<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/NCT03041116</url>
  </required_header>
  <id_info>
    <org_study_id>024PKAN15004</org_study_id>
    <nct_id>NCT03041116</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants</brief_title>
  <acronym>PKAN</acronym>
  <official_title>Efficacy, Safety, and Tolerability of Fosmetpantotenate (RE-024), a Phosphopantothenate Replacement Therapy, in Pantothenate Kinase-Associated Neurodegeneration (PKAN) Patients: A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Travere Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Travere Therapeutics, 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 study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement&#xD;
      therapy, was safe and effective in treating participants with PKAN.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was terminated since fosmetpantotenate did not show statistically significant effects&#xD;
    or clinical benefits during the double-blind period.&#xD;
  </why_stopped>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2019</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>Change From Baseline In The Pantothenate Kinase-Associated Neurodegeneration-Activities of Daily Living (PKAN-ADL) Total Score To The End Of The 24-week Double-blind Period</measure>
    <time_frame>Baseline (Day -1), Week 24</time_frame>
    <description>Change from baseline to Week 24 activities of daily living was assessed on the PKAN-ADL scale based on the Unified Parkinson's Disease Rating Scale (UPDRS) Part II. The PKAN-ADL is a validated measure of the participant's ability to complete ADL that are impacted by the diffuse motor manifestations of PKAN. It consists of 12 items related to activities of daily living, including eating, dressing, and walking. Each item has responses ranging from 0-4, with a higher value indicating greater disability in the given activity. To compute the total score, responses are summed across the 12 items. The available range of total scores on the PKAN-ADL scale was from 0 (no ADL affected) to 48 (ADL highly affected). The reported least square mean (LSM) was adjusted for baseline score and age group from the Type III analysis. A decrease in score indicates improvement in symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number Of Participants With At Least 1 (≥1) Treatment-emergent Adverse Event (TEAE) And Treatment-emergent Serious Adverse Event (TESAE) During The 24-week Double-blind Period</measure>
    <time_frame>From Screening until end of Week 24</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence associated with the use of the investigational product (IP; active or placebo) in a participant, without regard to possibility of causal relationship with IP. A serious adverse event (SAE) is an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of death from AE); persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious medical events. The TEAEs in the double-blind period are defined as AEs that are new or are a worsening of an existing condition that begins from day of first dose of IP until day after last dose for double-blind treatment period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline In The UPDRS Part 3 (UPDRS-III) Total Score To The End Of The 24-week Double-blind Period</measure>
    <time_frame>Baseline (Day -1), Week 24</time_frame>
    <description>The UPDRS is a comprehensive assessment of the burden and severity of signs and symptoms of Parkinsonism captured via systematic interview and neurological examination. The UPDRS-III is a standardized neurological examination that evaluates the performance of movements commonly affected in Parkinson's disease, PKAN, and other movement disorders. Part III of the UPDRS consists of 27 items, which correspond to 14 domains related to motor abilities such as tremor, stability, and bradykinesia. Each item has responses ranging from 0-4. To compute the UPDRS-III total score, responses are summed across the 27 items, and accordingly, range from 0-108. For domain totals, responses are summed across all of the items in a given domain (when domain corresponds to multiple items). An increase in score indicates greater disability. The reported LSM was adjusted for baseline score and age group from the Type III analysis.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Pantothenate Kinase-Associated Neurodegeneration</condition>
  <arm_group>
    <arm_group_label>Fosmetpantotenate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered as powder for reconstitution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administered as powder for reconstitution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fosmetpantotenate</intervention_name>
    <description>Daily dosing</description>
    <arm_group_label>Fosmetpantotenate</arm_group_label>
    <other_name>RE-024</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Daily dosing</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The participant had a diagnosis of PKAN as indicated by confirmed mutations in the&#xD;
             pantothenate kinase 2 gene.&#xD;
&#xD;
          2. The participant was male or female aged 6 to 65 years, inclusive.&#xD;
&#xD;
          3. The participant had a score of ≥ 6 on the PKAN-specific activities of daily living&#xD;
             measure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The participant had required regular or intermittent invasive ventilatory support to&#xD;
             maintain vital signs within 24 weeks prior to randomization.&#xD;
&#xD;
          2. The participant had a deep brain stimulation device implanted within 6 months prior to&#xD;
             screening.&#xD;
&#xD;
          3. The participant had taken deferiprone within 30 days prior to screening.&#xD;
&#xD;
          4. The participant was unable to maintain stable doses of allowed concomitant medications&#xD;
             for the first 24 weeks of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Klopstock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum der Universität München</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92697</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Praha 2</city>
        <state>NAP</state>
        <zip>12821</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Montpellier</city>
        <state>Languedoc-Rousillon</state>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Travere Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pkanfortstudy.com</url>
    <description>Study website</description>
  </link>
  <results_reference>
    <citation>Klopstock T, Escolar ML, Marshall RD, Perez-Duenas B, Tuller S, Videnovic A, Greblikas F. The FOsmetpantotenate Replacement Therapy (FORT) randomized, double-blind, Placebo-controlled pivotal trial: Study design and development methodology of a novel primary efficacy outcome in patients with pantothenate kinase-associated neurodegeneration. Clin Trials. 2019 Aug;16(4):410-418. doi: 10.1177/1740774519845673. Epub 2019 May 6.</citation>
    <PMID>31055958</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>December 2, 2020</results_first_submitted>
  <results_first_submitted_qc>December 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 29, 2020</results_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PKAN</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pantothenate Kinase-Associated Neurodegeneration</mesh_term>
    <mesh_term>Nerve Degeneration</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03041116/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03041116/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted in Spain, United States, Canada, Czech Republic, France, Germany, Italy, Norway, and Poland from 17-July-2017 to 23-December-2019. A total of 91 participants were screened, of which 84 participants were randomized in the double blind period, and 78 participants completed the double-blind period.</recruitment_details>
      <pre_assignment_details>The study consisted of a screening period of up to 29 days. All assessments at screening were done as per the schedule of assessments.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fosmetpantotenate</title>
          <description>Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose 3 times daily (TID) from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-blind</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" 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="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received At Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Termination of the study by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Population: any participant who received at least 1 dose of study drug during any period of the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Fosmetpantotenate</title>
          <description>Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="84"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.6" spread="10.61"/>
                    <measurement group_id="B2" value="23.1" spread="13.56"/>
                    <measurement group_id="B3" value="22.9" spread="12.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline In The Pantothenate Kinase-Associated Neurodegeneration-Activities of Daily Living (PKAN-ADL) Total Score To The End Of The 24-week Double-blind Period</title>
        <description>Change from baseline to Week 24 activities of daily living was assessed on the PKAN-ADL scale based on the Unified Parkinson's Disease Rating Scale (UPDRS) Part II. The PKAN-ADL is a validated measure of the participant's ability to complete ADL that are impacted by the diffuse motor manifestations of PKAN. It consists of 12 items related to activities of daily living, including eating, dressing, and walking. Each item has responses ranging from 0-4, with a higher value indicating greater disability in the given activity. To compute the total score, responses are summed across the 12 items. The available range of total scores on the PKAN-ADL scale was from 0 (no ADL affected) to 48 (ADL highly affected). The reported least square mean (LSM) was adjusted for baseline score and age group from the Type III analysis. A decrease in score indicates improvement in symptoms.</description>
        <time_frame>Baseline (Day -1), Week 24</time_frame>
        <population>Double-blind Full Analysis Set: any participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosmetpantotenate</title>
            <description>Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline In The Pantothenate Kinase-Associated Neurodegeneration-Activities of Daily Living (PKAN-ADL) Total Score To The End Of The 24-week Double-blind Period</title>
          <description>Change from baseline to Week 24 activities of daily living was assessed on the PKAN-ADL scale based on the Unified Parkinson's Disease Rating Scale (UPDRS) Part II. The PKAN-ADL is a validated measure of the participant's ability to complete ADL that are impacted by the diffuse motor manifestations of PKAN. It consists of 12 items related to activities of daily living, including eating, dressing, and walking. Each item has responses ranging from 0-4, with a higher value indicating greater disability in the given activity. To compute the total score, responses are summed across the 12 items. The available range of total scores on the PKAN-ADL scale was from 0 (no ADL affected) to 48 (ADL highly affected). The reported least square mean (LSM) was adjusted for baseline score and age group from the Type III analysis. A decrease in score indicates improvement in symptoms.</description>
          <population>Double-blind Full Analysis Set: any participant who received at least 1 dose of study drug.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="0.56"/>
                    <measurement group_id="O2" value="-1.3" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.9115</p_value>
            <p_value_desc>p-value was derived from test of contrast between treatment effects using LSM estimate, adjusted for baseline score and age group from Type III analysis. The test of contrast at Week 24 was considered the primary comparison.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>-0.1</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.8</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.69</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number Of Participants With At Least 1 (≥1) Treatment-emergent Adverse Event (TEAE) And Treatment-emergent Serious Adverse Event (TESAE) During The 24-week Double-blind Period</title>
        <description>An adverse event (AE) is any untoward medical occurrence associated with the use of the investigational product (IP; active or placebo) in a participant, without regard to possibility of causal relationship with IP. A serious adverse event (SAE) is an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of death from AE); persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious medical events. The TEAEs in the double-blind period are defined as AEs that are new or are a worsening of an existing condition that begins from day of first dose of IP until day after last dose for double-blind treatment period.</description>
        <time_frame>From Screening until end of Week 24</time_frame>
        <population>Safety Population: any participant who received at least 1 dose of study drug during any period of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosmetpantotenate</title>
            <description>Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Number Of Participants With At Least 1 (≥1) Treatment-emergent Adverse Event (TEAE) And Treatment-emergent Serious Adverse Event (TESAE) During The 24-week Double-blind Period</title>
          <description>An adverse event (AE) is any untoward medical occurrence associated with the use of the investigational product (IP; active or placebo) in a participant, without regard to possibility of causal relationship with IP. A serious adverse event (SAE) is an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of death from AE); persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious medical events. The TEAEs in the double-blind period are defined as AEs that are new or are a worsening of an existing condition that begins from day of first dose of IP until day after last dose for double-blind treatment period.</description>
          <population>Safety Population: any participant who received at least 1 dose of study drug during any period of the study.</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="41"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≥1 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥1 TESAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline In The UPDRS Part 3 (UPDRS-III) Total Score To The End Of The 24-week Double-blind Period</title>
        <description>The UPDRS is a comprehensive assessment of the burden and severity of signs and symptoms of Parkinsonism captured via systematic interview and neurological examination. The UPDRS-III is a standardized neurological examination that evaluates the performance of movements commonly affected in Parkinson's disease, PKAN, and other movement disorders. Part III of the UPDRS consists of 27 items, which correspond to 14 domains related to motor abilities such as tremor, stability, and bradykinesia. Each item has responses ranging from 0-4. To compute the UPDRS-III total score, responses are summed across the 27 items, and accordingly, range from 0-108. For domain totals, responses are summed across all of the items in a given domain (when domain corresponds to multiple items). An increase in score indicates greater disability. The reported LSM was adjusted for baseline score and age group from the Type III analysis.</description>
        <time_frame>Baseline (Day -1), Week 24</time_frame>
        <population>Double-blind Full Analysis Set: any participant who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Fosmetpantotenate</title>
            <description>Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline In The UPDRS Part 3 (UPDRS-III) Total Score To The End Of The 24-week Double-blind Period</title>
          <description>The UPDRS is a comprehensive assessment of the burden and severity of signs and symptoms of Parkinsonism captured via systematic interview and neurological examination. The UPDRS-III is a standardized neurological examination that evaluates the performance of movements commonly affected in Parkinson's disease, PKAN, and other movement disorders. Part III of the UPDRS consists of 27 items, which correspond to 14 domains related to motor abilities such as tremor, stability, and bradykinesia. Each item has responses ranging from 0-4. To compute the UPDRS-III total score, responses are summed across the 27 items, and accordingly, range from 0-108. For domain totals, responses are summed across all of the items in a given domain (when domain corresponds to multiple items). An increase in score indicates greater disability. The reported LSM was adjusted for baseline score and age group from the Type III analysis.</description>
          <population>Double-blind Full Analysis Set: any participant who received at least 1 dose of study drug.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="5.25"/>
                    <measurement group_id="O2" value="-1.0" spread="6.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=0.1421</p_value>
            <p_value_desc>p-value was derived from the test of contrast between treatment effects using the LSM estimate, adjusted for baseline score and age group from the Type III analysis. The test of contrast at week 24 was considered the primary comparison.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>Difference in LS Mean</param_type>
            <param_value>2</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.38</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>4.78</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Screening until end of treatment (approximately 29 Months)</time_frame>
      <desc>The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fosmetpantotenate</title>
          <description>Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.&#xD;
Includes data over the entire study for those who completed the double-blind period and entered the open-label period.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.&#xD;
Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.&#xD;
Includes data over the entire study for those who completed the double-blind period and entered the open-label period.</description>
        </group>
        <group group_id="E3">
          <title>Fosmetpantotenate During Double-blind Period</title>
          <description>Double-blind Period: each randomized participant received oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Placebo During Double-blind Period</title>
          <description>Double-blind Period: each randomized participant received oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Fosmetpantotenate During Open-label Period</title>
          <description>Open-label Period: at Week 25, all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
        </group>
        <group group_id="E6">
          <title>Placebo During Open-label Period</title>
          <description>Open-label Period: at Week 25, all participants started treatment with fosmetpantotenate according to the placebo-matched dose they were receiving at the end of the double-blind period. No dose escalation was required.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</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="41"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="37"/>
              </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="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Skin Infections</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tonsillitis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Shunt malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="37"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypotonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Fracture treatment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="35" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="41"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="43"/>
                <counts group_id="E5" subjects_affected="25" subjects_at_risk="41"/>
                <counts group_id="E6" subjects_affected="26" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Normochromic normocytic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Left ventricular hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Secondary adrenocortical insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dark circles under eyes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eczema eyelids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Optic atrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E5" events="6" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="12" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="8" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="43"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="13" subjects_affected="7" subjects_at_risk="43"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperchlorhydria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Parotid gland enlargement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tongue disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hypermotility</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="43"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Medical device site inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Medical device site rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Genital candidiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Helminthic infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Stoma site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ear lobe infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Gastrostomy tube site complication</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Face injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Foetal exposure during pregnancy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Traumatic haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Animal scratch</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Eyelid contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Scar</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bacterial test positive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood glucose decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Coagulation time prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Crystal urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Culture throat positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Haemoglobin urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Monocyte count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Monocyte percentage increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nitrite urine present</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urine leukocyte esterase positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Cortisol decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urine leukocyte esterase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Knee deformity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Posture abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="41"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" events="10" subjects_affected="6" subjects_at_risk="41"/>
                <counts group_id="E4" events="9" subjects_affected="8" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="9" subjects_affected="5" subjects_at_risk="43"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oromandibular dystonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Drooling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Muscle spasticity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nystagmus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Opisthotonus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Parkinsonism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperkinesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Product taste abnormal</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Adjustment disorder with depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urine odour abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Apnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Bronchial secretion retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Choking</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="43"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="37"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Institution and Investigator agree that because the study is part of a multi-center study, any publication by the Institution/Investigator of the study results shall not be made before the first multi-center publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated since fosmetpantotenate did not show statistically significant effects or clinical benefits during the double-blind period.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Information Desk</name_or_title>
      <organization>Retrophin, Inc.</organization>
      <phone>+1-877-659-5518</phone>
      <email>medinfo@retrophin.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03041116
org study id: 024PKAN15004
nct id: NCT03041116
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study investigated whether fosmetpantotenate (RE-024), a phosphopantothenate replacement
      therapy, was safe and effective in treating participants with PKAN.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline In The Pantothenate Kinase-Associated Neurodegeneration-Activities of Daily Living (PKAN-ADL) Total Score To The End Of The 24-week Double-blind Period
time frame: Baseline (Day -1), Week 24
description: Change from baseline to Week 24 activities of daily living was assessed on the PKAN-ADL scale based on the Unified Parkinson's Disease Rating Scale (UPDRS) Part II. The PKAN-ADL is a validated measure of the participant's ability to complete ADL that are impacted by the diffuse motor manifestations of PKAN. It consists of 12 items related to activities of daily living, including eating, dressing, and walking. Each item has responses ranging from 0-4, with a higher value indicating greater disability in the given activity. To compute the total score, responses are summed across the 12 items. The available range of total scores on the PKAN-ADL scale was from 0 (no ADL affected) to 48 (ADL highly affected). The reported least square mean (LSM) was adjusted for baseline score and age group from the Type III analysis. A decrease in score indicates improvement in symptoms.
measure: Number Of Participants With At Least 1 (≥1) Treatment-emergent Adverse Event (TEAE) And Treatment-emergent Serious Adverse Event (TESAE) During The 24-week Double-blind Period
time frame: From Screening until end of Week 24
description: An adverse event (AE) is any untoward medical occurrence associated with the use of the investigational product (IP; active or placebo) in a participant, without regard to possibility of causal relationship with IP. A serious adverse event (SAE) is an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of death from AE); persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious medical events. The TEAEs in the double-blind period are defined as AEs that are new or are a worsening of an existing condition that begins from day of first dose of IP until day after last dose for double-blind treatment period.
measure: Absolute Change From Baseline In The UPDRS Part 3 (UPDRS-III) Total Score To The End Of The 24-week Double-blind Period
time frame: Baseline (Day -1), Week 24
description: The UPDRS is a comprehensive assessment of the burden and severity of signs and symptoms of Parkinsonism captured via systematic interview and neurological examination. The UPDRS-III is a standardized neurological examination that evaluates the performance of movements commonly affected in Parkinson's disease, PKAN, and other movement disorders. Part III of the UPDRS consists of 27 items, which correspond to 14 domains related to motor abilities such as tremor, stability, and bradykinesia. Each item has responses ranging from 0-4. To compute the UPDRS-III total score, responses are summed across the 27 items, and accordingly, range from 0-108. For domain totals, responses are summed across all of the items in a given domain (when domain corresponds to multiple items). An increase in score indicates greater disability. The reported LSM was adjusted for baseline score and age group from the Type III analysis.
arm group label: Fosmetpantotenate
arm group type: Experimental
description: Administered as powder for reconstitution.
arm group label: Placebo
arm group type: Placebo Comparator
description: Administered as powder for reconstitution.
intervention type: Drug
intervention name: Fosmetpantotenate
description: Daily dosing
arm group label: Fosmetpantotenate
other name: RE-024
intervention type: Drug
intervention name: Placebo
description: Daily dosing
arm group label: Placebo
criteria: 
gender: All
minimum age: 6 Years
maximum age: 65 Years
healthy volunteers: No
last name: Thomas Klopstock, MD
role: Principal Investigator
affiliation: Klinikum der Universität München
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country: Canada
country: Czechia
country: France
country: Germany
country: Italy
country: Norway
country: Poland
country: Spain
country: United States
url: http://www.pkanfortstudy.com
description: Study website
citation: Klopstock T, Escolar ML, Marshall RD, Perez-Duenas B, Tuller S, Videnovic A, Greblikas F. The FOsmetpantotenate Replacement Therapy (FORT) randomized, double-blind, Placebo-controlled pivotal trial: Study design and development methodology of a novel primary efficacy outcome in patients with pantothenate kinase-associated neurodegeneration. Clin Trials. 2019 Aug;16(4):410-418. doi: 10.1177/1740774519845673. Epub 2019 May 6.
PMID: 31055958
responsible party type: Sponsor
mesh term: Pantothenate Kinase-Associated Neurodegeneration
mesh term: Nerve Degeneration
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated since fosmetpantotenate did not show statistically significant effects or clinical benefits during the double-blind period.
point of contact: 