<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/NCT01707992</url>
  </required_header>
  <id_info>
    <org_study_id>LAQ-MS-305</org_study_id>
    <secondary_id>2012-003647-30</secondary_id>
    <nct_id>NCT01707992</nct_id>
  </id_info>
  <brief_title>The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)</brief_title>
  <acronym>CONCERTO</acronym>
  <official_title>A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teva Branded Pharmaceutical Products R&amp;D, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Teva Branded Pharmaceutical Products R&amp;D, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multinational, multicenter, randomized, double-blind, parallel-group,&#xD;
      placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and&#xD;
      tolerability of two doses of oral administration of laquinimod in participants with RRMS. The&#xD;
      study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months)&#xD;
      and Period 2, the active treatment period (24 months).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2013</start_date>
  <completion_date type="Actual">July 4, 2017</completion_date>
  <primary_completion_date type="Actual">April 13, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)</measure>
    <time_frame>Baseline to Month 24</time_frame>
    <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15</measure>
    <time_frame>Baseline, Month 15</time_frame>
    <description>Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)</measure>
    <time_frame>Baseline to Month 24</time_frame>
    <description>Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)</measure>
    <time_frame>Baseline to Month 24</time_frame>
    <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)</measure>
    <time_frame>Baseline to Month 24</time_frame>
    <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Baseline up to Month 24</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Active-Treatment Phase: Number of Participants With AEs</measure>
    <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (&gt;=) 120 beats per minute (bpm) and increase from baseline of &gt;=30 bpm, &lt;=45 bpm and decrease from baseline of &gt;=30 bpm; Systolic blood pressure: &gt;=180 millimeters of mercury (mmHg) and increase from baseline of &gt;=30 mmHg, &lt;=90 and decrease from baseline of &gt;=30 mmHg; Diastolic blood pressure: &gt;=100 mmHg and increase from baseline of &gt;=20 mmHg, &lt;=50 mmHg and decrease from baseline of &gt;=20 mmHg.</description>
  </other_outcome>
  <other_outcome>
    <measure>Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities</measure>
    <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
    <description>Clinically significant vital signs abnormalities included: Pulse rate: &gt;=120 bpm and increase from baseline of &gt;=30 bpm, &lt;=45 bpm and decrease from baseline of &gt;=30 bpm; Systolic blood pressure: &gt;=180 mmHg and increase from baseline of &gt;=30 mmHg, &lt;=90 and decrease from baseline of &gt;=30 mmHg; Diastolic blood pressure: &gt;=100 mmHg and increase from baseline of &gt;=20 mmHg, &lt;=50 mmHg and decrease from baseline of &gt;=20 mmHg.</description>
  </other_outcome>
  <other_outcome>
    <measure>Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters</measure>
    <time_frame>Baseline, Endpoint (Month 24)</time_frame>
    <description>ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.</description>
  </other_outcome>
  <other_outcome>
    <measure>Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters</measure>
    <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)</time_frame>
    <description>ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.</description>
  </other_outcome>
  <other_outcome>
    <measure>Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry</measure>
    <time_frame>Baseline up to Month 24</time_frame>
    <description>Potentially clinically significant serum chemistry abnormalities included: Glucose &lt;=3 and &gt;=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter [U/L]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter [mg/L]), pancreatic amylase (in U/L)&gt;=3 * upper limit of normal (ULN); Fibrinogen &gt;=6 grams per liter (gm/L); Sodium &lt;=130 and &gt;=150 mmol/L; Potassium &lt;=3.2 and &gt;=5.5 mmol/L; Calcium &lt;=1.87 and &gt;=2.75 mmol/L; Phosphate &lt;=0.65 and &gt;=1.61 mmol/L.</description>
  </other_outcome>
  <other_outcome>
    <measure>Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry</measure>
    <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
    <description>Potentially clinically significant serum chemistry abnormalities included: Glucose &lt;=3 and &gt;=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)&gt;=3 * ULN; Fibrinogen &gt;=6 gm/L; Sodium &lt;=130 and &gt;=150 mmol/L; Potassium &lt;=3.2 and &gt;=5.5 mmol/L; Calcium &lt;=1.87 and &gt;=2.75 mmol/L; Phosphate &lt;=0.65 and &gt;=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin &gt;=28 micromols per liter (micromols/L); Creatinine &gt;=117 micromols/L; Albumin &lt;=25 gm/L.</description>
  </other_outcome>
  <other_outcome>
    <measure>Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values</measure>
    <time_frame>Baseline up to Month 24</time_frame>
    <description>Potentially clinically significant hematological abnormalities included: Hemoglobin &lt;=11.5 grams per deciliter (gm/dL) in males and &lt;=10 gm/dL in females; White blood cells (WBCs) count &lt;=2.5 and &gt;=21*10^9 per liter (L); Absolute neutrophil count (ANC) &lt;=1.49*10^9 per L; Platelet count &lt;=100 and &gt;=600*10^9 per L.</description>
  </other_outcome>
  <other_outcome>
    <measure>Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values</measure>
    <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
    <description>Potentially clinically significant hematological abnormalities included: Hemoglobin &lt;=11.5, &gt;=20 gm/dL in males, and &lt;=10, &gt;=18.5 gm/dL in females; WBCs count &lt;=2.5 and &gt;=21*10^9 per L; ANC &lt;=1.49*10^9 per L; Platelet count &lt;=100 and &gt;=600*10^9 per L.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">2199</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Placebo-Controlled Phase: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo-Controlled Phase: Laquinimod 0.6 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo-Controlled Phase: Laquinimod 1.2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Treatment Phase: Laquinimod 0.6 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Treatment Phase: Laquinimod 1.2 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Treatment Phase: Off Drug</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 will continue the active-treatment phase off drug for 24 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Laquinimod</intervention_name>
    <description>Laquinimod will be administered as per the dose and schedule specified in the respective arms.</description>
    <arm_group_label>Active Treatment Phase: Laquinimod 0.6 mg</arm_group_label>
    <arm_group_label>Active Treatment Phase: Laquinimod 1.2 mg</arm_group_label>
    <arm_group_label>Placebo-Controlled Phase: Laquinimod 0.6 mg</arm_group_label>
    <arm_group_label>Placebo-Controlled Phase: Laquinimod 1.2 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.</description>
    <arm_group_label>Active Treatment Phase: Laquinimod 0.6 mg</arm_group_label>
    <arm_group_label>Placebo-Controlled Phase: Laquinimod 0.6 mg</arm_group_label>
    <arm_group_label>Placebo-Controlled Phase: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have a confirmed and documented multiple sclerosis (MS) diagnosis as&#xD;
             defined by the Revised McDonald criteria, with relapse onset disease or a&#xD;
             relapsing-remitting disease course.&#xD;
&#xD;
          -  Participants must be ambulatory with Kurtzke's expanded disability status scale (EDSS)&#xD;
             score of 0 to 5.5 in both screening and randomization visits.&#xD;
&#xD;
          -  Participants must be in a stable neurological condition, relapse-free and free of any&#xD;
             corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os&#xD;
             (PO)/oral] or adrenocorticotrophic hormone, 60 days prior to randomization.&#xD;
&#xD;
          -  Participants must have experienced at least one documented relapse in the 12 months&#xD;
             prior to randomization.&#xD;
&#xD;
          -  Participants must have disease duration of not more than 15 years.&#xD;
&#xD;
          -  Women of child-bearing potential (for example, women who are not postmenopausal or&#xD;
             surgically sterilized) must practice an acceptable method of birth control for 30 days&#xD;
             before taking the study drug and two acceptable methods of birth control during the&#xD;
             duration of the study and until 30 days after the last dose of study medication.&#xD;
&#xD;
               -  Additional criteria apply, please contact the investigator for more information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with progressive forms of MS.&#xD;
&#xD;
          -  Participants with neuromyelitis optica.&#xD;
&#xD;
          -  Use of experimental or investigational drugs and/or participation in drug clinical&#xD;
             studies within the 6 months prior to randomization.&#xD;
&#xD;
          -  Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide,&#xD;
             within 6 months prior to randomization.&#xD;
&#xD;
          -  Use of either of the following within 2 years prior to randomization visit:&#xD;
             natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.&#xD;
&#xD;
          -  Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if&#xD;
             active washout (with either cholestyramine or activated charcoal) was done 2 months or&#xD;
             more prior to randomization.&#xD;
&#xD;
          -  Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b),&#xD;
             fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulins&#xD;
             within 2 months prior to randomization.&#xD;
&#xD;
          -  Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid&#xD;
             treatment within 2 months prior to randomization.&#xD;
&#xD;
          -  Previous use of mitoxantrone (Novantrone®), cladribine, or alemtuzumab (Lemtrada®).&#xD;
&#xD;
          -  Previous use of laquinimod.&#xD;
&#xD;
          -  Previous total body irradiation or total lymphoid irradiation.&#xD;
&#xD;
          -  Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone&#xD;
             marrow transplantation.&#xD;
&#xD;
          -  Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to&#xD;
             randomization.&#xD;
&#xD;
          -  Use of inducers of CYP3A4 within 2 weeks prior to randomization visit.&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
&#xD;
          -  A known history of sensitivity to gadolinium (Gd).&#xD;
&#xD;
          -  Inability to successfully undergo magnetic resonance imaging (MRI) scanning.&#xD;
&#xD;
          -  Participants who underwent endovascular treatment for chronic cerebrospinal venous&#xD;
             insufficiency within 3 months prior to randomization.&#xD;
&#xD;
               -  Additional criteria apply, please contact the investigator for more information.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teva Medical Expert, MD</last_name>
    <role>Study Director</role>
    <affiliation>Teva Branded Pharmaceutical Products R&amp;D, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Teva Investigational Site 10329</name>
      <address>
        <city>Cullman</city>
        <state>Alabama</state>
        <zip>35058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10349</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10342</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741-3537</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10310</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10307</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10334</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10332</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10316</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10341</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10308</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10315</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10323</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10350</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10345</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10343</name>
      <address>
        <city>Northbrook</city>
        <state>Illinois</state>
        <zip>60062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10339</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10348</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10338</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10346</name>
      <address>
        <city>Advance</city>
        <state>North Carolina</state>
        <zip>27006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10347</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10309</name>
      <address>
        <city>Bellevue</city>
        <state>Ohio</state>
        <zip>44811</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10317</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10325</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10340</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10331</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10313</name>
      <address>
        <city>Cordova</city>
        <state>Tennessee</state>
        <zip>38018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10324</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10318</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10319</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10330</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10311</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 10335</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 33013</name>
      <address>
        <city>Innsbruck</city>
        <zip>A-6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 33014</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 33016</name>
      <address>
        <city>Wien</city>
        <zip>1010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 33015</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 68010</name>
      <address>
        <city>Gomel</city>
        <zip>246029</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 68013</name>
      <address>
        <city>Grodno</city>
        <zip>230027</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 68012</name>
      <address>
        <city>Minsk</city>
        <zip>220026</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 68009</name>
      <address>
        <city>Minsk</city>
        <zip>220114</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 68008</name>
      <address>
        <city>Minsk</city>
        <zip>220116</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 68011</name>
      <address>
        <city>Vitebsk</city>
        <zip>210023</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 37023</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 37024</name>
      <address>
        <city>Sijsele</city>
        <zip>8340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 69008</name>
      <address>
        <city>Mostar</city>
        <zip>88000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 69006</name>
      <address>
        <city>Sarajevo</city>
        <zip>71000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 69009</name>
      <address>
        <city>Tuzla</city>
        <zip>75000</zip>
        <country>Bosnia and Herzegovina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59039</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59040</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59060</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59062</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59061</name>
      <address>
        <city>Ruse</city>
        <zip>7003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59055</name>
      <address>
        <city>Shumen</city>
        <zip>9700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59048</name>
      <address>
        <city>Sofia</city>
        <zip>1113</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59052</name>
      <address>
        <city>Sofia</city>
        <zip>1113</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59057</name>
      <address>
        <city>Sofia</city>
        <zip>1113</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59050</name>
      <address>
        <city>Sofia</city>
        <zip>1142</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59044</name>
      <address>
        <city>Sofia</city>
        <zip>1309</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59063</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59038</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59043</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59058</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59041</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59042</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59054</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59059</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59045</name>
      <address>
        <city>Sofia</city>
        <zip>1750</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59049</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59046</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59051</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 59053</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5100</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11013</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11014</name>
      <address>
        <city>Burnaby</city>
        <state>British Columbia</state>
        <zip>V5G 2X6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11015</name>
      <address>
        <city>Ottawa</city>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 11016</name>
      <address>
        <city>Saskatoon</city>
        <zip>S7K 0M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 60010</name>
      <address>
        <city>Osijek</city>
        <zip>31 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 60011</name>
      <address>
        <city>Varazdin</city>
        <zip>42000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 60009</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54042</name>
      <address>
        <city>Brno</city>
        <zip>602 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54043</name>
      <address>
        <city>Havirov</city>
        <zip>736 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54047</name>
      <address>
        <city>Hradec Kralove 3</city>
        <zip>50003</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54046</name>
      <address>
        <city>Jihlava</city>
        <zip>58633</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54044</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54045</name>
      <address>
        <city>Ostrava</city>
        <zip>702 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54049</name>
      <address>
        <city>Praha 10</city>
        <zip>100 31</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54041</name>
      <address>
        <city>Praha</city>
        <zip>104 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 54048</name>
      <address>
        <city>Teplice</city>
        <zip>415 29</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 55005</name>
      <address>
        <city>Parnu</city>
        <zip>80010</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 55008</name>
      <address>
        <city>Tallinn</city>
        <zip>EE-10138</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 55006</name>
      <address>
        <city>Tallinn</city>
        <zip>EE-10617</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 55007</name>
      <address>
        <city>Tartu</city>
        <zip>EE-51014</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 35075</name>
      <address>
        <city>Clermont-Ferrand Cedex 1</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 35077</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 35073</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 35076</name>
      <address>
        <city>Lyon cedex 04</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 35079</name>
      <address>
        <city>Nimes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 81018</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 81014</name>
      <address>
        <city>Tbilisi</city>
        <zip>0141</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 81015</name>
      <address>
        <city>Tbilisi</city>
        <zip>0179</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 81019</name>
      <address>
        <city>Tbilisi</city>
        <zip>0179</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 81017</name>
      <address>
        <city>Tbilisi</city>
        <zip>0186</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 81016</name>
      <address>
        <city>Tbilisi</city>
        <zip>0194</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32199</name>
      <address>
        <city>Bad Mergentheim</city>
        <zip>97980</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32195</name>
      <address>
        <city>Berg</city>
        <zip>82335</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32200</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32186</name>
      <address>
        <city>Berlin</city>
        <zip>10437</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32176</name>
      <address>
        <city>Berlin</city>
        <zip>10625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32174</name>
      <address>
        <city>Berlin</city>
        <zip>10713</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32198</name>
      <address>
        <city>Berlin</city>
        <zip>12163</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32177</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32193</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32184</name>
      <address>
        <city>Erbach</city>
        <zip>64711</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32189</name>
      <address>
        <city>Erfurt</city>
        <zip>99089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32203</name>
      <address>
        <city>Giessen</city>
        <zip>35385</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32202</name>
      <address>
        <city>Goettigen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32196</name>
      <address>
        <city>Halle (Saale)</city>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32181</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32179</name>
      <address>
        <city>Hamburg</city>
        <zip>22083</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32182</name>
      <address>
        <city>Hannover</city>
        <zip>30171</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32175</name>
      <address>
        <city>Ibbenburen</city>
        <zip>49477</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32201</name>
      <address>
        <city>Jena</city>
        <zip>07743</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32183</name>
      <address>
        <city>Koln</city>
        <zip>50935</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32190</name>
      <address>
        <city>Leipzig</city>
        <zip>4103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32185</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32191</name>
      <address>
        <city>Rostock</city>
        <zip>18147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32194</name>
      <address>
        <city>Teupitz</city>
        <zip>15755</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32173</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32197</name>
      <address>
        <city>Wermsdorf</city>
        <zip>04773</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 32188</name>
      <address>
        <city>Westerstede</city>
        <zip>26655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 63027</name>
      <address>
        <city>Athens</city>
        <zip>115 28</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 63024</name>
      <address>
        <city>Athens</city>
        <zip>11525</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 63029</name>
      <address>
        <city>Chaidari</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 63026</name>
      <address>
        <city>Heraklion</city>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 63030</name>
      <address>
        <city>Larisa</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 63025</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54636</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 63028</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 51046</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 51043</name>
      <address>
        <city>Debrecen</city>
        <zip>4043</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 51045</name>
      <address>
        <city>Eger</city>
        <zip>H-3300</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 51044</name>
      <address>
        <city>Kaposvar</city>
        <zip>H-7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80023</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80024</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80020</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262160</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 80021</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30037</name>
      <address>
        <city>Bologna</city>
        <zip>40139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30031</name>
      <address>
        <city>Castelfiorentino</city>
        <zip>50051</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30030</name>
      <address>
        <city>Cefalu</city>
        <zip>90015</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30032</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30024</name>
      <address>
        <city>Firenze</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30029</name>
      <address>
        <city>Gallarate</city>
        <zip>21013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30023</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30039</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30034</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30027</name>
      <address>
        <city>Palermo</city>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30028</name>
      <address>
        <city>Rome</city>
        <zip>00149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30025</name>
      <address>
        <city>Rome</city>
        <zip>00163</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30026</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30035</name>
      <address>
        <city>Rome</city>
        <zip>00178</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 30040</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 87001</name>
      <address>
        <city>Goyang-si</city>
        <zip>410-769</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 87003</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 87002</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 56006</name>
      <address>
        <city>Riga</city>
        <zip>1038</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 56005</name>
      <address>
        <city>Riga</city>
        <zip>LV-1005</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 70006</name>
      <address>
        <city>Chisinau</city>
        <zip>2001</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 70005</name>
      <address>
        <city>Chisinau</city>
        <zip>2024</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 70008</name>
      <address>
        <city>Chisinau</city>
        <zip>2028</zip>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 66002</name>
      <address>
        <city>Podgorica</city>
        <zip>20000</zip>
        <country>Montenegro</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 65010</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 65011</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 65012</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53066</name>
      <address>
        <city>Bialystok</city>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53071</name>
      <address>
        <city>Bialystok</city>
        <zip>15-402</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53085</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-654</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53084</name>
      <address>
        <city>Czestochowa</city>
        <zip>42-280</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53069</name>
      <address>
        <city>Gdansk</city>
        <zip>80-299</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53083</name>
      <address>
        <city>Gdansk</city>
        <zip>80-546</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53067</name>
      <address>
        <city>Gdansk</city>
        <zip>80-803</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53078</name>
      <address>
        <city>Grodzisk Mazowiecki</city>
        <zip>05-825</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53080</name>
      <address>
        <city>Katowice</city>
        <zip>40-555</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53081</name>
      <address>
        <city>Katowice</city>
        <zip>40-650</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53073</name>
      <address>
        <city>Katowice</city>
        <zip>40-684</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53070</name>
      <address>
        <city>Katowice</city>
        <zip>40-749</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53074</name>
      <address>
        <city>Katowice</city>
        <zip>40-752</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53064</name>
      <address>
        <city>Konskie</city>
        <zip>26-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53065</name>
      <address>
        <city>Konstancin-Jeziorna</city>
        <zip>05-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53072</name>
      <address>
        <city>Koscierzyna</city>
        <zip>83-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53063</name>
      <address>
        <city>Lodz</city>
        <zip>90-324</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53079</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-560</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53068</name>
      <address>
        <city>Plewiska</city>
        <zip>62-064</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 53076</name>
      <address>
        <city>Szczecin</city>
        <zip>70-111</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52045</name>
      <address>
        <city>Balotesti</city>
        <zip>77015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52041</name>
      <address>
        <city>Bucharest</city>
        <zip>012071</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52050</name>
      <address>
        <city>Bucuresti</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52037</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52034</name>
      <address>
        <city>Bucuresti</city>
        <zip>050098</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52040</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400006</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52036</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400437</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52038</name>
      <address>
        <city>Constanta</city>
        <zip>900123</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52044</name>
      <address>
        <city>Constanta</city>
        <zip>900591</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52048</name>
      <address>
        <city>Craiova</city>
        <zip>200473</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52049</name>
      <address>
        <city>Hunedoara</city>
        <zip>331057</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52042</name>
      <address>
        <city>Iasi</city>
        <zip>700661</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52039</name>
      <address>
        <city>Oradea</city>
        <zip>410108</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52047</name>
      <address>
        <city>Piatra-Neamt</city>
        <zip>610136</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52046</name>
      <address>
        <city>Sibiu</city>
        <zip>550245</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52035</name>
      <address>
        <city>Targu Mures</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 52043</name>
      <address>
        <city>Timisoara</city>
        <zip>100182</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50130</name>
      <address>
        <city>Barnaul</city>
        <zip>656024</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50129</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50208</name>
      <address>
        <city>Kazan</city>
        <zip>420021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50148</name>
      <address>
        <city>Kemerovo</city>
        <zip>650061</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50144</name>
      <address>
        <city>Krasnodar</city>
        <zip>350012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50147</name>
      <address>
        <city>Moscow</city>
        <zip>119021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50124</name>
      <address>
        <city>Moscow</city>
        <zip>127015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50133</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50146</name>
      <address>
        <city>Moscow</city>
        <zip>129128</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50141</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603076</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50128</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603155</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50131</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603155</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50127</name>
      <address>
        <city>Perm</city>
        <zip>614990</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50143</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50149</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50126</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>191186</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50140</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50138</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50135</name>
      <address>
        <city>Saratov</city>
        <zip>410054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50136</name>
      <address>
        <city>Smolensk</city>
        <zip>214018</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50137</name>
      <address>
        <city>St. Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50125</name>
      <address>
        <city>Tomsk</city>
        <zip>634050</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50139</name>
      <address>
        <city>Tyumen</city>
        <zip>625000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50134</name>
      <address>
        <city>Ufa</city>
        <zip>450007</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50132</name>
      <address>
        <city>Volgograd</city>
        <zip>400138</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 50142</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61025</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61027</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61024</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61018</name>
      <address>
        <city>Cacak</city>
        <zip>32000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61015</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61014</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61019</name>
      <address>
        <city>Sombor</city>
        <zip>25000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61016</name>
      <address>
        <city>Subotica</city>
        <zip>24000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61017</name>
      <address>
        <city>Uzice</city>
        <zip>31000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61022</name>
      <address>
        <city>Valjevo</city>
        <zip>14000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61026</name>
      <address>
        <city>Vrbas</city>
        <zip>21460</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 61021</name>
      <address>
        <city>Zrenjanin</city>
        <zip>23000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 62012</name>
      <address>
        <city>Hlohovec</city>
        <zip>92001</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 62013</name>
      <address>
        <city>Trnava</city>
        <zip>917 75</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31035</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31030</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31031</name>
      <address>
        <city>Getafe</city>
        <zip>28905</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31036</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31032</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31034</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31033</name>
      <address>
        <city>Navarro</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31039</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 31037</name>
      <address>
        <city>Salt</city>
        <zip>17190</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58087</name>
      <address>
        <city>Chernihiv</city>
        <zip>14001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58083</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58077</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49044</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58088</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76008</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58076</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58116</name>
      <address>
        <city>Kharkiv</city>
        <zip>61068</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58084</name>
      <address>
        <city>Kharkiv</city>
        <zip>61103</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58089</name>
      <address>
        <city>Kiev</city>
        <zip>04112</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58073</name>
      <address>
        <city>Kyiv</city>
        <zip>01601</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58078</name>
      <address>
        <city>Kyiv</city>
        <zip>03110</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58081</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58115</name>
      <address>
        <city>Lviv</city>
        <zip>79013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58086</name>
      <address>
        <city>Lviv</city>
        <zip>79059</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58074</name>
      <address>
        <city>Odesa</city>
        <zip>65025</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58085</name>
      <address>
        <city>Odessa</city>
        <zip>65014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58082</name>
      <address>
        <city>Poltava</city>
        <zip>36024</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58080</name>
      <address>
        <city>Simferopol</city>
        <zip>95000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58072</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58079</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 58075</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 34015</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 34011</name>
      <address>
        <city>Liverpool</city>
        <zip>B0T 1K0</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 34010</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 34019</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 34016</name>
      <address>
        <city>Salford</city>
        <zip>M6 8HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 34017</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teva Investigational Site 34013</name>
      <address>
        <city>Stoke-on-Trent</city>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Bosnia and Herzegovina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Moldova, Republic of</country>
    <country>Montenegro</country>
    <country>North Macedonia</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>Kazakhstan</country>
    <country>Macedonia, The Former Yugoslav Republic of</country>
    <country>Mexico</country>
    <country>Portugal</country>
  </removed_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>February 20, 2019</results_first_submitted>
  <results_first_submitted_qc>February 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">March 13, 2019</results_first_posted>
  <disposition_first_submitted>May 2, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>May 2, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 3, 2018</disposition_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2021</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>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study was conducted at 215 sites in 29 countries.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo-Controlled Phase: Placebo</title>
          <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.</description>
        </group>
        <group group_id="P2">
          <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
          <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
        </group>
        <group group_id="P3">
          <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
          <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
        </group>
        <group group_id="P4">
          <title>Active Treatment Phase: Laquinimod 0.6 mg</title>
          <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
        </group>
        <group group_id="P5">
          <title>Active Treatment Phase: Laquinimod 1.2 mg</title>
          <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
        </group>
        <group group_id="P6">
          <title>Active Treatment Phase: Off Drug</title>
          <description>Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 continued to the active-treatment phase off drug for 24 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Placebo-Controlled Phase (24 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="740"/>
                <participants group_id="P2" count="727"/>
                <participants group_id="P3" count="732"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="596"/>
                <participants group_id="P2" count="623"/>
                <participants group_id="P3" count="532"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="104"/>
                <participants group_id="P3" count="200"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="154"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance with drug administration</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Active Treatment Phase (24 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="891"/>
                <participants group_id="P5" count="504"/>
                <participants group_id="P6" count="215"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="884"/>
                <participants group_id="P5" count="494"/>
                <participants group_id="P6" count="215"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="58"/>
                <participants group_id="P5" count="220"/>
                <participants group_id="P6" count="32"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="809"/>
                <participants group_id="P5" count="243"/>
                <participants group_id="P6" count="174"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew per Sponsor request</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) analysis set included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo-Controlled Phase: Placebo</title>
          <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
        </group>
        <group group_id="B2">
          <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
          <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
        </group>
        <group group_id="B3">
          <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
          <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="740"/>
            <count group_id="B2" value="727"/>
            <count group_id="B3" value="732"/>
            <count group_id="B4" value="2199"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                    <count group_id="B2" value="727"/>
                    <count group_id="B3" value="732"/>
                    <count group_id="B4" value="2199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.9" spread="8.95"/>
                    <measurement group_id="B2" value="36.8" spread="9.25"/>
                    <measurement group_id="B3" value="36.1" spread="9.22"/>
                    <measurement group_id="B4" value="36.3" spread="9.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                    <count group_id="B2" value="727"/>
                    <count group_id="B3" value="732"/>
                    <count group_id="B4" value="2199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Adults (18-64 years)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="740"/>
                    <measurement group_id="B2" value="727"/>
                    <measurement group_id="B3" value="732"/>
                    <measurement group_id="B4" value="2199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                    <count group_id="B2" value="727"/>
                    <count group_id="B3" value="732"/>
                    <count group_id="B4" value="2199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="488"/>
                    <measurement group_id="B2" value="510"/>
                    <measurement group_id="B3" value="475"/>
                    <measurement group_id="B4" value="1473"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="217"/>
                    <measurement group_id="B3" value="257"/>
                    <measurement group_id="B4" value="726"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                    <count group_id="B2" value="727"/>
                    <count group_id="B3" value="732"/>
                    <count group_id="B4" value="2199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="724"/>
                    <measurement group_id="B2" value="712"/>
                    <measurement group_id="B3" value="717"/>
                    <measurement group_id="B4" value="2153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kurtzke's Expanded Disability Status Scale (EDSS) Score</title>
          <description>EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                    <count group_id="B2" value="727"/>
                    <count group_id="B3" value="732"/>
                    <count group_id="B4" value="2199"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than or equal to (&lt;=) 4.0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="653"/>
                    <measurement group_id="B2" value="635"/>
                    <measurement group_id="B3" value="644"/>
                    <measurement group_id="B4" value="1932"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Greater than (&gt;) 4.0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="88"/>
                    <measurement group_id="B4" value="265"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Normalized Brain Volume</title>
          <population>This characteristic was analyzed for a total of 2187 participants (Placebo [737], Laquinimod 0.6 mg [722], and Laquinimod 1.2 mg [728])</population>
          <units>milliliters (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="737"/>
                    <count group_id="B2" value="722"/>
                    <count group_id="B3" value="728"/>
                    <count group_id="B4" value="2187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1437.2" spread="93.37"/>
                    <measurement group_id="B2" value="1433.0" spread="92.49"/>
                    <measurement group_id="B3" value="1434.4" spread="93.41"/>
                    <measurement group_id="B4" value="1434.9" spread="93.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)</title>
        <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.</description>
        <time_frame>Baseline to Month 24</time_frame>
        <population>ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)</title>
          <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.</description>
          <population>ITT analysis set included all randomized participants.</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="740"/>
                <count group_id="O2" value="727"/>
                <count group_id="O3" value="732"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to [&lt;=] 4 or greater than [&gt;] 4), country/geographical region (CGR), categorical age at baseline (&lt;=38 or &gt;38), and T2 volume at baseline were included as covariates in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.7057</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.937</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.668</ci_lower_limit>
            <ci_upper_limit>1.313</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15</title>
        <description>Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.</description>
        <time_frame>Baseline, Month 15</time_frame>
        <population>The modified intent-to-treat 1 (mITT1) analysis set included data from all randomized participants at the Month 15 visit. Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15</title>
          <description>Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.</description>
          <population>The modified intent-to-treat 1 (mITT1) analysis set included data from all randomized participants at the Month 15 visit. Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure.</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="619"/>
                <count group_id="O2" value="636"/>
                <count group_id="O3" value="616"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.02" lower_limit="1.02"/>
                    <measurement group_id="O2" value="-0.4" spread="1.01" lower_limit="1.01"/>
                    <measurement group_id="O3" value="-0.4" spread="1.05" lower_limit="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)</title>
        <description>Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).</description>
        <time_frame>Baseline to Month 24</time_frame>
        <population>ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)</title>
          <description>Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).</description>
          <population>ITT analysis set included all randomized participants.</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="740"/>
                <count group_id="O2" value="727"/>
                <count group_id="O3" value="732"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="332"/>
                    <measurement group_id="O2" value="269"/>
                    <measurement group_id="O3" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)</title>
        <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.</description>
        <time_frame>Baseline to Month 24</time_frame>
        <population>ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)</title>
          <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.</description>
          <population>ITT analysis set included all randomized participants.</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="740"/>
                <count group_id="O2" value="727"/>
                <count group_id="O3" value="732"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)</title>
        <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.</description>
        <time_frame>Baseline to Month 24</time_frame>
        <population>ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)</title>
          <description>Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.</description>
          <population>ITT analysis set included all randomized participants.</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="740"/>
                <count group_id="O2" value="727"/>
                <count group_id="O3" value="732"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.</description>
        <time_frame>Baseline up to Month 24</time_frame>
        <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.</description>
          <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug.</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="740"/>
                <count group_id="O2" value="727"/>
                <count group_id="O3" value="732"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="546"/>
                    <measurement group_id="O2" value="565"/>
                    <measurement group_id="O3" value="575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Active-Treatment Phase: Number of Participants With AEs</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.</description>
        <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
        <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Treatment Phase: Laquinimod 0.6 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Active Treatment Phase: Laquinimod 1.2 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Active-Treatment Phase: Number of Participants With AEs</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.</description>
          <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</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="891"/>
                <count group_id="O2" value="504"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="442"/>
                    <measurement group_id="O2" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities</title>
        <description>Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (&gt;=) 120 beats per minute (bpm) and increase from baseline of &gt;=30 bpm, &lt;=45 bpm and decrease from baseline of &gt;=30 bpm; Systolic blood pressure: &gt;=180 millimeters of mercury (mmHg) and increase from baseline of &gt;=30 mmHg, &lt;=90 and decrease from baseline of &gt;=30 mmHg; Diastolic blood pressure: &gt;=100 mmHg and increase from baseline of &gt;=20 mmHg, &lt;=50 mmHg and decrease from baseline of &gt;=20 mmHg.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities</title>
          <description>Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (&gt;=) 120 beats per minute (bpm) and increase from baseline of &gt;=30 bpm, &lt;=45 bpm and decrease from baseline of &gt;=30 bpm; Systolic blood pressure: &gt;=180 millimeters of mercury (mmHg) and increase from baseline of &gt;=30 mmHg, &lt;=90 and decrease from baseline of &gt;=30 mmHg; Diastolic blood pressure: &gt;=100 mmHg and increase from baseline of &gt;=20 mmHg, &lt;=50 mmHg and decrease from baseline of &gt;=20 mmHg.</description>
          <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug.</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="740"/>
                <count group_id="O2" value="727"/>
                <count group_id="O3" value="732"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities</title>
        <description>Clinically significant vital signs abnormalities included: Pulse rate: &gt;=120 bpm and increase from baseline of &gt;=30 bpm, &lt;=45 bpm and decrease from baseline of &gt;=30 bpm; Systolic blood pressure: &gt;=180 mmHg and increase from baseline of &gt;=30 mmHg, &lt;=90 and decrease from baseline of &gt;=30 mmHg; Diastolic blood pressure: &gt;=100 mmHg and increase from baseline of &gt;=20 mmHg, &lt;=50 mmHg and decrease from baseline of &gt;=20 mmHg.</description>
        <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
        <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Treatment Phase: Laquinimod 0.6 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Active Treatment Phase: Laquinimod 1.2 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities</title>
          <description>Clinically significant vital signs abnormalities included: Pulse rate: &gt;=120 bpm and increase from baseline of &gt;=30 bpm, &lt;=45 bpm and decrease from baseline of &gt;=30 bpm; Systolic blood pressure: &gt;=180 mmHg and increase from baseline of &gt;=30 mmHg, &lt;=90 and decrease from baseline of &gt;=30 mmHg; Diastolic blood pressure: &gt;=100 mmHg and increase from baseline of &gt;=20 mmHg, &lt;=50 mmHg and decrease from baseline of &gt;=20 mmHg.</description>
          <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</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="891"/>
                <count group_id="O2" value="504"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters</title>
        <description>ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.</description>
        <time_frame>Baseline, Endpoint (Month 24)</time_frame>
        <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters</title>
          <description>ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.</description>
          <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="734"/>
                <count group_id="O2" value="723"/>
                <count group_id="O3" value="724"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Normal - Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="463"/>
                    <measurement group_id="O2" value="467"/>
                    <measurement group_id="O3" value="470"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal - Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                    <measurement group_id="O2" value="124"/>
                    <measurement group_id="O3" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal - Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS - Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS - Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS - Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS - Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS - Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS - Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters</title>
        <description>ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.</description>
        <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)</time_frame>
        <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase and had ECG shift from baseline data available.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Treatment Phase: Laquinimod 0.6 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Active Treatment Phase: Laquinimod 1.2 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters</title>
          <description>ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.</description>
          <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase and had ECG shift from baseline data available.</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="888"/>
                <count group_id="O2" value="501"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Normal - Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="641"/>
                    <measurement group_id="O2" value="353"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal - Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="137"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Normal - Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS - Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS - Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal NCS - Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS - Normal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS - Abnormal NCS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Abnormal CS - Abnormal CS</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry</title>
        <description>Potentially clinically significant serum chemistry abnormalities included: Glucose &lt;=3 and &gt;=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter [U/L]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter [mg/L]), pancreatic amylase (in U/L)&gt;=3 * upper limit of normal (ULN); Fibrinogen &gt;=6 grams per liter (gm/L); Sodium &lt;=130 and &gt;=150 mmol/L; Potassium &lt;=3.2 and &gt;=5.5 mmol/L; Calcium &lt;=1.87 and &gt;=2.75 mmol/L; Phosphate &lt;=0.65 and &gt;=1.61 mmol/L.</description>
        <time_frame>Baseline up to Month 24</time_frame>
        <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry</title>
          <description>Potentially clinically significant serum chemistry abnormalities included: Glucose &lt;=3 and &gt;=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter [U/L]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter [mg/L]), pancreatic amylase (in U/L)&gt;=3 * upper limit of normal (ULN); Fibrinogen &gt;=6 grams per liter (gm/L); Sodium &lt;=130 and &gt;=150 mmol/L; Potassium &lt;=3.2 and &gt;=5.5 mmol/L; Calcium &lt;=1.87 and &gt;=2.75 mmol/L; Phosphate &lt;=0.65 and &gt;=1.61 mmol/L.</description>
          <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="736"/>
                <count group_id="O2" value="723"/>
                <count group_id="O3" value="724"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="165"/>
                    <measurement group_id="O3" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry</title>
        <description>Potentially clinically significant serum chemistry abnormalities included: Glucose &lt;=3 and &gt;=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)&gt;=3 * ULN; Fibrinogen &gt;=6 gm/L; Sodium &lt;=130 and &gt;=150 mmol/L; Potassium &lt;=3.2 and &gt;=5.5 mmol/L; Calcium &lt;=1.87 and &gt;=2.75 mmol/L; Phosphate &lt;=0.65 and &gt;=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin &gt;=28 micromols per liter (micromols/L); Creatinine &gt;=117 micromols/L; Albumin &lt;=25 gm/L.</description>
        <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
        <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Treatment Phase: Laquinimod 0.6 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Active Treatment Phase: Laquinimod 1.2 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry</title>
          <description>Potentially clinically significant serum chemistry abnormalities included: Glucose &lt;=3 and &gt;=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)&gt;=3 * ULN; Fibrinogen &gt;=6 gm/L; Sodium &lt;=130 and &gt;=150 mmol/L; Potassium &lt;=3.2 and &gt;=5.5 mmol/L; Calcium &lt;=1.87 and &gt;=2.75 mmol/L; Phosphate &lt;=0.65 and &gt;=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin &gt;=28 micromols per liter (micromols/L); Creatinine &gt;=117 micromols/L; Albumin &lt;=25 gm/L.</description>
          <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</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="891"/>
                <count group_id="O2" value="504"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="887"/>
                    <measurement group_id="O2" value="501"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values</title>
        <description>Potentially clinically significant hematological abnormalities included: Hemoglobin &lt;=11.5 grams per deciliter (gm/dL) in males and &lt;=10 gm/dL in females; White blood cells (WBCs) count &lt;=2.5 and &gt;=21*10^9 per liter (L); Absolute neutrophil count (ANC) &lt;=1.49*10^9 per L; Platelet count &lt;=100 and &gt;=600*10^9 per L.</description>
        <time_frame>Baseline up to Month 24</time_frame>
        <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo-Controlled Phase: Placebo</title>
            <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
            <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
          </group>
          <group group_id="O3">
            <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
            <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values</title>
          <description>Potentially clinically significant hematological abnormalities included: Hemoglobin &lt;=11.5 grams per deciliter (gm/dL) in males and &lt;=10 gm/dL in females; White blood cells (WBCs) count &lt;=2.5 and &gt;=21*10^9 per liter (L); Absolute neutrophil count (ANC) &lt;=1.49*10^9 per L; Platelet count &lt;=100 and &gt;=600*10^9 per L.</description>
          <population>Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="735"/>
                <count group_id="O2" value="723"/>
                <count group_id="O3" value="723"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values</title>
        <description>Potentially clinically significant hematological abnormalities included: Hemoglobin &lt;=11.5, &gt;=20 gm/dL in males, and &lt;=10, &gt;=18.5 gm/dL in females; WBCs count &lt;=2.5 and &gt;=21*10^9 per L; ANC &lt;=1.49*10^9 per L; Platelet count &lt;=100 and &gt;=600*10^9 per L.</description>
        <time_frame>Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase</time_frame>
        <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Treatment Phase: Laquinimod 0.6 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
          </group>
          <group group_id="O2">
            <title>Active Treatment Phase: Laquinimod 1.2 mg</title>
            <description>Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values</title>
          <description>Potentially clinically significant hematological abnormalities included: Hemoglobin &lt;=11.5, &gt;=20 gm/dL in males, and &lt;=10, &gt;=18.5 gm/dL in females; WBCs count &lt;=2.5 and &gt;=21*10^9 per L; ANC &lt;=1.49*10^9 per L; Platelet count &lt;=100 and &gt;=600*10^9 per L.</description>
          <population>Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.</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="891"/>
                <count group_id="O2" value="504"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="886"/>
                    <measurement group_id="O2" value="499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo-Controlled Phase: Laquinimod 0.6 mg</title>
          <description>Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.</description>
        </group>
        <group group_id="E2">
          <title>Placebo-Controlled Phase: Laquinimod 1.2 mg</title>
          <description>Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.</description>
        </group>
        <group group_id="E3">
          <title>Placebo-Controlled Phase: Placebo</title>
          <description>Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.</description>
        </group>
        <group group_id="E4">
          <title>Active Treatment Phase: Early Laquinimod 0.6 mg</title>
          <description>Participants who completed the placebo-controlled phase on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
        </group>
        <group group_id="E5">
          <title>Active Treatment Phase: Early Laquinimod 1.2 mg</title>
          <description>Participants who completed the placebo-controlled phase on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
        </group>
        <group group_id="E6">
          <title>Active Treatment Phase: Off Drug</title>
          <description>Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016, continued to the active-treatment phase off drug for 24 months.</description>
        </group>
        <group group_id="E7">
          <title>Active Treatment Phase: From Placebo to Laquinimod 0.6 mg</title>
          <description>Participants who completed the placebo-controlled phase on placebo treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.</description>
        </group>
        <group group_id="E8">
          <title>Active Treatment Phase: From Placebo to Laquinimod 1.2 mg</title>
          <description>Participants who completed the placebo-controlled phase on placebo treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</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="1" subjects_at_risk="727"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="740"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="580"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="57" subjects_at_risk="727"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="732"/>
                <counts group_id="E3" subjects_affected="43" subjects_at_risk="740"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="580"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="268"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="215"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="311"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Immune thrombocytopenic purpura</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Coeliac disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Duodenal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pancreatic necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Periodontal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Peritoneal adhesions</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Peritoneal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Autoimmune pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Strangulated hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cholelithiasis obstructive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hepatitis cholestatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hepatitis toxic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </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="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Chronic tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Endometritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Enterovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Helicobacter gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Herpes zoster oticus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Ovarian abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="727"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pyelonephritis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Salpingitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Salpingo-oophoritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Urinary bladder abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Uterine infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hepatitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Brain contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cartilage injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Poisoning deliberate</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Postoperative adhesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Skull fractured base</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Traumatic liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alpha 1 foetoprotein abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Nuclear magnetic resonance imaging brain abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Metabolic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ankylosing spondylitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cervical spinal stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Femoroacetabular impingement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </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="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Benign breast neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Benign neoplasm of adrenal gland</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Clear cell renal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Fibroadenoma of breast</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Metastases to chest wall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Papilloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Salivary gland adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Bone sarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis relapse</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="740"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Neurological decompensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Neuromyelitis optica spectrum disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Psychomotor hyperactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Foetal growth abnormality</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Unintended pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Abortion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Abortion missed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Abortion threatened</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Acute psychosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Affective disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Persecutory delusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Personality change due to a general medical condition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Schizophrenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired hydrocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Adnexal torsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Cervix disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Fallopian tube cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Menometrorrhagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Ovarian haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Polycystic ovaries</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </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="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Vasomotor rhinitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalisation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </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="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Embolism arterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="727"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="732"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="727"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="732"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="740"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="580"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="268"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="215"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="311"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</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="262" subjects_at_risk="727"/>
                <counts group_id="E2" subjects_affected="286" subjects_at_risk="732"/>
                <counts group_id="E3" subjects_affected="243" subjects_at_risk="740"/>
                <counts group_id="E4" subjects_affected="102" subjects_at_risk="580"/>
                <counts group_id="E5" subjects_affected="46" subjects_at_risk="268"/>
                <counts group_id="E6" subjects_affected="35" subjects_at_risk="215"/>
                <counts group_id="E7" subjects_affected="43" subjects_at_risk="311"/>
                <counts group_id="E8" subjects_affected="43" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="32" subjects_affected="28" subjects_at_risk="727"/>
                <counts group_id="E2" events="50" subjects_affected="43" subjects_at_risk="732"/>
                <counts group_id="E3" events="35" subjects_affected="30" subjects_at_risk="740"/>
                <counts group_id="E4" events="25" subjects_affected="22" subjects_at_risk="580"/>
                <counts group_id="E5" events="16" subjects_affected="13" subjects_at_risk="268"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="215"/>
                <counts group_id="E7" events="9" subjects_affected="9" subjects_at_risk="311"/>
                <counts group_id="E8" events="12" subjects_affected="9" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="90" subjects_affected="63" subjects_at_risk="727"/>
                <counts group_id="E2" events="86" subjects_affected="60" subjects_at_risk="732"/>
                <counts group_id="E3" events="91" subjects_affected="63" subjects_at_risk="740"/>
                <counts group_id="E4" events="52" subjects_affected="40" subjects_at_risk="580"/>
                <counts group_id="E5" events="20" subjects_affected="14" subjects_at_risk="268"/>
                <counts group_id="E6" events="13" subjects_affected="8" subjects_at_risk="215"/>
                <counts group_id="E7" events="13" subjects_affected="11" subjects_at_risk="311"/>
                <counts group_id="E8" events="13" subjects_affected="11" subjects_at_risk="236"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="54" subjects_affected="32" subjects_at_risk="727"/>
                <counts group_id="E2" events="37" subjects_affected="31" subjects_at_risk="732"/>
                <counts group_id="E3" events="56" subjects_affected="39" subjects_at_risk="740"/>
                <counts group_id="E4" events="19" subjects_affected="14" subjects_at_risk="580"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="268"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="215"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="311"/>
                <counts group_id="E8" events="6" subjects_affected="5" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="727"/>
                <counts group_id="E2" events="43" subjects_affected="38" subjects_at_risk="732"/>
                <counts group_id="E3" events="19" subjects_affected="18" subjects_at_risk="740"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="580"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="268"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="215"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="311"/>
                <counts group_id="E8" events="8" subjects_affected="5" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="74" subjects_affected="54" subjects_at_risk="727"/>
                <counts group_id="E2" events="110" subjects_affected="85" subjects_at_risk="732"/>
                <counts group_id="E3" events="47" subjects_affected="39" subjects_at_risk="740"/>
                <counts group_id="E4" events="14" subjects_affected="12" subjects_at_risk="580"/>
                <counts group_id="E5" events="10" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E6" events="10" subjects_affected="9" subjects_at_risk="215"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="311"/>
                <counts group_id="E8" events="14" subjects_affected="12" subjects_at_risk="236"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="238" subjects_affected="122" subjects_at_risk="727"/>
                <counts group_id="E2" events="227" subjects_affected="131" subjects_at_risk="732"/>
                <counts group_id="E3" events="222" subjects_affected="116" subjects_at_risk="740"/>
                <counts group_id="E4" events="38" subjects_affected="22" subjects_at_risk="580"/>
                <counts group_id="E5" events="14" subjects_affected="8" subjects_at_risk="268"/>
                <counts group_id="E6" events="13" subjects_affected="10" subjects_at_risk="215"/>
                <counts group_id="E7" events="25" subjects_affected="14" subjects_at_risk="311"/>
                <counts group_id="E8" events="15" subjects_affected="10" subjects_at_risk="236"/>
              </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>Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director, Clinical Research</name_or_title>
      <organization>Teva Branded Pharmaceutical Products, R&amp;D Inc.</organization>
      <phone>215-591-3000</phone>
      <email>info.era-clinical@teva.de</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/NCT01707992
org study id: LAQ-MS-305
secondary id: 2012-003647-30
nct id: NCT01707992
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a multinational, multicenter, randomized, double-blind, parallel-group,
      placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and
      tolerability of two doses of oral administration of laquinimod in participants with RRMS. The
      study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months)
      and Period 2, the active treatment period (24 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)
time frame: Baseline to Month 24
description: Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis [MS]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.
measure: Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15
time frame: Baseline, Month 15
description: Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.
measure: Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)
time frame: Baseline to Month 24
description: Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).
measure: Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)
time frame: Baseline to Month 24
description: Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.
measure: Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)
time frame: Baseline to Month 24
description: Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.
measure: Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)
time frame: Baseline up to Month 24
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
measure: Active-Treatment Phase: Number of Participants With AEs
time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
measure: Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities
time frame: Baseline up to Week 24
description: Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (>=) 120 beats per minute (bpm) and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 millimeters of mercury (mmHg) and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.
measure: Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities
time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
description: Clinically significant vital signs abnormalities included: Pulse rate: >=120 bpm and increase from baseline of >=30 bpm, <=45 bpm and decrease from baseline of >=30 bpm; Systolic blood pressure: >=180 mmHg and increase from baseline of >=30 mmHg, <=90 and decrease from baseline of >=30 mmHg; Diastolic blood pressure: >=100 mmHg and increase from baseline of >=20 mmHg, <=50 mmHg and decrease from baseline of >=20 mmHg.
measure: Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
time frame: Baseline, Endpoint (Month 24)
description: ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
measure: Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters
time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)
description: ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.
measure: Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
time frame: Baseline up to Month 24
description: Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter [U/L]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter [mg/L]), pancreatic amylase (in U/L)>=3 * upper limit of normal (ULN); Fibrinogen >=6 grams per liter (gm/L); Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L.
measure: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry
time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
description: Potentially clinically significant serum chemistry abnormalities included: Glucose <=3 and >=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)>=3 * ULN; Fibrinogen >=6 gm/L; Sodium <=130 and >=150 mmol/L; Potassium <=3.2 and >=5.5 mmol/L; Calcium <=1.87 and >=2.75 mmol/L; Phosphate <=0.65 and >=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin >=28 micromols per liter (micromols/L); Creatinine >=117 micromols/L; Albumin <=25 gm/L.
measure: Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values
time frame: Baseline up to Month 24
description: Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5 grams per deciliter (gm/dL) in males and <=10 gm/dL in females; White blood cells (WBCs) count <=2.5 and >=21*10^9 per liter (L); Absolute neutrophil count (ANC) <=1.49*10^9 per L; Platelet count <=100 and >=600*10^9 per L.
measure: Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values
time frame: Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase
description: Potentially clinically significant hematological abnormalities included: Hemoglobin <=11.5, >=20 gm/dL in males, and <=10, >=18.5 gm/dL in females; WBCs count <=2.5 and >=21*10^9 per L; ANC <=1.49*10^9 per L; Platelet count <=100 and >=600*10^9 per L.
arm group label: Placebo-Controlled Phase: Placebo
arm group type: Placebo Comparator
description: Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams [mg]) once daily orally for up to 24 months.
arm group label: Placebo-Controlled Phase: Laquinimod 0.6 mg
arm group type: Experimental
description: Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.
arm group label: Placebo-Controlled Phase: Laquinimod 1.2 mg
arm group type: Experimental
description: Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.
arm group label: Active Treatment Phase: Laquinimod 0.6 mg
arm group type: Experimental
description: Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.
arm group label: Active Treatment Phase: Laquinimod 1.2 mg
arm group type: Experimental
description: Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.
arm group label: Active Treatment Phase: Off Drug
arm group type: No Intervention
description: Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 will continue the active-treatment phase off drug for 24 months.
intervention type: Drug
intervention name: Laquinimod
description: Laquinimod will be administered as per the dose and schedule specified in the respective arms.
arm group label: Active Treatment Phase: Laquinimod 0.6 mg
arm group label: Active Treatment Phase: Laquinimod 1.2 mg
arm group label: Placebo-Controlled Phase: Laquinimod 0.6 mg
arm group label: Placebo-Controlled Phase: Laquinimod 1.2 mg
intervention type: Drug
intervention name: Placebo
description: Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.
arm group label: Active Treatment Phase: Laquinimod 0.6 mg
arm group label: Placebo-Controlled Phase: Laquinimod 0.6 mg
arm group label: Placebo-Controlled Phase: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Teva Medical Expert, MD
role: Study Director
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
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country: Austria
country: Belarus
country: Belgium
country: Bosnia and Herzegovina
country: Bulgaria
country: Canada
country: Croatia
country: Czechia
country: Estonia
country: France
country: Georgia
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Korea, Republic of
country: Latvia
country: Moldova, Republic of
country: Montenegro
country: North Macedonia
country: Poland
country: Romania
country: Russian Federation
country: Serbia
country: Slovakia
country: Spain
country: Ukraine
country: United Kingdom
country: United States
country: Czech Republic
country: Kazakhstan
country: Macedonia, The Former Yugoslav Republic of
country: Mexico
country: Portugal
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Sclerosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 