<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/NCT02255656</url>
  </required_header>
  <id_info>
    <org_study_id>LPS13649</org_study_id>
    <secondary_id>2013-003884-71</secondary_id>
    <secondary_id>U1111-1148-2987</secondary_id>
    <nct_id>NCT02255656</nct_id>
  </id_info>
  <brief_title>Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409</brief_title>
  <acronym>TOPAZ</acronym>
  <official_title>A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genzyme, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</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>
      Primary Objective:&#xD;
&#xD;
      To evaluate long-term safety of alemtuzumab.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To evaluate long term efficacy of alemtuzumab.&#xD;
&#xD;
        -  To evaluate the safety profile of participants who received other Disease Modifying&#xD;
           Treatment (DMT) following alemtuzumab treatment.&#xD;
&#xD;
        -  To evaluate participant-reported Quality of Life (QoL) outcomes and health resource&#xD;
           utilization of participant who received alemtuzumab.&#xD;
&#xD;
        -  To evaluate as needed re-treatment with alemtuzumab and other DMTs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total duration per participants was up to 5.6 years.&#xD;
&#xD;
      As per Study Investigator discretion, participants can be treated with additional courses of&#xD;
      alemtuzumab or any commercialized DMTs.&#xD;
&#xD;
      All participants who completed CAMMS03409 were allowed into the study, which might include&#xD;
      specific vulnerable populations. If the investigator decided to treat a participant with a&#xD;
      course of alemtuzumab, appropriate cautionary measures were applied as indicated in the&#xD;
      approved labelling, or, in ex-European Union countries where Lemtrada was not approved,&#xD;
      according to the investigator's brochure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2015</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>From Baseline until the end of the study (up to a maximum duration of 5.6 years)</time_frame>
    <description>An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 [i.e. up to a maximum of 5.6 years]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Infusion-Associated Reactions (IAR)</measure>
    <time_frame>Within 24 hours of any alemtuzumab infusion</time_frame>
    <description>Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events of Special Interest (AESI)</measure>
    <time_frame>From Baseline until the end of the study (up to a maximum duration of 5.6 years)</time_frame>
    <description>Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Potentially Clinically Significant Laboratory Abnormalities</measure>
    <time_frame>From Baseline until the end of the study (up to a maximum duration of 5.6 years)</time_frame>
    <description>Criteria for potentially clinically significant laboratory abnormalities included:&#xD;
Hemoglobin (Hb): less than or equal to (&lt;=)115 grams per liter (g/L)(Male [M]), &lt;= 95 g/L (Female[ F]); greater than or equal to (&gt;=)185 g/L (M), &gt;= 165 g/L (F); Decrease From Baseline (DFB) &gt;= 20 g/L.&#xD;
Hematocrit: &lt;= 0.37 volume/volume (v/v) (M); &lt;= 0.32 v/v (F); &gt;= 0.55 v/v (M); &gt;= 0.5 v/v (F).&#xD;
Red Blood Cells (RBCs): &gt;=6 *10^12/L.&#xD;
Platelets: &lt;100 *10^9/L; &gt;=700 *10^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Annualized Relapse Rate</measure>
    <time_frame>Up to a maximum duration of 5.6 years</time_frame>
    <description>Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Who Were Relapse Free</measure>
    <time_frame>Up to a maximum duration of 5.6 years</time_frame>
    <description>Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60</time_frame>
    <description>EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan</measure>
    <time_frame>Up to a maximum duration of 5.6 years</time_frame>
    <description>Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan</measure>
    <time_frame>Up to a maximum duration of 5.6 years</time_frame>
    <description>Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan</measure>
    <time_frame>Up to a maximum duration of 5.6 years</time_frame>
    <description>Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>The total lesion volume (T1 lesions) was measured by MRI scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>The total lesion volume (T2 lesions) was measured by MRI scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>The brain parenchymal fraction was measured by MRI scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>The FAMS is a self-reported multidimensional index comprising a total of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Each item (except those for &quot;additional concerns&quot;) was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported &quot;Yes&quot; as an answer to &quot;employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution&quot; questions were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e.&quot;Yes&quot; as an answer to &quot;had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required&quot; questions were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for &quot;total scheduled working hours of participants; number of hours missed from work by participants due to MS&quot; were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for &quot;total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS&quot; were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis</measure>
    <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis</measure>
    <time_frame>Baseline up to end of the study (up to a maximum duration of 5.6 years)</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis</measure>
    <time_frame>Baseline up to end of the study (up to a maximum duration of 5.6 years)</time_frame>
    <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported &quot;Yes&quot; as an answer to questions related to impact on work: &quot;forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above&quot; questions were reported in this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1062</enrollment>
  <condition>Relapsing Remitting Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Alemtuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>alemtuzumab GZ402673</intervention_name>
    <description>Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous</description>
    <arm_group_label>Alemtuzumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed&#xD;
        written informed consent form.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Participant participating in another investigational interventional study.&#xD;
&#xD;
        The above information was not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 1086</name>
      <address>
        <city>Cullman</city>
        <state>Alabama</state>
        <zip>00000</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1031</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1171</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1090</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1040</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1152</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1093</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1027</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1078</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1059</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <zip>32751</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1173</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1034</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1005</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1049</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1008</name>
      <address>
        <city>Northbrook</city>
        <state>Illinois</state>
        <zip>60062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1001</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1024</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1017</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1022</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1083</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1039</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1021</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1061</name>
      <address>
        <city>Wellesley</city>
        <state>Massachusetts</state>
        <zip>02481</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1028</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1025</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105-2945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1020</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1054</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1084</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1092</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1073</name>
      <address>
        <city>Teaneck</city>
        <state>New Jersey</state>
        <zip>07666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1014</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1081</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1026</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1160</name>
      <address>
        <city>Patchogue</city>
        <state>New York</state>
        <zip>11772</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1015</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1053</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1095</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1082</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1035</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1058</name>
      <address>
        <city>Uniontown</city>
        <state>Ohio</state>
        <zip>44685</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1067</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1097</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1057</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1163</name>
      <address>
        <city>Cordova</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1055</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1009</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1042</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1018</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1002</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1046</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1037</name>
      <address>
        <city>Vienna</city>
        <state>Virginia</state>
        <zip>22182</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1068</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 03208</name>
      <address>
        <city>Caba</city>
        <zip>C1061ABD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2013</name>
      <address>
        <city>Auchenflower</city>
        <zip>4066</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2001</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2011</name>
      <address>
        <city>Hobart</city>
        <zip>7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2012</name>
      <address>
        <city>Kogarah</city>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2003</name>
      <address>
        <city>Melbourne</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2002</name>
      <address>
        <city>Parkville</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2005</name>
      <address>
        <city>Southport</city>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2009</name>
      <address>
        <city>Sydney</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 2006</name>
      <address>
        <city>Westmead</city>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5005</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5004</name>
      <address>
        <city>Esneux</city>
        <zip>4130</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5001</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3006</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90110000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3002</name>
      <address>
        <city>Recife</city>
        <zip>52010-040</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3001</name>
      <address>
        <city>São Paulo</city>
        <zip>01221-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3003</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1102</name>
      <address>
        <city>Calgary</city>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1105</name>
      <address>
        <city>Gatineau</city>
        <zip>J8Y1W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1104</name>
      <address>
        <city>Greenfield Park</city>
        <zip>J4V2J2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1109</name>
      <address>
        <city>Kingston</city>
        <zip>K7L2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1110</name>
      <address>
        <city>London</city>
        <zip>N6A5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1101</name>
      <address>
        <city>Ottawa</city>
        <zip>K1H8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1106</name>
      <address>
        <city>Vancouver</city>
        <zip>V6T1Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4803</name>
      <address>
        <city>Brno</city>
        <zip>65691</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4804</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4801</name>
      <address>
        <city>Praha 2</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4802</name>
      <address>
        <city>Teplice</city>
        <zip>41501</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5302</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5301</name>
      <address>
        <city>København Ø.</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4602</name>
      <address>
        <city>Berlin</city>
        <zip>13347</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4607</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4634</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4622</name>
      <address>
        <city>Hamburg</city>
        <zip>22307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4605</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4609</name>
      <address>
        <city>Hennigsdorf</city>
        <zip>16761</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4608</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4610</name>
      <address>
        <city>Rostock</city>
        <zip>18147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4613</name>
      <address>
        <city>Wermsdorf</city>
        <zip>04779</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5501</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 5505</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4112</name>
      <address>
        <city>Cagliari</city>
        <zip>09126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4102</name>
      <address>
        <city>Gallarate (VA)</city>
        <zip>21013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4106</name>
      <address>
        <city>Orbassano (TO)</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4110</name>
      <address>
        <city>Roma</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3105</name>
      <address>
        <city>Chihuahua</city>
        <zip>31203</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3102</name>
      <address>
        <city>Mexico</city>
        <zip>14260</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4202</name>
      <address>
        <city>Sittard-Geleen</city>
        <zip>6162BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4902</name>
      <address>
        <city>Krakow</city>
        <zip>31-505</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4901</name>
      <address>
        <city>Lodz</city>
        <zip>90-324</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4903</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4904</name>
      <address>
        <city>Poznan</city>
        <zip>60-355</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4905</name>
      <address>
        <city>Warszawa</city>
        <zip>02-957</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6009</name>
      <address>
        <city>Kazan</city>
        <zip>420097</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6001</name>
      <address>
        <city>Moscow</city>
        <zip>1217015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6005</name>
      <address>
        <city>Moscow</city>
        <zip>1217015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6003</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6006</name>
      <address>
        <city>Nizhny Novgorod</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6010</name>
      <address>
        <city>Pyatigorsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6002</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6004</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6008</name>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6013</name>
      <address>
        <city>Samara</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6016</name>
      <address>
        <city>Ufa</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4301</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4303</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4305</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4304</name>
      <address>
        <city>Sevilla</city>
        <zip>41071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4701</name>
      <address>
        <city>Göteborg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4702</name>
      <address>
        <city>Umeå</city>
        <zip>90185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6102</name>
      <address>
        <city>Kharkov</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6104</name>
      <address>
        <city>Kiev</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 6103</name>
      <address>
        <city>Lviv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4004</name>
      <address>
        <city>Bristol</city>
        <zip>BS105NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4001</name>
      <address>
        <city>Cambridge</city>
        <zip>CB50QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4005</name>
      <address>
        <city>Cardiff</city>
        <zip>CF44XN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4006</name>
      <address>
        <city>London</city>
        <zip>E12AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4008</name>
      <address>
        <city>Salford</city>
        <zip>M68HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 4007</name>
      <address>
        <city>Sheffield</city>
        <zip>S102JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>June 30, 2021</results_first_submitted>
  <results_first_submitted_qc>June 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 23, 2021</results_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alemtuzumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </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>January 28, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02255656/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>March 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02255656/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 142 study centers in 21 countries. A total of 1062 participants were screened between 7 January 2015 and 28 June 2016 and were enrolled in this current study (LPS13649 [TOPAZ]).</recruitment_details>
      <pre_assignment_details>Subgroup analysis ([Delayed Alemtuzumab Treatment[DAT] &amp; Immediate Alemtuzumab Treatment[IAT]subgroup) was performed only for outcome measures and safety analysis. Participants who rolled over from CAMMS223(NCT00050778) to CAMMS03409 (NCT00930553),then subsequently enrolled and took 24 mg alemtuzumab in CAMMS324 (NCT00548405) study, were not considered as part of DAT or IAT subgroup &amp; included in overall group only. Participant flow and Baseline analysis was performed on overall population only.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Alemtuzumab</title>
          <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1062"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="592"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="470"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor compliance to protocol</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to Coronavirus Disease (Covid-19)</title>
              <participants_list>
                <participants group_id="P1" count="300"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Alemtuzumab</title>
          <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1062"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.2" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="686"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="988"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)</title>
        <description>An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 [i.e. up to a maximum of 5.6 years]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.</description>
        <time_frame>From Baseline until the end of the study (up to a maximum duration of 5.6 years)</time_frame>
        <population>Analysis was performed on safety analysis set that included all participants who signed the informed consent form (ICF). As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the subcutaneous interferon beta-1a (SC IFNB1a) treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)</title>
          <description>An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 [i.e. up to a maximum of 5.6 years]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.</description>
          <population>Analysis was performed on safety analysis set that included all participants who signed the informed consent form (ICF). As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</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="241"/>
                <count group_id="O2" value="598"/>
                <count group_id="O3" value="1062"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204"/>
                    <measurement group_id="O2" value="500"/>
                    <measurement group_id="O3" value="879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TESAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="133"/>
                    <measurement group_id="O3" value="237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TEAE leading to permanent treatment discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Infusion-Associated Reactions (IAR)</title>
        <description>Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.</description>
        <time_frame>Within 24 hours of any alemtuzumab infusion</time_frame>
        <population>Analysis was performed on re-treated population that included all participants who had signed the ICF and who had received study drug in the current study LPS13649. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infusion-Associated Reactions (IAR)</title>
          <description>Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.</description>
          <population>Analysis was performed on re-treated population that included all participants who had signed the ICF and who had received study drug in the current study LPS13649. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</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="83"/>
                <count group_id="O2" value="164"/>
                <count group_id="O3" value="294"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="89"/>
                    <measurement group_id="O3" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events of Special Interest (AESI)</title>
        <description>Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.</description>
        <time_frame>From Baseline until the end of the study (up to a maximum duration of 5.6 years)</time_frame>
        <population>Analysis was performed on safety population. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], and CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events of Special Interest (AESI)</title>
          <description>Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.</description>
          <population>Analysis was performed on safety population. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</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="241"/>
                <count group_id="O2" value="598"/>
                <count group_id="O3" value="1062"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypersensitivity or anaphylaxis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pregnancy of a woman entered in the study</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic overdose (serious or non-serious) with IMP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Increase in ALT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Autoimmune mediated conditions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemophagocytic lymphohistiocytosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive multifocal leukoencephalopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temporally associated AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious infections</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malignancy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pneumonitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Potentially Clinically Significant Laboratory Abnormalities</title>
        <description>Criteria for potentially clinically significant laboratory abnormalities included:&#xD;
Hemoglobin (Hb): less than or equal to (&lt;=)115 grams per liter (g/L)(Male [M]), &lt;= 95 g/L (Female[ F]); greater than or equal to (&gt;=)185 g/L (M), &gt;= 165 g/L (F); Decrease From Baseline (DFB) &gt;= 20 g/L.&#xD;
Hematocrit: &lt;= 0.37 volume/volume (v/v) (M); &lt;= 0.32 v/v (F); &gt;= 0.55 v/v (M); &gt;= 0.5 v/v (F).&#xD;
Red Blood Cells (RBCs): &gt;=6 *10^12/L.&#xD;
Platelets: &lt;100 *10^9/L; &gt;=700 *10^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</description>
        <time_frame>From Baseline until the end of the study (up to a maximum duration of 5.6 years)</time_frame>
        <population>Analysis was performed on all participants who had signed the ICF; and received study drug in the TOPAZ study; or in studies CAMMS223,CAMMS323,CAMMS324 or CAMMS03409, and did not complete 48 months of follow-up at the screening visit in the TOPAZ study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab (Overall)</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Potentially Clinically Significant Laboratory Abnormalities</title>
          <description>Criteria for potentially clinically significant laboratory abnormalities included:&#xD;
Hemoglobin (Hb): less than or equal to (&lt;=)115 grams per liter (g/L)(Male [M]), &lt;= 95 g/L (Female[ F]); greater than or equal to (&gt;=)185 g/L (M), &gt;= 165 g/L (F); Decrease From Baseline (DFB) &gt;= 20 g/L.&#xD;
Hematocrit: &lt;= 0.37 volume/volume (v/v) (M); &lt;= 0.32 v/v (F); &gt;= 0.55 v/v (M); &gt;= 0.5 v/v (F).&#xD;
Red Blood Cells (RBCs): &gt;=6 *10^12/L.&#xD;
Platelets: &lt;100 *10^9/L; &gt;=700 *10^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</description>
          <population>Analysis was performed on all participants who had signed the ICF; and received study drug in the TOPAZ study; or in studies CAMMS223,CAMMS323,CAMMS324 or CAMMS03409, and did not complete 48 months of follow-up at the screening visit in the TOPAZ study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category.</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="214"/>
                <count group_id="O2" value="316"/>
                <count group_id="O3" value="619"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hb:&lt;=115 g/L, &lt;=95 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="316"/>
                    <count group_id="O3" value="619"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hb: &gt;=185 g/L, &gt;=165 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="316"/>
                    <count group_id="O3" value="619"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hb: DFB &gt;=20 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="206"/>
                    <count group_id="O2" value="293"/>
                    <count group_id="O3" value="580"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit: &lt;= 0.37 v/v; &lt;=0.32 v/v</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="315"/>
                    <count group_id="O3" value="617"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit: &gt;=0.55 v/v; &gt;=0.5 v/v</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="213"/>
                    <count group_id="O2" value="315"/>
                    <count group_id="O3" value="617"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RBCs: &gt;=6 *10^12/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="315"/>
                    <count group_id="O3" value="618"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets: &lt;100 *10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="314"/>
                    <count group_id="O3" value="615"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets: &gt;=700 *10^9/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="314"/>
                    <count group_id="O3" value="615"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Relapse Rate</title>
        <description>Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.</description>
        <time_frame>Up to a maximum duration of 5.6 years</time_frame>
        <population>Analysis was performed on efficacy population which included all enrolled participants who had received study drug in studies CAMMS223, CAMMS323, CAMMS324 or CAMMS03409. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Relapse Rate</title>
          <description>Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.</description>
          <population>Analysis was performed on efficacy population which included all enrolled participants who had received study drug in studies CAMMS223, CAMMS323, CAMMS324 or CAMMS03409. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>relapses per participant per year</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1994" lower_limit="0.1710" upper_limit="0.2325"/>
                    <measurement group_id="O2" value="0.1608" lower_limit="0.1418" upper_limit="0.1823"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Who Were Relapse Free</title>
        <description>Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.</description>
        <time_frame>Up to a maximum duration of 5.6 years</time_frame>
        <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Who Were Relapse Free</title>
          <description>Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.</description>
          <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>proportion of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.59" lower_limit="23.73" upper_limit="35.65"/>
                    <measurement group_id="O2" value="36.86" lower_limit="32.96" upper_limit="40.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60</title>
        <description>EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60</title>
          <description>EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.</description>
          <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                    <count group_id="O2" value="583"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="0.092"/>
                    <measurement group_id="O2" value="0.03" spread="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="580"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="0.093"/>
                    <measurement group_id="O2" value="0.08" spread="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="562"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.096"/>
                    <measurement group_id="O2" value="0.10" spread="0.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="559"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.102"/>
                    <measurement group_id="O2" value="0.15" spread="0.070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="225"/>
                    <count group_id="O2" value="547"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.102"/>
                    <measurement group_id="O2" value="0.16" spread="0.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="219"/>
                    <count group_id="O2" value="545"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.103"/>
                    <measurement group_id="O2" value="0.18" spread="0.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 42</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="515"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.37" spread="0.103"/>
                    <measurement group_id="O2" value="0.24" spread="0.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="204"/>
                    <count group_id="O2" value="468"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="0.104"/>
                    <measurement group_id="O2" value="0.27" spread="0.072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 54</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="346"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="0.106"/>
                    <measurement group_id="O2" value="0.30" spread="0.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.43" spread="0.129"/>
                    <measurement group_id="O2" value="0.32" spread="0.088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan</title>
        <description>Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.</description>
        <time_frame>Up to a maximum duration of 5.6 years</time_frame>
        <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan</title>
          <description>Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.</description>
          <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>lesions per scan</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.307" lower_limit="0.880" upper_limit="1.941"/>
                    <measurement group_id="O2" value="1.558" lower_limit="1.153" upper_limit="2.105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan</title>
        <description>Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.</description>
        <time_frame>Up to a maximum duration of 5.6 years</time_frame>
        <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan</title>
          <description>Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.</description>
          <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>lesions per scan</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.033" lower_limit="6.001" upper_limit="10.753"/>
                    <measurement group_id="O2" value="9.564" lower_limit="7.656" upper_limit="11.946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan</title>
        <description>Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.</description>
        <time_frame>Up to a maximum duration of 5.6 years</time_frame>
        <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan</title>
          <description>Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.</description>
          <population>Analysis was performed on efficacy population. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>lesions per scan</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.719" lower_limit="1.141" upper_limit="2.589"/>
                    <measurement group_id="O2" value="1.908" lower_limit="1.386" upper_limit="2.628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60</title>
        <description>The total lesion volume (T1 lesions) was measured by MRI scan.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was preformed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60</title>
          <description>The total lesion volume (T1 lesions) was measured by MRI scan.</description>
          <population>Analysis was preformed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="501"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.71" spread="449.79"/>
                    <measurement group_id="O2" value="64.73" spread="241.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="489"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.73" spread="398.65"/>
                    <measurement group_id="O2" value="67.48" spread="262.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="478"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.57" spread="404.35"/>
                    <measurement group_id="O2" value="104.41" spread="524.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="421"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163.30" spread="461.38"/>
                    <measurement group_id="O2" value="76.90" spread="312.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="60"/>
                    <count group_id="O2" value="116"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="202.47" spread="499.46"/>
                    <measurement group_id="O2" value="93.61" spread="260.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60</title>
        <description>The total lesion volume (T2 lesions) was measured by MRI scan.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60</title>
          <description>The total lesion volume (T2 lesions) was measured by MRI scan.</description>
          <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="558"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.44" spread="132.04"/>
                    <measurement group_id="O2" value="9.09" spread="62.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="224"/>
                    <count group_id="O2" value="542"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.53" spread="76.73"/>
                    <measurement group_id="O2" value="13.89" spread="62.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="529"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.24" spread="94.85"/>
                    <measurement group_id="O2" value="22.02" spread="111.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="204"/>
                    <count group_id="O2" value="462"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.98" spread="80.06"/>
                    <measurement group_id="O2" value="19.46" spread="70.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="67"/>
                    <count group_id="O2" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.03" spread="136.68"/>
                    <measurement group_id="O2" value="17.95" spread="75.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60</title>
        <description>The brain parenchymal fraction was measured by MRI scan.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60</title>
          <description>The brain parenchymal fraction was measured by MRI scan.</description>
          <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="221"/>
                    <count group_id="O2" value="549"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="1.59"/>
                    <measurement group_id="O2" value="-1.49" spread="1.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="220"/>
                    <count group_id="O2" value="534"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.77" spread="1.56"/>
                    <measurement group_id="O2" value="-1.68" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="215"/>
                    <count group_id="O2" value="524"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.92" spread="1.56"/>
                    <measurement group_id="O2" value="-1.84" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="459"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="1.58"/>
                    <measurement group_id="O2" value="-2.07" spread="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.11" spread="1.67"/>
                    <measurement group_id="O2" value="-2.37" spread="1.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60</title>
        <description>The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60</title>
          <description>The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL.</description>
          <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PCS: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="228"/>
                    <count group_id="O2" value="559"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="9.38"/>
                    <measurement group_id="O2" value="0.88" spread="8.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="545"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.20" spread="9.25"/>
                    <measurement group_id="O2" value="0.59" spread="9.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="534"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="9.88"/>
                    <measurement group_id="O2" value="1.12" spread="9.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="466"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.52" spread="10.15"/>
                    <measurement group_id="O2" value="0.68" spread="9.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PCS: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="8.85"/>
                    <measurement group_id="O2" value="1.28" spread="8.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="228"/>
                    <count group_id="O2" value="559"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.21" spread="12.29"/>
                    <measurement group_id="O2" value="0.89" spread="11.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="545"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="12.23"/>
                    <measurement group_id="O2" value="1.11" spread="11.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="534"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.55" spread="12.23"/>
                    <measurement group_id="O2" value="0.94" spread="11.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="466"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="12.93"/>
                    <measurement group_id="O2" value="0.35" spread="12.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MCS: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="14.01"/>
                    <measurement group_id="O2" value="0.45" spread="11.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60</title>
        <description>The FAMS is a self-reported multidimensional index comprising a total of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Each item (except those for &quot;additional concerns&quot;) was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60</title>
          <description>The FAMS is a self-reported multidimensional index comprising a total of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Each item (except those for &quot;additional concerns&quot;) was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.</description>
          <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="230"/>
                    <count group_id="O2" value="573"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" spread="29.68"/>
                    <measurement group_id="O2" value="2.83" spread="27.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="222"/>
                    <count group_id="O2" value="551"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.45" spread="30.30"/>
                    <measurement group_id="O2" value="2.73" spread="28.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="214"/>
                    <count group_id="O2" value="532"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="30.52"/>
                    <measurement group_id="O2" value="2.70" spread="28.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="472"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.73" spread="31.46"/>
                    <measurement group_id="O2" value="1.16" spread="29.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="31.25"/>
                    <measurement group_id="O2" value="2.74" spread="26.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60</title>
        <description>The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60</title>
          <description>The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.</description>
          <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="571"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.26"/>
                    <measurement group_id="O2" value="-0.01" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="225"/>
                    <count group_id="O2" value="550"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.28"/>
                    <measurement group_id="O2" value="-0.01" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="218"/>
                    <count group_id="O2" value="530"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.27"/>
                    <measurement group_id="O2" value="-0.00" spread="0.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="469"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.27"/>
                    <measurement group_id="O2" value="-0.03" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.29"/>
                    <measurement group_id="O2" value="-0.03" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60</title>
        <description>EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60</title>
          <description>EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome.</description>
          <population>Analysis was performed on efficacy population. Here, 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done only on the 2 subgroups (DAT and IAT).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="598"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="232"/>
                    <count group_id="O2" value="560"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.09" spread="25.11"/>
                    <measurement group_id="O2" value="-1.05" spread="24.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="225"/>
                    <count group_id="O2" value="545"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.57" spread="26.69"/>
                    <measurement group_id="O2" value="-0.39" spread="21.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="527"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="22.61"/>
                    <measurement group_id="O2" value="1.42" spread="20.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="199"/>
                    <count group_id="O2" value="466"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.08" spread="23.66"/>
                    <measurement group_id="O2" value="-0.85" spread="23.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.26" spread="27.04"/>
                    <measurement group_id="O2" value="-0.77" spread="26.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported &quot;Yes&quot; as an answer to &quot;employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution&quot; questions were reported in this outcome measure.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported &quot;Yes&quot; as an answer to &quot;employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution&quot; questions were reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</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="231"/>
                <count group_id="O2" value="573"/>
                <count group_id="O3" value="1020"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Employment situation change: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="224"/>
                    <count group_id="O3" value="381"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Employment situation change: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="230"/>
                    <count group_id="O2" value="573"/>
                    <count group_id="O3" value="1014"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Employment situation change: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="220"/>
                    <count group_id="O2" value="537"/>
                    <count group_id="O3" value="960"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Employment situation change: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="518"/>
                    <count group_id="O3" value="929"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Employment situation change: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="200"/>
                    <count group_id="O2" value="467"/>
                    <count group_id="O3" value="850"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Employment situation change: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="182"/>
                    <count group_id="O3" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had sick leaves: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="157"/>
                    <count group_id="O3" value="265"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had sick leaves: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="373"/>
                    <count group_id="O3" value="642"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had sick leaves: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="148"/>
                    <count group_id="O2" value="360"/>
                    <count group_id="O3" value="645"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had sick leaves: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="324"/>
                    <count group_id="O3" value="584"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had sick leaves: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="307"/>
                    <count group_id="O3" value="565"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had sick leaves: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="56"/>
                    <count group_id="O2" value="127"/>
                    <count group_id="O3" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had hospital admission: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="203"/>
                    <count group_id="O3" value="337"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had hospital admission: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="570"/>
                    <count group_id="O3" value="1018"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="59"/>
                    <measurement group_id="O3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had hospital admission: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="544"/>
                    <count group_id="O3" value="974"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had hospital admission: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="218"/>
                    <count group_id="O2" value="522"/>
                    <count group_id="O3" value="938"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had hospital admission: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="471"/>
                    <count group_id="O3" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had hospital admission: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="184"/>
                    <count group_id="O3" value="374"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in rehabilitation center: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="74"/>
                    <count group_id="O2" value="200"/>
                    <count group_id="O3" value="334"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in rehabilitation center: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="230"/>
                    <count group_id="O2" value="573"/>
                    <count group_id="O3" value="1020"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in rehabilitation center: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="540"/>
                    <count group_id="O3" value="968"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in rehabilitation center: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="532"/>
                    <count group_id="O3" value="946"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in rehabilitation center: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="474"/>
                    <count group_id="O3" value="864"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in rehabilitation center: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="184"/>
                    <count group_id="O3" value="374"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in a nursing home: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="73"/>
                    <count group_id="O2" value="198"/>
                    <count group_id="O3" value="332"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in a nursing home: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="572"/>
                    <count group_id="O3" value="1019"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in a nursing home: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="222"/>
                    <count group_id="O2" value="545"/>
                    <count group_id="O3" value="972"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in a nursing home: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="218"/>
                    <count group_id="O2" value="523"/>
                    <count group_id="O3" value="938"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in a nursing home: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="202"/>
                    <count group_id="O2" value="472"/>
                    <count group_id="O3" value="860"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had spent time in a nursing home: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="184"/>
                    <count group_id="O3" value="369"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e.&quot;Yes&quot; as an answer to &quot;had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required&quot; questions were reported in this outcome measure.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e.&quot;Yes&quot; as an answer to &quot;had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required&quot; questions were reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</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="231"/>
                <count group_id="O2" value="573"/>
                <count group_id="O3" value="1020"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Had made changes to your house, apartment, car: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="202"/>
                    <count group_id="O3" value="339"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had made changes to your house, apartment, car: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="231"/>
                    <count group_id="O2" value="571"/>
                    <count group_id="O3" value="1020"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had made changes to your house, apartment, car: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="222"/>
                    <count group_id="O2" value="544"/>
                    <count group_id="O3" value="972"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had made changes to your house, apartment, car: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="219"/>
                    <count group_id="O2" value="527"/>
                    <count group_id="O3" value="944"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had made changes to your house, apartment, car: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="472"/>
                    <count group_id="O3" value="859"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had made changes to your house, apartment, car: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="185"/>
                    <count group_id="O3" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required assistance: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="201"/>
                    <count group_id="O3" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required assistance: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                    <count group_id="O2" value="573"/>
                    <count group_id="O3" value="1015"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required assistance: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="221"/>
                    <count group_id="O2" value="535"/>
                    <count group_id="O3" value="962"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required assistance: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="522"/>
                    <count group_id="O3" value="937"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required assistance: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="466"/>
                    <count group_id="O3" value="852"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required assistance: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="369"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required other assistance: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="202"/>
                    <count group_id="O3" value="335"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required other assistance: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="572"/>
                    <count group_id="O3" value="1011"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="144"/>
                    <measurement group_id="O3" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required other assistance: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="222"/>
                    <count group_id="O2" value="530"/>
                    <count group_id="O3" value="958"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="135"/>
                    <measurement group_id="O3" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required other assistance: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="217"/>
                    <count group_id="O2" value="523"/>
                    <count group_id="O3" value="936"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="119"/>
                    <measurement group_id="O3" value="215"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required other assistance: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="201"/>
                    <count group_id="O2" value="463"/>
                    <count group_id="O3" value="848"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="119"/>
                    <measurement group_id="O3" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Had required other assistance: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="180"/>
                    <count group_id="O3" value="367"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</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="234"/>
                <count group_id="O2" value="575"/>
                <count group_id="O3" value="1025"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Full time: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="575"/>
                    <count group_id="O3" value="1025"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="297"/>
                    <measurement group_id="O3" value="528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part time: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="575"/>
                    <count group_id="O3" value="1025"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not employed: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="234"/>
                    <count group_id="O2" value="575"/>
                    <count group_id="O3" value="1025"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="224"/>
                    <measurement group_id="O3" value="399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Full time: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="569"/>
                    <count group_id="O3" value="1013"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="291"/>
                    <measurement group_id="O3" value="511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part time: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="569"/>
                    <count group_id="O3" value="1013"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not employed: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="229"/>
                    <count group_id="O2" value="569"/>
                    <count group_id="O3" value="1013"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="225"/>
                    <measurement group_id="O3" value="398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Full time: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="549"/>
                    <count group_id="O3" value="980"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                    <measurement group_id="O2" value="273"/>
                    <measurement group_id="O3" value="488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part time: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="549"/>
                    <count group_id="O3" value="980"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not employed: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="223"/>
                    <count group_id="O2" value="549"/>
                    <count group_id="O3" value="980"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="210"/>
                    <measurement group_id="O3" value="375"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Full time: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="530"/>
                    <count group_id="O3" value="943"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="273"/>
                    <measurement group_id="O3" value="478"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part time: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="530"/>
                    <count group_id="O3" value="943"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not employed: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="216"/>
                    <count group_id="O2" value="530"/>
                    <count group_id="O3" value="943"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="200"/>
                    <measurement group_id="O3" value="357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Full time: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="204"/>
                    <count group_id="O2" value="469"/>
                    <count group_id="O3" value="860"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="225"/>
                    <measurement group_id="O3" value="424"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part time: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="204"/>
                    <count group_id="O2" value="469"/>
                    <count group_id="O3" value="860"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not employed: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="204"/>
                    <count group_id="O2" value="469"/>
                    <count group_id="O3" value="860"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="187"/>
                    <measurement group_id="O3" value="333"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Full time: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="374"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="97"/>
                    <measurement group_id="O3" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Part time: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="374"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not employed: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="183"/>
                    <count group_id="O3" value="374"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="68"/>
                    <measurement group_id="O3" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for &quot;total scheduled working hours of participants; number of hours missed from work by participants due to MS&quot; were reported in this outcome measure.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for &quot;total scheduled working hours of participants; number of hours missed from work by participants due to MS&quot; were reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
                <count group_id="O2" value="380"/>
                <count group_id="O3" value="675"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total scheduled working hours: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="153"/>
                    <count group_id="O2" value="374"/>
                    <count group_id="O3" value="660"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" spread="14.6"/>
                    <measurement group_id="O2" value="32.2" spread="16.1"/>
                    <measurement group_id="O3" value="32.9" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled working hours: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                    <count group_id="O2" value="380"/>
                    <count group_id="O3" value="675"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.6" spread="15.4"/>
                    <measurement group_id="O2" value="32.3" spread="16.6"/>
                    <measurement group_id="O3" value="32.5" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled working hours: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="367"/>
                    <count group_id="O3" value="647"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.2" spread="15.5"/>
                    <measurement group_id="O2" value="30.8" spread="16.1"/>
                    <measurement group_id="O3" value="31.6" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled working hours: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="343"/>
                    <count group_id="O3" value="615"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.6" spread="16.4"/>
                    <measurement group_id="O2" value="33.1" spread="15.1"/>
                    <measurement group_id="O3" value="33.3" spread="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled working hours: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="302"/>
                    <count group_id="O3" value="559"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4" spread="19.7"/>
                    <measurement group_id="O2" value="31.3" spread="16.3"/>
                    <measurement group_id="O3" value="32.9" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled working hours: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="124"/>
                    <count group_id="O3" value="249"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" spread="18.9"/>
                    <measurement group_id="O2" value="31.1" spread="15.8"/>
                    <measurement group_id="O3" value="31.1" spread="16.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from work: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="12.1"/>
                    <measurement group_id="O2" value="15.2" spread="15.0"/>
                    <measurement group_id="O3" value="11.7" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from work: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="3.6"/>
                    <measurement group_id="O2" value="10.1" spread="12.2"/>
                    <measurement group_id="O3" value="9.0" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from work: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="6.1"/>
                    <measurement group_id="O2" value="10.6" spread="11.3"/>
                    <measurement group_id="O3" value="10.4" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from work: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" spread="5.9"/>
                    <measurement group_id="O2" value="24.7" spread="65.4"/>
                    <measurement group_id="O3" value="18.7" spread="50.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from work: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="42"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" spread="23.1"/>
                    <measurement group_id="O2" value="37.7" spread="107.6"/>
                    <measurement group_id="O3" value="28.0" spread="77.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from work: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" spread="13.4"/>
                    <measurement group_id="O2" value="13.4" spread="13.4"/>
                    <measurement group_id="O3" value="13.9" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab (Overall)</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
          <units>percentage impact on work output</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="351"/>
                <count group_id="O3" value="622"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="349"/>
                    <count group_id="O3" value="622"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="14.4"/>
                    <measurement group_id="O2" value="10.2" spread="22.3"/>
                    <measurement group_id="O3" value="8.5" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="138"/>
                    <count group_id="O2" value="351"/>
                    <count group_id="O3" value="622"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="18.0"/>
                    <measurement group_id="O2" value="9.5" spread="21.5"/>
                    <measurement group_id="O3" value="9.0" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="137"/>
                    <count group_id="O2" value="335"/>
                    <count group_id="O3" value="596"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="20.4"/>
                    <measurement group_id="O2" value="9.4" spread="21.2"/>
                    <measurement group_id="O3" value="9.8" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="316"/>
                    <count group_id="O3" value="571"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="20.0"/>
                    <measurement group_id="O2" value="9.9" spread="21.3"/>
                    <measurement group_id="O3" value="9.4" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="279"/>
                    <count group_id="O3" value="525"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" spread="25.4"/>
                    <measurement group_id="O2" value="9.3" spread="21.7"/>
                    <measurement group_id="O3" value="9.7" spread="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="43"/>
                    <count group_id="O2" value="115"/>
                    <count group_id="O3" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="22.3"/>
                    <measurement group_id="O2" value="8.1" spread="18.9"/>
                    <measurement group_id="O3" value="9.2" spread="19.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for &quot;total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS&quot; were reported in this outcome measure.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population.Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for &quot;total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS&quot; were reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population.Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="228"/>
                <count group_id="O2" value="562"/>
                <count group_id="O3" value="1004"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total scheduled household chores hours: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="228"/>
                    <count group_id="O2" value="558"/>
                    <count group_id="O3" value="993"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="8.3"/>
                    <measurement group_id="O2" value="11.0" spread="11.0"/>
                    <measurement group_id="O3" value="10.8" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled household chores hours: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="226"/>
                    <count group_id="O2" value="562"/>
                    <count group_id="O3" value="1004"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="10.1"/>
                    <measurement group_id="O2" value="11.1" spread="11.7"/>
                    <measurement group_id="O3" value="10.9" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled household chores hours: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="219"/>
                    <count group_id="O2" value="538"/>
                    <count group_id="O3" value="954"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="11.6"/>
                    <measurement group_id="O2" value="10.9" spread="11.4"/>
                    <measurement group_id="O3" value="10.6" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled household chores hours: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="505"/>
                    <count group_id="O3" value="899"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" spread="10.2"/>
                    <measurement group_id="O2" value="11.7" spread="13.1"/>
                    <measurement group_id="O3" value="11.0" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled household chores hours: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="452"/>
                    <count group_id="O3" value="825"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="8.9"/>
                    <measurement group_id="O2" value="10.5" spread="10.6"/>
                    <measurement group_id="O3" value="10.3" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total scheduled household chores hours: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="178"/>
                    <count group_id="O3" value="363"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" spread="8.7"/>
                    <measurement group_id="O2" value="11.2" spread="11.1"/>
                    <measurement group_id="O3" value="11.5" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from household chores: Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="3.3"/>
                    <measurement group_id="O2" value="6.5" spread="6.9"/>
                    <measurement group_id="O3" value="6.0" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from household chores: Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="47"/>
                    <count group_id="O2" value="90"/>
                    <count group_id="O3" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="3.5"/>
                    <measurement group_id="O2" value="6.8" spread="7.7"/>
                    <measurement group_id="O3" value="6.2" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from household chores: Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="104"/>
                    <count group_id="O3" value="181"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="9.0"/>
                    <measurement group_id="O2" value="7.1" spread="10.6"/>
                    <measurement group_id="O3" value="6.6" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from household chores: Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="7.4"/>
                    <measurement group_id="O2" value="7.7" spread="14.2"/>
                    <measurement group_id="O3" value="7.0" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from household chores: Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="74"/>
                    <count group_id="O3" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="4.3"/>
                    <measurement group_id="O2" value="6.2" spread="10.6"/>
                    <measurement group_id="O3" value="5.7" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of hours missed from household chores: Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="5.2"/>
                    <measurement group_id="O2" value="5.8" spread="5.1"/>
                    <measurement group_id="O3" value="5.9" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.</description>
        <time_frame>Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
          <units>percentage impact on work output</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="212"/>
                <count group_id="O2" value="531"/>
                <count group_id="O3" value="947"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="212"/>
                    <count group_id="O2" value="531"/>
                    <count group_id="O3" value="947"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" spread="23.8"/>
                    <measurement group_id="O2" value="16.4" spread="26.0"/>
                    <measurement group_id="O3" value="16.8" spread="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                    <count group_id="O2" value="524"/>
                    <count group_id="O3" value="931"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" spread="27.3"/>
                    <measurement group_id="O2" value="16.6" spread="26.6"/>
                    <measurement group_id="O3" value="17.7" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="197"/>
                    <count group_id="O2" value="501"/>
                    <count group_id="O3" value="886"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" spread="28.5"/>
                    <measurement group_id="O2" value="18.5" spread="27.4"/>
                    <measurement group_id="O3" value="19.4" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="183"/>
                    <count group_id="O2" value="453"/>
                    <count group_id="O3" value="813"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.5" spread="25.9"/>
                    <measurement group_id="O2" value="16.5" spread="26.2"/>
                    <measurement group_id="O3" value="17.6" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                    <count group_id="O2" value="415"/>
                    <count group_id="O3" value="769"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" spread="28.8"/>
                    <measurement group_id="O2" value="17.0" spread="26.8"/>
                    <measurement group_id="O3" value="18.6" spread="27.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="170"/>
                    <count group_id="O3" value="344"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" spread="28.3"/>
                    <measurement group_id="O2" value="13.1" spread="22.9"/>
                    <measurement group_id="O3" value="14.8" spread="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.</description>
        <time_frame>Baseline up to end of the study (up to a maximum duration of 5.6 years)</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="228"/>
                <count group_id="O2" value="559"/>
                <count group_id="O3" value="997"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="4.0"/>
                    <measurement group_id="O2" value="10.2" spread="5.0"/>
                    <measurement group_id="O3" value="10.5" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis</title>
        <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported &quot;Yes&quot; as an answer to questions related to impact on work: &quot;forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above&quot; questions were reported in this outcome measure.</description>
        <time_frame>Baseline up to end of the study (up to a maximum duration of 5.6 years)</time_frame>
        <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</population>
        <group_list>
          <group group_id="O1">
            <title>Delayed Alemtuzumab Treatment (DAT)</title>
            <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O2">
            <title>Initial Alemtuzumab Treatment (IAT)</title>
            <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
          <group group_id="O3">
            <title>Alemtuzumab</title>
            <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
          </group>
        </group_list>
        <measure>
          <title>HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis</title>
          <description>Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported &quot;Yes&quot; as an answer to questions related to impact on work: &quot;forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above&quot; questions were reported in this outcome measure.</description>
          <population>Analysis was performed on efficacy population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure and 'Number analyzed' = participants with available data for each specified category. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).</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="164"/>
                <count group_id="O2" value="399"/>
                <count group_id="O3" value="709"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>My MS or treatments forced me to work part-time when I wanted to work full-time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="81"/>
                    <count group_id="O3" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="81"/>
                    <measurement group_id="O3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My MS or treatments kept me from having a job when I wanted to work full-time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="88"/>
                    <count group_id="O3" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="88"/>
                    <measurement group_id="O3" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>My MS or treatments kept me from having a job when I wanted to work part-time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="42"/>
                    <count group_id="O3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None of the above</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="164"/>
                    <count group_id="O2" value="399"/>
                    <count group_id="O3" value="709"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164"/>
                    <measurement group_id="O2" value="399"/>
                    <measurement group_id="O3" value="709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All Adverse Events were collected from the Baseline until the end of the study (up to a maximum duration of 5.6 years).</time_frame>
      <desc>Reported adverse events and death were TEAEs that is AEs that developed/worsened during the 'treatment period' (time from Baseline until the end of the study). Analysis was performed on safety population. As pre-specified, safety analysis was done on the overall population along with 2 subgroups (DAT and IAT).</desc>
      <group_list>
        <group group_id="E1">
          <title>Delayed Alemtuzumab Treatment (DAT)</title>
          <description>Participants from the SC IFNB1a treatment arms of studies CAMMS323 and CAMMS324, who received their initial 2 treatment courses of alemtuzumab during the CAMMS03409 extension study were included in the DAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
        </group>
        <group group_id="E2">
          <title>Initial Alemtuzumab Treatment (IAT)</title>
          <description>Participants from the 12 mg/day alemtuzumab treatment arms of the studies CAMMS323 and CAMMS324 (who were subsequently enrolled in CAMMS03409 extension study and then entered in this study LPS13649) were included in the IAT subgroup of the current study (LPS13649). Participants received alemtuzumab intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
        </group>
        <group group_id="E3">
          <title>Alemtuzumab</title>
          <description>All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 mg/day for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</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="241"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="598"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="133" subjects_at_risk="598"/>
                <counts group_id="E3" subjects_affected="237" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Immune Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Left Ventricular Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Bundle Branch Block Left</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Left Ventricular Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Ventricular Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Septal Defect</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Congenital Cystic Kidney Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Congenital Nail Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Foetal Chromosome Abnormality</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Trisomy 21</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Haematotympanum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Autoimmune Thyroid Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Autoimmune Thyroiditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Basedow's Disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="598"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Thyroid Dermatopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Endocrine Ophthalmopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Exophthalmos</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Eyelid Ptosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Optic Ischaemic Neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Periorbital Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Colitis Ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer Perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Intestinal Ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Obstructive Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pancreatitis Chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter Site Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Complication Associated With Device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Drug Intolerance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Sudden Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Immune Reconstitution Inflammatory Syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Abscess Rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Bacterial Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="7" subjects_affected="3" subjects_at_risk="598"/>
                <counts group_id="E3" events="8" subjects_affected="4" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Cellulitis Staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Escherichia Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Bacterial Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Herpes Zoster Infection Neurological</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Infected Bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Infected Lymphocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Klebsiella Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Localised Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Neonatal Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Osteomyelitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="598"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pneumonia Bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pneumonia Streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Scrotal Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="598"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="598"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection Bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Uterine Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Brain Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Burns Third Degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Craniocerebral Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Face Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Foot Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Head Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Induced Abortion Failed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Intentional Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Meniscus Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Post Procedural Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Skull Fractured Base</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Tibia Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Traumatic Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Ulna Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Upper Limb Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Wrist Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Antiphospholipid Antibodies Positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Human Papilloma Virus Test Positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Diabetic Ketosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Electrolyte Imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Type 1 Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="598"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Joint Contracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Systemic Lupus Erythematosus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Brenner Tumour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Cervix Carcinoma Stage 0</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Cutaneous T-Cell Lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Gallbladder Cancer Stage Iii</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Intraductal Proliferative Breast Lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Invasive Ductal Breast Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Invasive Lobular Breast Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Laryngeal Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Lung Squamous Cell Carcinoma Stage Iii</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma In Situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Malignant Neoplasm Of Unknown Primary Site</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Neuroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Ovarian Adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Ovarian Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Ovarian Germ Cell Teratoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Rectal Cancer Metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma Of Skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Uterine Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Uterine Leiomyoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="598"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Generalised Tonic-Clonic Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Limbic Encephalitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Loss Of Consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Lumbosacral Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Multiple Sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Multiple Sclerosis Relapse</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="241"/>
                <counts group_id="E2" events="30" subjects_affected="18" subjects_at_risk="598"/>
                <counts group_id="E3" events="43" subjects_affected="30" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Optic Neuritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Partial Seizures</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Post Herpetic Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Postural Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Resting Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Toxic Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Trigeminal Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Uhthoff's Phenomenon</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="598"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion Missed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Abortion Spontaneous</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="241"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="598"/>
                <counts group_id="E3" events="15" subjects_affected="11" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Anembryonic Gestation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Ectopic Pregnancy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Foetal Distress Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Hellp Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Missed Labour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pre-Eclampsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="598"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Prolonged Labour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcoholism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Behaviour Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Completed Suicide</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Depression Suicidal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Drug Abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Major Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Mental Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Substance-Induced Psychotic Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Cystitis Haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Lupus Nephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Renal Colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Renal Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical Dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="598"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Cystocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Female Genital Tract Fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Uterine Polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Vaginal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Nasal Septum Deviation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Organising Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Pulmonary Fibrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="598"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="598"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="150" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="338" subjects_at_risk="598"/>
                <counts group_id="E3" subjects_affected="601" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="241"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="598"/>
                <counts group_id="E3" events="37" subjects_affected="37" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="241"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="598"/>
                <counts group_id="E3" events="45" subjects_affected="43" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="241"/>
                <counts group_id="E2" events="54" subjects_affected="44" subjects_at_risk="598"/>
                <counts group_id="E3" events="81" subjects_affected="67" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="241"/>
                <counts group_id="E2" events="35" subjects_affected="29" subjects_at_risk="598"/>
                <counts group_id="E3" events="57" subjects_affected="50" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="241"/>
                <counts group_id="E2" events="28" subjects_affected="25" subjects_at_risk="598"/>
                <counts group_id="E3" events="55" subjects_affected="48" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="60" subjects_affected="34" subjects_at_risk="241"/>
                <counts group_id="E2" events="112" subjects_affected="73" subjects_at_risk="598"/>
                <counts group_id="E3" events="204" subjects_affected="129" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="241"/>
                <counts group_id="E2" events="45" subjects_affected="34" subjects_at_risk="598"/>
                <counts group_id="E3" events="71" subjects_affected="57" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="241"/>
                <counts group_id="E2" events="73" subjects_affected="50" subjects_at_risk="598"/>
                <counts group_id="E3" events="123" subjects_affected="96" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="56" subjects_affected="37" subjects_at_risk="241"/>
                <counts group_id="E2" events="143" subjects_affected="78" subjects_at_risk="598"/>
                <counts group_id="E3" events="271" subjects_affected="151" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="241"/>
                <counts group_id="E2" events="34" subjects_affected="27" subjects_at_risk="598"/>
                <counts group_id="E3" events="74" subjects_affected="54" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="19" subjects_at_risk="241"/>
                <counts group_id="E2" events="45" subjects_affected="39" subjects_at_risk="598"/>
                <counts group_id="E3" events="86" subjects_affected="69" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="241"/>
                <counts group_id="E2" events="34" subjects_affected="30" subjects_at_risk="598"/>
                <counts group_id="E3" events="68" subjects_affected="62" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="52" subjects_affected="37" subjects_at_risk="241"/>
                <counts group_id="E2" events="87" subjects_affected="67" subjects_at_risk="598"/>
                <counts group_id="E3" events="164" subjects_affected="125" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="23" subjects_affected="14" subjects_at_risk="241"/>
                <counts group_id="E2" events="46" subjects_affected="39" subjects_at_risk="598"/>
                <counts group_id="E3" events="86" subjects_affected="63" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="241"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="598"/>
                <counts group_id="E3" events="45" subjects_affected="43" subjects_at_risk="1062"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="241"/>
                <counts group_id="E2" events="32" subjects_affected="29" subjects_at_risk="598"/>
                <counts group_id="E3" events="62" subjects_affected="57" subjects_at_risk="1062"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="16" subjects_affected="13" subjects_at_risk="241"/>
                <counts group_id="E2" events="34" subjects_affected="26" subjects_at_risk="598"/>
                <counts group_id="E3" events="64" subjects_affected="51" subjects_at_risk="1062"/>
              </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 Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi</organization>
      <phone>800-633-1610 ext 6#</phone>
      <email>Contact-US@sanofi.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/NCT02255656
org study id: LPS13649
secondary id: 2013-003884-71
secondary id: U1111-1148-2987
nct id: NCT02255656
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Primary Objective:

      To evaluate long-term safety of alemtuzumab.

      Secondary Objectives:

        -  To evaluate long term efficacy of alemtuzumab.

        -  To evaluate the safety profile of participants who received other Disease Modifying
           Treatment (DMT) following alemtuzumab treatment.

        -  To evaluate participant-reported Quality of Life (QoL) outcomes and health resource
           utilization of participant who received alemtuzumab.

        -  To evaluate as needed re-treatment with alemtuzumab and other DMTs.
The total duration per participants was up to 5.6 years.

      As per Study Investigator discretion, participants can be treated with additional courses of
      alemtuzumab or any commercialized DMTs.

      All participants who completed CAMMS03409 were allowed into the study, which might include
      specific vulnerable populations. If the investigator decided to treat a participant with a
      course of alemtuzumab, appropriate cautionary measures were applied as indicated in the
      approved labelling, or, in ex-European Union countries where Lemtrada was not approved,
      according to the investigator's brochure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)
time frame: From Baseline until the end of the study (up to a maximum duration of 5.6 years)
description: An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 [i.e. up to a maximum of 5.6 years]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
measure: Number of Participants With Infusion-Associated Reactions (IAR)
time frame: Within 24 hours of any alemtuzumab infusion
description: Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.
measure: Number of Participants With Adverse Events of Special Interest (AESI)
time frame: From Baseline until the end of the study (up to a maximum duration of 5.6 years)
description: Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.
measure: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities
time frame: From Baseline until the end of the study (up to a maximum duration of 5.6 years)
description: Criteria for potentially clinically significant laboratory abnormalities included:
Hemoglobin (Hb): less than or equal to (<=)115 grams per liter (g/L)(Male [M]), <= 95 g/L (Female[ F]); greater than or equal to (>=)185 g/L (M), >= 165 g/L (F); Decrease From Baseline (DFB) >= 20 g/L.
Hematocrit: <= 0.37 volume/volume (v/v) (M); <= 0.32 v/v (F); >= 0.55 v/v (M); >= 0.5 v/v (F).
Red Blood Cells (RBCs): >=6 *10^12/L.
Platelets: <100 *10^9/L; >=700 *10^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).
measure: Annualized Relapse Rate
time frame: Up to a maximum duration of 5.6 years
description: Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. Annualized relapse rate was obtained from the total number of confirmed relapses that occurred during the treatment follow up time of all participants divided by the total years of follow-up for all participants. The annualized relapse rate was estimated using a negative binomial model with robust variance estimation.
measure: Proportion of Participants Who Were Relapse Free
time frame: Up to a maximum duration of 5.6 years
description: Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination. The proportion of participants who were relapse free (without event) were estimated using the Kaplan-Meier method.
measure: Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
time frame: Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
description: EDSS is an ordinal scale in half-point increments that qualifies disability in participants with multiple sclerosis (MS). It consists of 8 ordinal rating scales assessing seven functional systems (pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other). EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS), where higher scores indicated worst outcomes.
measure: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan
time frame: Up to a maximum duration of 5.6 years
description: Number of Gd-enhancing lesions per scan was defined as the total number of Gd-enhancing lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with generalized estimating equation (GEE) adjusted for analysis groups and geographic region as covariates.
measure: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan
time frame: Up to a maximum duration of 5.6 years
description: Number of new or enlarged T2 lesions per scan was defined as the total number of new or enlarged T2 lesion that occurred during treatment period divided by the total number of scans performed during treatment period. The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.
measure: Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan
time frame: Up to a maximum duration of 5.6 years
description: Number of new T1 lesions per scan was defined as the total number of new T1 lesion (and New Hypointense T1) that occurred during treatment period divided by the total number of scans performed during treatment period.The adjusted cumulative count of lesions was estimated by a repeated negative binomial regression with GEE adjusted for analysis groups and geographic region as covariates.
measure: Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: The total lesion volume (T1 lesions) was measured by MRI scan.
measure: Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: The total lesion volume (T2 lesions) was measured by MRI scan.
measure: Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: The brain parenchymal fraction was measured by MRI scan.
measure: Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: The MOS SF-36 is an extensively validated and widely used measure of QoL that assesses participants' perceptions of health status and its impact on their lives. It consisted of 36 items organized into 8 scales (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health). Two summary measures of physical and mental health, the PCS and MCS, respectively, were derived from scale aggregates, and were reported in this outcome measure. The score range for each of these 2 summary scores was from 0 (worst) to 100 (best), higher scores indicated better QoL.
measure: Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: The FAMS is a self-reported multidimensional index comprising a total of 58 items on 7 subscales: mobility (7 items); symptoms (7 items); emotional well-being (7 items); general contentment (7 items); thinking and fatigue (9 items); family/social well-being (7 items); and additional concerns (14 items, these are not scored). Each item (except those for "additional concerns") was rated on a 5-point scale of 0 (lower quality of life) to 4 (higher quality of life). Total FAMS score was the sum of 44 scored items, which ranged from 0 (poor) to 176 (best), with higher numbers reflecting a higher quality of life.
measure: Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: The EQ-5D is a generic, standardized instrument that provides a simple, descriptive profile and a single index value for health status used in the clinical and economic evaluation of health care as well as in population health surveys. The EQ-5D comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: some, moderate, and extreme problems. The 5 dimensional 3-level systems was converted into single index utility score ranges from 0 to 100, where 100=best health state; and 0=worst health state; higher scores indicated better outcome.
measure: Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0 to 100), where 0=worst imaginable health state to 100=best imaginable health state, and higher score indicated better outcome.
measure: Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS. Questionnaire addresses the following content areas: employment situation and changes in employment situation due to MS;sick leaves,admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments (eg, stair and bed lift, ramps,rails) and devices (eg,walking aids,wheelchairs); assistance by community or social services (e.g. home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported "Yes" as an answer to "employment situation change; had sick leaves; had hospital admission; had spent time in rehabilitation center and had spent time in a nursing home or a similar institution" questions were reported in this outcome measure.
measure: Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRUQ) designed to evaluate the economic impact of MS.Questionnaire addresses following content areas: employment situation and changes in employment situation due to MS; admissions and stays in hospital, rehabilitation centers, or nursing homes; typical MS-related investments(e.g.stair and bed lift,ramps,rails) and devices(e.g.walking aids,wheelchairs);assistance by community or social services(e.g.home nurse, transportation), or help from family or friends. Each question requires a binary answer (yes/no). Number of participants who reported other changes/changes in lifestyle due to MS, i.e."Yes" as an answer to "had made changes to your house, apartment, car or did you require any special equipment or aids; assistance required; other assistance required" questions were reported in this outcome measure.
measure: Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Current employment status of participants (i.e. Part Time/Full Time/Not Employed) was reported in this outcome measure.
measure: HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled working hours of participants; number of hours missed from work by participants due to MS" were reported in this outcome measure.
measure: HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output due to MS were reported in this outcome measure.
measure: HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Data for "total scheduled household chores hours; number of hours missed from planned household chores by participants due to MS" were reported in this outcome measure.
measure: HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis
time frame: Baseline (Month 0 of LPS13649), Month 12, Month 24, Month 36, Month 48 and Month 60
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Percentage impact on work output for household chores due to MS were reported in this outcome measure.
measure: HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis
time frame: Baseline up to end of the study (up to a maximum duration of 5.6 years)
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Mean and standard deviation data for duration of MS disease (in months) since the start of MS development in participants was reported in this outcome measure.
measure: HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis
time frame: Baseline up to end of the study (up to a maximum duration of 5.6 years)
description: Participants use of healthcare resources, non-medical resources, and informal care as well as their work capacity was assessed at scheduled study visits using a modified questionnaire (HRPQ) designed to evaluate the economic impact of MS. The questionnaire addresses the following content area: participant reported data regarding employment status, work productivity, impact on household chores due to MS. Number of participants who reported "Yes" as an answer to questions related to impact on work: "forced me to work part-time when I wanted to work full-time; kept me from having a job when I wanted to work full-time; kept me from having a job when I wanted to work part-time; none of the above" questions were reported in this outcome measure.
arm group label: Alemtuzumab
arm group type: Experimental
description: All Participants who completed the study CAMMS03409 (extension study of CAMMS223 [NCT00050778], CAMMS323 [NCT00530348], or CAMMS324 [NCT00548405]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
intervention type: Drug
intervention name: alemtuzumab GZ402673
description: Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
arm group label: Alemtuzumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: Argentina
country: Australia
country: Belgium
country: Brazil
country: Canada
country: Czechia
country: Denmark
country: Germany
country: Israel
country: Italy
country: Mexico
country: Netherlands
country: Poland
country: Russian Federation
country: Spain
country: Sweden
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
mesh term: Alemtuzumab
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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reported events: 
certain agreements: 
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