257358</url>
  </required_header>
  <id_info>
    <org_study_id>CFTY720DUS40</org_study_id>
    <nct_id>NCT03257358</nct_id>
  </id_info>
  <brief_title>A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod</brief_title>
  <acronym>FLUENT</acronym>
  <official_title>A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)&#xD;
      after treatment with 0.5mg fingolimod&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study used a 2-cohort, nonrandomized, open-label, multicenter design. Cohort 1: The&#xD;
      first cohort was to be comprised of approximately 200 patients with RMS, who were newly&#xD;
      prescribed commercially available fingolimod 0.5 mg/day. Cohort 2: The second cohort was to&#xD;
      be comprised of approximately 200 RMS patients who had been on commercially available&#xD;
      fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years.&#xD;
      Patients from both cohorts were recruited simultaneously from up to 125 MS centers in the&#xD;
      United States. Both cohorts ran concurrently. The study consisted of 2 periods: Screening (up&#xD;
      to 4 weeks) and Treatment period from Baseline (end of screening period considered as Day 1)&#xD;
      up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post&#xD;
      treatment..&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">June 28, 2019</completion_date>
  <primary_completion_date type="Actual">March 5, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two-cohort, non-randomized, open-label multicenter</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Monocytes (CD14+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Neutrophils (CD16+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in NK Cells (CD56+)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Total CD4+ Differential Cell Count</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)</measure>
    <time_frame>Baseline to Month 6</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Monocytes (CD14+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Neutrophils (CD16+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in NK Cells (CD56+)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Sclerosis (MS) Relapses During Treatment</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (&lt;37.5°C) or infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (&lt;37.5°C) or infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Determined Disease Steps (PDDS)</measure>
    <time_frame>Baseline to Month 12</time_frame>
    <description>PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in T2 Lesion Burden</measure>
    <time_frame>Baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline for New Gd-Enhancing T1 Lesion Count</measure>
    <time_frame>Baseline to Month 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)</measure>
    <time_frame>Baseline to Month 6 and 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">382</enrollment>
  <condition>Relapsing Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fingolimod</intervention_name>
    <description>Commercially available 0.5mg hard capsules, taken orally once per day</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of relapsing forms of Multiple Sclerosis&#xD;
&#xD;
          -  Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR&#xD;
             patients already on commercially prescribed fingolimod 0.5mg per day continuously for&#xD;
             ≥ 2 years&#xD;
&#xD;
        Exclusion Criteria (per USPI):&#xD;
&#xD;
          -  Patients who in the last 6 months experienced myocardial infarction, unstable angina,&#xD;
             stroke, transient ischemic stroke, decompensated heart failure requiring&#xD;
             hospitalization or Class III/IV heart failure&#xD;
&#xD;
          -  History or presence of Mobitz Type II second-degree or third-degree atrioventricular&#xD;
             block or sick sinus syndrome, unless patient had a functioning pacemaker&#xD;
&#xD;
          -  Baseline QTc interval ≥ 500 msec&#xD;
&#xD;
          -  Treatment with Class Ia or Class III anti-arrhythmic drugs&#xD;
&#xD;
          -  Patients who had a hypersensitivity reaction to fingolimod or any of the excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cullman</city>
        <state>Alabama</state>
        <zip>35058</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85718</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94705</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Louisville</city>
        <state>Colorado</state>
        <zip>80027</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33482</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
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        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
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  <location>
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        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33952</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34243</zip>
        <country>United States</country>
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  <location>
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      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Vero Beach</city>
        <state>Florida</state>
        <zip>32960</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Suwanee</city>
        <state>Georgia</state>
        <zip>30024</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Flossmoor</city>
        <state>Illinois</state>
        <zip>60422</zip>
        <country>United States</country>
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  <location>
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      <address>
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        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
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  <location>
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      <address>
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        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
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  <location>
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      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Foxboro</city>
        <state>Massachusetts</state>
        <zip>02035</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lexington</city>
        <state>Massachusetts</state>
        <zip>02421</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wellesley</city>
        <state>Massachusetts</state>
        <zip>02481</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Owosso</city>
        <state>Michigan</state>
        <zip>48867</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Golden Valley</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fair Lawn</city>
        <state>New Jersey</state>
        <zip>07410</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Livingston</city>
        <state>New Jersey</state>
        <zip>07039</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Patchogue</city>
        <state>New York</state>
        <zip>11772</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Plainview</city>
        <state>New York</state>
        <zip>11803</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28806</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45408</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Westerville</city>
        <state>Ohio</state>
        <zip>43081</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73102</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Port Royal</city>
        <state>South Carolina</state>
        <zip>29935</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22043</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vienna</city>
        <state>Virginia</state>
        <zip>22182</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
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  <location>
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      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25701</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54311</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Neenah</city>
        <state>Wisconsin</state>
        <zip>54956</zip>
        <country>United States</country>
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    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=558</url>
    <description>A Plain Language Trial Summary is available on novartisclinicaltrials.com</description>
  </link>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>June 26, 2020</results_first_submitted>
  <results_first_submitted_qc>June 26, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 21, 2020</results_first_posted>
  <disposition_first_submitted>June 11, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>June 11, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 13, 2019</disposition_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsing Multiple Sclerosis</keyword>
  <keyword>RMS</keyword>
  <keyword>Relapsing Multiple Sclerosis (RMS)</keyword>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>MS</keyword>
  <keyword>Multiple Sclerosis (MS)</keyword>
  <keyword>Fingolimod</keyword>
  <keyword>FLUENT</keyword>
  <keyword>Immune Phenotype</keyword>
  <keyword>adult</keyword>
  <keyword>FTY720</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fingolimod Hydrochloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
    <ipd_url>https://www.clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03257358/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>September 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03257358/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>165 patients were enrolled but only 163 were treated and included in the Safety Set</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2</title>
          <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="165"/>
                <participants group_id="P2" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Never Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="183"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with fingolimod treatment</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Technical problems</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of informed consent</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>New therapy for study indication</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer requires treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>There were 165 participants enrolled in the trial but 2 participants in Cohort 1 never received treatment</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
          <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2</title>
          <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="163"/>
            <count group_id="B2" value="217"/>
            <count group_id="B3" value="380"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.8" spread="10.72"/>
                    <measurement group_id="B2" value="48.9" spread="9.94"/>
                    <measurement group_id="B3" value="45.9" spread="10.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="285"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from Multiple Sclerosis Diagnosis until study treamtent</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="163"/>
                    <count group_id="B2" value="217"/>
                    <count group_id="B3" value="380"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.78" spread="7.984"/>
                    <measurement group_id="B2" value="12.94" spread="7.007"/>
                    <measurement group_id="B3" value="10.30" spread="8.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Patients with Relaspses within the last year</title>
          <population>Missing data for some participants</population>
          <units>Number of patients with relapse</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Number of patients with at least 1 relapse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="215"/>
                    <count group_id="B3" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of patients with no relapse</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="162"/>
                    <count group_id="B2" value="215"/>
                    <count group_id="B3" value="377"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="183"/>
                    <measurement group_id="B3" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="404.4" spread="273.56"/>
                    <measurement group_id="O2" value="3.4" spread="20.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="38.04"/>
                    <measurement group_id="O2" value="4.8" spread="23.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6, n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-411.4" spread="273.31"/>
                    <measurement group_id="O2" value="0.8" spread="25.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-413.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>4.7</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-422.7</ci_lower_limit>
            <ci_upper_limit>-404.</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>3.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="374.6" spread="216.36"/>
                    <measurement group_id="O2" value="16.3" spread="45.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" spread="58.77"/>
                    <measurement group_id="O2" value="18.3" spread="42.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6, n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-368.9" spread="218.40"/>
                    <measurement group_id="O2" value="1.1" spread="51.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-368.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.08</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-382.8</ci_lower_limit>
            <ci_upper_limit>354.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.1</ci_lower_limit>
            <ci_upper_limit>6.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3" spread="43.56"/>
                    <measurement group_id="O2" value="22.8" spread="41.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" spread="23.00"/>
                    <measurement group_id="O2" value="21.7" spread="33.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-51.5" spread="36.24"/>
                    <measurement group_id="O2" value="-2.0" spread="31.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-52.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.58</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-57.2</ci_lower_limit>
            <ci_upper_limit>-46.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-3.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.27</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.6</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=148,211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8" spread="38.29"/>
                    <measurement group_id="O2" value="11.1" spread="31.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=104,180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="15.12"/>
                    <measurement group_id="O2" value="11.7" spread="33.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=104,180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-43.6" spread="32.51"/>
                    <measurement group_id="O2" value="-0.7" spread="14.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-43.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.67</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-46.9</ci_lower_limit>
            <ci_upper_limit>-40.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.18</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.0</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=148,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" spread="30.06"/>
                    <measurement group_id="O2" value="1.1" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=104,181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="4.17"/>
                    <measurement group_id="O2" value="1.6" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=104,181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.1" spread="32.42"/>
                    <measurement group_id="O2" value="0.5" spread="5.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-36.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.48</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.2</ci_lower_limit>
            <ci_upper_limit>-35.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=148,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" spread="36.60"/>
                    <measurement group_id="O2" value="2.4" spread="5.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=104,181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="8.38"/>
                    <measurement group_id="O2" value="2.8" spread="6.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=104,181</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="104"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.2" spread="39.01"/>
                    <measurement group_id="O2" value="0.5" spread="6.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-53.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-55.1</ci_lower_limit>
            <ci_upper_limit>-51.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.51</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.9" spread="119.48"/>
                    <measurement group_id="O2" value="1.8" spread="8.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="22.00"/>
                    <measurement group_id="O2" value="3.3" spread="15.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-139.3" spread="113.25"/>
                    <measurement group_id="O2" value="1.2" spread="14.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-140.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-145.8</ci_lower_limit>
            <ci_upper_limit>-135.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>3.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1" spread="75.22"/>
                    <measurement group_id="O2" value="5.6" spread="14.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="16.42"/>
                    <measurement group_id="O2" value="6.1" spread="12.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-85.2" spread="67.95"/>
                    <measurement group_id="O2" value="0.0" spread="15.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-85.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.92</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-89.0</ci_lower_limit>
            <ci_upper_limit>-81.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.2" spread="93.28"/>
                    <measurement group_id="O2" value="63.8" spread="115.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.4" spread="102.88"/>
                    <measurement group_id="O2" value="52.6" spread="40.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=97,156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.6" spread="103.03"/>
                    <measurement group_id="O2" value="-12.5" spread="116.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-27.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.65</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.1</ci_lower_limit>
            <ci_upper_limit>-4.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-9.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.3</ci_lower_limit>
            <ci_upper_limit>-2.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=144,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201.1" spread="134.16"/>
                    <measurement group_id="O2" value="18.1" spread="33.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=101,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" spread="10.50"/>
                    <measurement group_id="O2" value="17.8" spread="19.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=101,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-181.4" spread="125.71"/>
                    <measurement group_id="O2" value="-0.2" spread="36.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-181.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-183.3</ci_lower_limit>
            <ci_upper_limit>-179.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.1</ci_lower_limit>
            <ci_upper_limit>2.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=144,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.8" spread="74.29"/>
                    <measurement group_id="O2" value="3.3" spread="22.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=101,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="6.24"/>
                    <measurement group_id="O2" value="4.0" spread="21.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=101,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.1" spread="74.36"/>
                    <measurement group_id="O2" value="0.3" spread="6.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-55.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-56.5</ci_lower_limit>
            <ci_upper_limit>-53.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.42</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=144,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="12.88"/>
                    <measurement group_id="O2" value="5.3" spread="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=101,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="3.92"/>
                    <measurement group_id="O2" value="6.1" spread="5.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=101,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="101"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.4" spread="10.64"/>
                    <measurement group_id="O2" value="0.9" spread="8.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-7.2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.40</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.0</ci_lower_limit>
            <ci_upper_limit>-6.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>1.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.3</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Monocytes (CD14+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Monocytes (CD14+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=150,197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329.6" spread="167.52"/>
                    <measurement group_id="O2" value="251.7" spread="118.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=105,166</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="384.7" spread="148.76"/>
                    <measurement group_id="O2" value="379.2" spread="131.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=105,166</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.1" spread="139.24"/>
                    <measurement group_id="O2" value="123.1" spread="123.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>69.4</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>13.78</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>42.1</ci_lower_limit>
            <ci_upper_limit>96.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>117.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.07</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>97.1</ci_lower_limit>
            <ci_upper_limit>136.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Neutrophils (CD16+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Neutrophils (CD16+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=149,197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4041.4" spread="1576.73"/>
                    <measurement group_id="O2" value="3717.9" spread="1552.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=105,166</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3505.4" spread="1512.81"/>
                    <measurement group_id="O2" value="3312.6" spread="1311.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=105,166</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-586.0" spread="1463.26"/>
                    <measurement group_id="O2" value="-439.6" spread="1274.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-782.6</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>138.90</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1058.2</ci_lower_limit>
            <ci_upper_limit>-507.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-485.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>91.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-667.3</ci_lower_limit>
            <ci_upper_limit>-304.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in NK Cells (CD56+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in NK Cells (CD56+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=149,197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.4" spread="98.23"/>
                    <measurement group_id="O2" value="181.0" spread="113.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=105,166</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.6" spread="83.41"/>
                    <measurement group_id="O2" value="154.5" spread="88.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=105,166</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="166"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.4" spread="76.42"/>
                    <measurement group_id="O2" value="-28.0" spread="81.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-33.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-48.2</ci_lower_limit>
            <ci_upper_limit>-18.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-25.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.52</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-36.7</ci_lower_limit>
            <ci_upper_limit>-14.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=156,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="936.3" spread="443.31"/>
                    <measurement group_id="O2" value="64.4" spread="122.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=110,182</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.4" spread="114.61"/>
                    <measurement group_id="O2" value="71.3" spread="112.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=110,182</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-884.1" spread="440.65"/>
                    <measurement group_id="O2" value="1.4" spread="105.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-888.7</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>13.10</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-914.6</ci_lower_limit>
            <ci_upper_limit>-862.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-3.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.24</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.6</ci_lower_limit>
            <ci_upper_limit>11.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Total CD4+ Differential Cell Count</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Total CD4+ Differential Cell Count</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=157,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.40" spread="10.115"/>
                    <measurement group_id="O2" value="11.95" spread="12.637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=111,183</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.08" spread="9.875"/>
                    <measurement group_id="O2" value="12.82" spread="13.687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=111,183</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.09" spread="12.052"/>
                    <measurement group_id="O2" value="0.32" spread="6.119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-39.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.053</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.59</ci_lower_limit>
            <ci_upper_limit>-37.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.14</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.510</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.87</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=156,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="419.9" spread="257.71"/>
                    <measurement group_id="O2" value="124.6" spread="213.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=110,182</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.1" spread="148.82"/>
                    <measurement group_id="O2" value="116.8" spread="101.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=110,182</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-266.2" spread="209.45"/>
                    <measurement group_id="O2" value="-13.5" spread="205.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-248.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>15.00</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-278.7</ci_lower_limit>
            <ci_upper_limit>-219.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-9.9</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.1</ci_lower_limit>
            <ci_upper_limit>5.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=157,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.86" spread="7.852"/>
                    <measurement group_id="O2" value="25.25" spread="14.406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=111,183</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.33" spread="14.998"/>
                    <measurement group_id="O2" value="24.99" spread="13.863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="111"/>
                    <count group_id="O2" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.63" spread="11.327"/>
                    <measurement group_id="O2" value="-0.39" spread="4.528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>5.60</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.249</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.13</ci_lower_limit>
            <ci_upper_limit>8.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.364</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.68</ci_lower_limit>
            <ci_upper_limit>0.76</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=151,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259.7" spread="167.94"/>
                    <measurement group_id="O2" value="21.4" spread="45.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=106,179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.5" spread="15.91"/>
                    <measurement group_id="O2" value="21.8" spread="34.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=106,179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-231.3" spread="153.49"/>
                    <measurement group_id="O2" value="0.1" spread="40.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-231.0</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.75</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-234.5</ci_lower_limit>
            <ci_upper_limit>-227.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.45</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>4.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 6</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=152,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.97" spread="7.245"/>
                    <measurement group_id="O2" value="4.81" spread="5.294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6 n=107,180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.38" spread="4.368"/>
                    <measurement group_id="O2" value="4.83" spread="5.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=107,180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="107"/>
                    <count group_id="O2" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.53" spread="6.723"/>
                    <measurement group_id="O2" value="0.23" spread="3.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>-8.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.455</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.21</ci_lower_limit>
            <ci_upper_limit>-7.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Estimation</non_inferiority_desc>
            <param_type>least squares mean</param_type>
            <param_value>0.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.251</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.17</ci_lower_limit>
            <ci_upper_limit>0.82</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="404.4" spread="273.56"/>
                    <measurement group_id="O2" value="3.4" spread="20.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=82,150</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-376.3" spread="277.23"/>
                    <measurement group_id="O2" value="-0.8" spread="20.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="374.6" spread="216.36"/>
                    <measurement group_id="O2" value="16.3" spread="45.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=83,150</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-356.8" spread="237.76"/>
                    <measurement group_id="O2" value="3.9" spread="55.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3" spread="43.56"/>
                    <measurement group_id="O2" value="22.8" spread="41.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=83,150</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-50.4" spread="40.40"/>
                    <measurement group_id="O2" value="-3.3" spread="30.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=148,211</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8" spread="38.29"/>
                    <measurement group_id="O2" value="11.1" spread="31.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=88,175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-42.3" spread="38.9"/>
                    <measurement group_id="O2" value="-2.1" spread="15.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=148,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" spread="30.06"/>
                    <measurement group_id="O2" value="1.1" spread="4.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.3" spread="34.63"/>
                    <measurement group_id="O2" value="0.4" spread="4.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=148,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" spread="36.60"/>
                    <measurement group_id="O2" value="2.4" spread="5.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=88,175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-52.1" spread="41.20"/>
                    <measurement group_id="O2" value="0.5" spread="7.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.9" spread="119.48"/>
                    <measurement group_id="O2" value="1.8" spread="8.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=83,150</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-126.3" spread="103.38"/>
                    <measurement group_id="O2" value="0.6" spread="10.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1" spread="75.22"/>
                    <measurement group_id="O2" value="5.6" spread="14.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=83,150</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-86.5" spread="75.75"/>
                    <measurement group_id="O2" value="0.0" spread="16.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=147,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="147"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.2" spread="93.28"/>
                    <measurement group_id="O2" value="63.8" spread="115.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=83,150</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.9" spread="57.48"/>
                    <measurement group_id="O2" value="-15.9" spread="122.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=144,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="201.11" spread="134.16"/>
                    <measurement group_id="O2" value="18.1" spread="33.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=82,174</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-177.0" spread="114.43"/>
                    <measurement group_id="O2" value="-0.5" spread="40.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=144,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.8" spread="74.29"/>
                    <measurement group_id="O2" value="3.3" spread="22.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=82,174</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.4" spread="39.15"/>
                    <measurement group_id="O2" value="1.4" spread="19.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=144,212</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="144"/>
                    <count group_id="O2" value="212"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="12.88"/>
                    <measurement group_id="O2" value="5.3" spread="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=82,174</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.7" spread="11.60"/>
                    <measurement group_id="O2" value="0.8" spread="8.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Monocytes (CD14+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Monocytes (CD14+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=150,197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="150"/>
                    <count group_id="O2" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="329.6" spread="167.52"/>
                    <measurement group_id="O2" value="251.7" spread="118.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=86,164</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" spread="139.91"/>
                    <measurement group_id="O2" value="112.4" spread="130.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Neutrophils (CD16+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Neutrophils (CD16+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=149,197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4041.4" spread="1576.73"/>
                    <measurement group_id="O2" value="3717.9" spread="1552.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=87, 164</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-815.9" spread="1368.23"/>
                    <measurement group_id="O2" value="-345.0" spread="1253.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in NK Cells (CD56+)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in NK Cells (CD56+)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=149,197</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="197"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.4" spread="98.23"/>
                    <measurement group_id="O2" value="181.0" spread="113.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=87,164</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="164"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.6" spread="97.86"/>
                    <measurement group_id="O2" value="-28.9" spread="86.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=156,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="936.3" spread="443.31"/>
                    <measurement group_id="O2" value="64.4" spread="122.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=94,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-844.9" spread="439.92"/>
                    <measurement group_id="O2" value="0.7" spread="101.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=157,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.40" spread="10.115"/>
                    <measurement group_id="O2" value="11.95" spread="12.637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=95,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-37.90" spread="12.756"/>
                    <measurement group_id="O2" value="0.70" spread="6.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=156,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="419.9" spread="257.71"/>
                    <measurement group_id="O2" value="124.6" spread="213.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=94,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-265.1" spread="168.81"/>
                    <measurement group_id="O2" value="-11.6" spread="216.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=157,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.86" spread="7.852"/>
                    <measurement group_id="O2" value="25.25" spread="14.406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=95,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="11.185"/>
                    <measurement group_id="O2" value="0.34" spread="5.150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=151,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259.7" spread="167.94"/>
                    <measurement group_id="O2" value="21.4" spread="45.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=88,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-218.9" spread="127.69"/>
                    <measurement group_id="O2" value="1.0" spread="52.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)</title>
        <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)</title>
          <description>Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.</description>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=152,213</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="213"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.97" spread="7.245"/>
                    <measurement group_id="O2" value="4.81" spread="5.294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=89,176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.86" spread="7.222"/>
                    <measurement group_id="O2" value="0.20" spread="3.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Sclerosis (MS) Relapses During Treatment</title>
        <description>A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (&lt;37.5°C) or infection.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Sclerosis (MS) Relapses During Treatment</title>
          <description>A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (&lt;37.5°C) or infection.</description>
          <population>Safety analysis set</population>
          <units>relapses</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of patients with relapses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total number of relapses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapses not requiring steroid use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Relapses requiring steroid use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment</title>
        <description>A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (&lt;37.5°C) or infection.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment</title>
          <description>A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (&lt;37.5°C) or infection.</description>
          <population>Safety analysis set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Patients with ≥ 1 relapses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Patients with relapse who received ≥ 1 steroid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Corticosteroids for systemic use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methylprednisolone sodium succinate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Methylprednisolone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prednisone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Determined Disease Steps (PDDS)</title>
        <description>PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden.</description>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Determined Disease Steps (PDDS)</title>
          <description>PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden.</description>
          <population>Safety analysis set</population>
          <units>scores</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=163,217</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="163"/>
                    <count group_id="O2" value="217"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.85"/>
                    <measurement group_id="O2" value="1.8" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 n=103,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="1.95"/>
                    <measurement group_id="O2" value="1.8" spread="2.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=103,188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.87"/>
                    <measurement group_id="O2" value="-0.0" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in T2 Lesion Burden</title>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in T2 Lesion Burden</title>
          <population>Safety analysis set</population>
          <units>number of lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=91,84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="12.74"/>
                    <measurement group_id="O2" value="9.7" spread="15.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 n=21,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5" spread="8.20"/>
                    <measurement group_id="O2" value="13.1" spread="13.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=21,17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="2.36"/>
                    <measurement group_id="O2" value="3.2" spread="12.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline for New Gd-Enhancing T1 Lesion Count</title>
        <time_frame>Baseline to Month 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline for New Gd-Enhancing T1 Lesion Count</title>
          <population>Safety analysis set</population>
          <units>number of lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=125,147</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="125"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.09"/>
                    <measurement group_id="O2" value="0.2" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12 n=33,28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="0.24"/>
                    <measurement group_id="O2" value="0.2" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=33,28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.61"/>
                    <measurement group_id="O2" value="0.2" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)</title>
        <time_frame>Baseline to Month 6 and 12</time_frame>
        <population>Safety analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)</title>
          <population>Safety analysis set</population>
          <units>cells/uL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (BL) n=159,215</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                    <count group_id="O2" value="215"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.273" spread="1.2930"/>
                    <measurement group_id="O2" value="1.391" spread="1.2600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 6 n=116,195</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="116"/>
                    <count group_id="O2" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.038" spread="0.2874"/>
                    <measurement group_id="O2" value="0.045" spread="0.4724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from BL to Month 12 n=100,180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.040" spread="0.3397"/>
                    <measurement group_id="O2" value="0.145" spread="0.6062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 18. 5 months</time_frame>
      <desc>Any sign or symptom that occurs during the study treatment plus the 30 days post treatment</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1</title>
          <description>RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2</title>
          <description>RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Histoplasmosis disseminated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Lumbar radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis relapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysfunctional uterine bleeding</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (21.0)</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="70" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharospasm</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Macular oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Central nervous system lesion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="217"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="163"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
              </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>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
      <email>Novartis.email@novartis.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/NCT03257358
org study id: CFTY720DUS40
nct id: NCT03257358
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)
      after treatment with 0.5mg fingolimod
This study used a 2-cohort, nonrandomized, open-label, multicenter design. Cohort 1: The
      first cohort was to be comprised of approximately 200 patients with RMS, who were newly
      prescribed commercially available fingolimod 0.5 mg/day. Cohort 2: The second cohort was to
      be comprised of approximately 200 RMS patients who had been on commercially available
      fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years.
      Patients from both cohorts were recruited simultaneously from up to 125 MS centers in the
      United States. Both cohorts ran concurrently. The study consisted of 2 periods: Screening (up
      to 4 weeks) and Treatment period from Baseline (end of screening period considered as Day 1)
      up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post
      treatment..
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two-cohort, non-randomized, open-label multicenter
primary purpose: Basic Science
masking: None (Open Label)
measure: Change From Baseline to Month 6 in CD4+ Naive T Cells (CCR7+ CD45RA+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD4+ Th1 Cells (CXCR3+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD4+ Th2 Cells (CCR4+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD4+ Th17 Cells (CCR6+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD8+ Naive T Cells (CCR7+CD45RA+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Naive B Lymphocytes (CD19+CD27-)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Memory B Lymphocytes (CD19+CD27+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Monocytes (CD14+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Neutrophils (CD16+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in NK Cells (CD56+)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Total CD4+ Absolute Cell Count
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Total CD4+ Differential Cell Count
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Total CD8+ Absolute Cell Count
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Total CD8+ Differential Cell Counts (%)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Total CD19+ Absolute Cell Count
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 6 in Total CD19+ Differential Cell Count (%)
time frame: Baseline to Month 6
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD4+ Naive T Cells (CCR7+CD45RA+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD4+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD4+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD4+ Th1 Cells (CXCR3+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD4+ Th2 Cells (CCR4+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD4+ Th17 Cells (CCR6+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD8+ Naive T Cells (CCR7+CD45RA+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD8+ Central Memory T Cells (CCR7+CD45RA-CD45RO+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in CD8+ Effector Memory T Cells (CCR7-CD45RA-CD45RO+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Naive B Lymphocytes (CD19+CD27-)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Memory B Lymphocytes (CD19+CD27+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Regulatory B Lymphocytes (CD19+CD24+CD38+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Monocytes (CD14+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Neutrophils (CD16+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in NK Cells (CD56+)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Total CD4+ Absolute Cell Count
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Total CD4+ Differential Cell Count (%)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Total CD8+ Absolute Cell Count
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Total CD8+ Differential Cell Counts (%)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Total CD19+ Absolute Cell Count
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Change From Baseline to Month 12 in Total CD19+ Differential Cell Count (%)
time frame: Baseline to Month 12
description: Blood samples (approximately 60-80 ml) were collected at specifiied visits for biomarker and hematology assessments. In Cohort 1 patients it was critical that the blood sample was collected prior to administration of fingolimod, first dose observation (FDO). A central laboratory was used for analysis of all specimens collected.
measure: Multiple Sclerosis (MS) Relapses During Treatment
time frame: Baseline to Month 12
description: A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection.
measure: Number of Participants Who Received Steroid Treatment for MS Relapses During Treatment
time frame: Baseline to Month 12
description: A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (<37.5°C) or infection.
measure: Change From Baseline in Patient Determined Disease Steps (PDDS)
time frame: Baseline to Month 12
description: PDDS scoring ranges 0 to 8. 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; 7 = Wheelchair/scooter; 8 = Bedridden.
measure: Change From Baseline in T2 Lesion Burden
time frame: Baseline to Month 12
measure: Change From Baseline for New Gd-Enhancing T1 Lesion Count
time frame: Baseline to Month 12
measure: Change From Baseline to Months 6 and 12 in the Anti-JCV Antibody Index (Index/Value)
time frame: Baseline to Month 6 and 12
arm group label: Cohort 1
arm group type: Other
description: RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day
arm group label: Cohort 2
arm group type: Other
description: RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years
intervention type: Drug
intervention name: Fingolimod
description: Commercially available 0.5mg hard capsules, taken orally once per day
arm group label: Cohort 1
arm group label: Cohort 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: United States
url: https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=558
description: A Plain Language Trial Summary is available on novartisclinicaltrials.com
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Fingolimod Hydrochloride
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
ipd url: https://www.clinicalstudydatarequest.com
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