<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/NCT02214160</url>
  </required_header>
  <id_info>
    <org_study_id>UX007-CL202</org_study_id>
    <secondary_id>2016-000322-19</secondary_id>
    <nct_id>NCT02214160</nct_id>
  </id_info>
  <brief_title>Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Extension Study for Subjects Previously Enrolled in Triheptanoin Studies</brief_title>
  <official_title>An Open-label Long-Term Safety and Efficacy Extension Study in Subjects With Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD) Previously Enrolled in UX007 or Triheptanoin Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ultragenyx Pharmaceutical Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ultragenyx Pharmaceutical Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the long-term safety and efficacy of UX007&#xD;
      in participants with LC-FAOD. The secondary objectives of this study are to evaluate the&#xD;
      effect of UX007 on energy metabolism in LC-FAOD and evaluate the impact of UX007 on clinical&#xD;
      events associated with LC-FAOD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 9, 2014</start_date>
  <completion_date type="Actual">December 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Annualized LC-FAOD Major Clinical Events (MCEs) Rate: 18 Months Pre- and Entire UX007 Period Comparison for UX007-CL201-Rollover Cohort</measure>
    <time_frame>Pre-UX007 treatment period (up to 18 months) and post-UX007 treatment period (up to 2072 days)</time_frame>
    <description>The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualized LC-FAOD MCEs Rate: 18 Months Pre- and Entire UX007 Period Comparison for IST/Other Cohort and Triheptanoin-Naïve Cohort</measure>
    <time_frame>Pre-UX007 treatment period (up to 18 months) and post-UX007 treatment period (up to 2072 days)</time_frame>
    <description>The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs</measure>
    <time_frame>Post-UX007 treatment through the end of treatment (up to 2072 days) plus 30-35 days</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence, whether or not considered drug related. A serious adverse event (SAE) results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability; a congenital anomaly/birth defect; an important medical event. AEs were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (mild=1, moderate=2, severe=3, life-threatening=4, death=5).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Echocardiogram (ECHO) Parameters Over Time: Left Ventricular Mass Index (LVMI)</measure>
    <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Mass (LVM)</measure>
    <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Diameter (LVD)</measure>
    <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Ejection Fraction (LVEF)</measure>
    <time_frame>Baseline, Month 12, Month 18, Month 24, Month 30, Month 36, Month 48, Month 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ECHO Parameters Over Time: LVEF Z-Score (Pediatric Participants)</measure>
    <time_frame>Baseline, Month 12, Month 24, Month 36</time_frame>
    <description>The Z-scores express the deviation (or how far away) the measure is from the mean LVEF based on the size or age of the pediatric participants:&#xD;
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.&#xD;
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.&#xD;
Z-score=+1 indicates it's 1 standard deviation above the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Shortening Fraction (LVSF)</measure>
    <time_frame>Baseline, Month 12, Month 24, Month 30, Month 36, Month 48, Month 60</time_frame>
    <description>Fractional shortening is calculated by measuring the percentage change in left ventricular diameter during systole. A negative value indicates less ventricular/muscular contractility, and a positive value indicates more ventricular/muscular contractility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ECHO Parameters Over Time: LVSF Z-Score (Pediatric Participants)</measure>
    <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
    <description>The Z-scores express the deviation (or how far away) the measure is from the mean LVSF based on the size or age of the pediatric participants:&#xD;
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.&#xD;
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.&#xD;
Z-score=+1 indicates it's 1 standard deviation above the mean.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Duration Rate of All MCEs</measure>
    <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
    <description>The annualized duration rate of LC-FAOD MCEs, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, and defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD. The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Event Rate of Rhabdomyolysis MCEs</measure>
    <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
    <description>The annualized event rate of LC-FAOD major events of skeletal myopathy (rhabdomyolysis), defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Duration Rate of Rhabdomyolysis MCEs</measure>
    <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
    <description>The annualized duration rate of LC-FAOD skeletal myopathy (rhabdomyolysis) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Event Rate of Cardiomyopathy MCEs</measure>
    <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
    <description>The annualized event rate of LC-FAOD major events inclusive of cardiomyopathy events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Duration Rate of Cardiomyopathy MCEs</measure>
    <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
    <description>The annualized duration rate of LC-FAOD cardiomyopathy MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Event Rate of Hypoglycemic MCEs</measure>
    <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
    <description>The annualized event rate of LC-FAOD major events of hepatic (hypoglycemia) events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annualized Duration Rate of Hypoglycemic MCEs</measure>
    <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
    <description>The annualized duration rate of LC-FAOD hepatic (hypoglycemia) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Carnitine Palmitoyltransferase (CPT I or CPT II) Deficiency</condition>
  <condition>Very Long Chain Acyl-CoA Dehydrogenase (VLCAD) Deficiency</condition>
  <condition>Long-chain 3-hydroxy-acyl-CoA Dehydrogenase (LCHAD) Deficiency</condition>
  <condition>Trifunctional Protein (TFP) Deficiency</condition>
  <condition>Carnitine-acylcarnitine Translocase (CACT) Deficiency</condition>
  <arm_group>
    <arm_group_label>UX007</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants previously treated with UX007 or treatment-naive participants will begin or continue treatment with daily open-label UX007 while maintaining their other dietary restrictions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>UX007</intervention_name>
    <description>Administered orally (PO) with food or by gastrostomy tube, at the target dose range of 25-35% of total calories.</description>
    <arm_group_label>UX007</arm_group_label>
    <other_name>Triheptanoin</other_name>
    <other_name>C7</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 6 months of age or older&#xD;
&#xD;
          2. Prior participation in a clinical study assessing UX007/triheptanoin treatment for LC&#xD;
             FAOD. Study Sponsors/Collaborators include: Oregon Health &amp; Science University,&#xD;
             University of Pittsburgh, and Ultragenyx Pharmaceutical (ClinicalTrials.gov&#xD;
             Identifiers: NCT01379625, NCT01461304, and NCT01886378). Patients who received&#xD;
             UX007/triheptanoin treatment as part of other clinical studies; investigator sponsored&#xD;
             trials (IST); expanded access/compassionate use treatment programs; or patients who&#xD;
             are treatment naïve (i.e., naïve to both UX007 and food-grade triheptanoin), have&#xD;
             failed conventional therapy and, in the opinion of the Investigator and Sponsor, have&#xD;
             documented clear unmet need, may also be eligible at the discretion of the Sponsor&#xD;
&#xD;
          3. Confirmed diagnosis of LC-FAOD including: CPT I or CPT II deficiency, VLCAD&#xD;
             deficiency, LCHAD deficiency, TFP deficiency, or CACT deficiency. Information on&#xD;
             diagnosis will be obtained from medical records and should include confirmed diagnosis&#xD;
             by results of acylcarnitine profiles, fatty acid oxidation probe studies in cultured&#xD;
             fibroblasts, and/or mutation analysis&#xD;
&#xD;
          4. Willing and able to complete all aspects of the study through the end of the study,&#xD;
             including visits and tests, documentation of symptoms and diet, and administration of&#xD;
             study medications. If a minor, have a caregiver(s) willing and able to assist in all&#xD;
             applicable study requirements&#xD;
&#xD;
          5. Provide written informed consent (subjects aged ≥ 18 years), or provide written assent&#xD;
             (where appropriate) and have a legally authorized representative willing and able to&#xD;
             provide written informed consent, after the nature of the study has been explained and&#xD;
             prior to any research-related procedures.&#xD;
&#xD;
          6. Females of child-bearing potential must have a negative urine pregnancy test at&#xD;
             Baseline and be willing to have additional pregnancy tests during the study. Females&#xD;
             considered not of child-bearing potential include those who have not experienced&#xD;
             menarche, are post-menopausal (defined as having no menses for at least 12 months&#xD;
             without an alternative medical cause), or are permanently sterile due to total&#xD;
             hysterectomy, bilateral salpingectomy, or bilateral oophorectomy&#xD;
&#xD;
          7. Participants of child-bearing potential or fertile males with partners of&#xD;
             child-bearing potential who are sexually active must consent to use a highly effective&#xD;
             method of contraception as determined by the Investigator from the period following&#xD;
             the signing of the informed consent through 30 days after last dose of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of medium-chain acyl coenzyme A dehydrogenase (MCAD) deficiency, short- or&#xD;
             medium-chain FAOD, ketone body metabolism defect, propionic acidemia or methylmalonic&#xD;
             acidemia&#xD;
&#xD;
          2. Patient qualifies for any other clinical trial designed to progressively evaluate the&#xD;
             safety and efficacy of triheptanoin in LC-FAOD&#xD;
&#xD;
          3. Any known hypersensitivity to triheptanoin that, in the judgment of the Investigator,&#xD;
             places the subject at increased risk for adverse effects&#xD;
&#xD;
          4. Pregnant and/or breastfeeding an infant at Screening or planning to become pregnant&#xD;
             (self or partner) at any time during the study&#xD;
&#xD;
          5. Have any co-morbid conditions, including unstable major organ-system disease(s) that&#xD;
             in the opinion of the Investigator, places the subject at increased risk of&#xD;
             complications, interferes with study participation or compliance, or confounds study&#xD;
             objectives, or unwilling to discontinue prohibited medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ultragenyx Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's National Health System</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital for Neurology and Neurosurgery</name>
      <address>
        <city>London</city>
        <zip>WC1N 3BP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Vockley J, Burton B, Berry G, Longo N, Phillips J, Sanchez-Valle A, Chapman K, Tanpaiboon P, Grunewald S, Murphy E, Lu X, Cataldo J. Effects of triheptanoin (UX007) in patients with long-chain fatty acid oxidation disorders: Results from an open-label, long-term extension study. J Inherit Metab Dis. 2021 Jan;44(1):253-263. doi: 10.1002/jimd.12313. Epub 2020 Sep 14.</citation>
    <PMID>32885845</PMID>
  </reference>
  <reference>
    <citation>Vockley J, Burton BK, Berry G, Longo N, Phillips J, Sanchez-Valle A, Chapman KA, Tanpaiboon P, Grunewald S, Murphy E, Lu X, Rahman S, Ray K, Reineking B, Pisani L, Ramirez AN. Triheptanoin for the treatment of long-chain fatty acid oxidation disorders: Final results of an open-label, long-term extension study. J Inherit Metab Dis. 2023 Jun 5. doi: 10.1002/jimd.12640. Online ahead of print.</citation>
    <PMID>37276053</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>October 11, 2021</results_first_submitted>
  <results_first_submitted_qc>November 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">December 8, 2021</results_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Long-Chain Fatty Acid Oxidation Disorders (LC-FAOD)</keyword>
  <keyword>carnitine palmitoyltransferase (CPT I or CPT II) deficiency</keyword>
  <keyword>very long chain acyl-CoA dehydrogenase (VLCAD) deficiency</keyword>
  <keyword>long-chain 3-hydroxy-acyl-CoA dehydrogenase (LCHAD) deficiency</keyword>
  <keyword>trifunctional protein (TFP) deficiency</keyword>
  <keyword>carnitine-acylcarnitine translocase (CACT) deficiency</keyword>
  <keyword>Triheptanoin</keyword>
  <keyword>UX007</keyword>
  <keyword>C7</keyword>
  <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>October 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT02214160/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>December 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/60/NCT02214160/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>UX007-CL201-Rollover Cohort</title>
          <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="P2">
          <title>IST/Other Cohort</title>
          <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="P3">
          <title>Triheptanoin-Naïve Cohort</title>
          <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="29"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Non-Compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>UX007-CL201-Rollover Cohort</title>
          <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="B2">
          <title>IST/Other Cohort</title>
          <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="B3">
          <title>Triheptanoin-Naïve Cohort</title>
          <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="33"/>
            <count group_id="B4" value="94"/>
          </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="13.16" spread="14.310"/>
                    <measurement group_id="B2" value="17.69" spread="14.490"/>
                    <measurement group_id="B3" value="9.33" spread="9.745"/>
                    <measurement group_id="B4" value="13.60" spread="13.333"/>
                  </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="10"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="49"/>
                  </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="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other, Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Annualized LC-FAOD Major Clinical Events (MCEs) Rate: 18 Months Pre- and Entire UX007 Period Comparison for UX007-CL201-Rollover Cohort</title>
        <description>The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25</description>
        <time_frame>Pre-UX007 treatment period (up to 18 months) and post-UX007 treatment period (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized LC-FAOD Major Clinical Events (MCEs) Rate: 18 Months Pre- and Entire UX007 Period Comparison for UX007-CL201-Rollover Cohort</title>
          <description>The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>events/year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-UX007 Period</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UX007 Treatment Period</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0347</p_value>
            <method>Paired T-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annualized LC-FAOD MCEs Rate: 18 Months Pre- and Entire UX007 Period Comparison for IST/Other Cohort and Triheptanoin-Naïve Cohort</title>
        <description>The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25</description>
        <time_frame>Pre-UX007 treatment period (up to 18 months) and post-UX007 treatment period (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Per protocol, pre-UX007 MCE data was not collected in the IST/Other Cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized LC-FAOD MCEs Rate: 18 Months Pre- and Entire UX007 Period Comparison for IST/Other Cohort and Triheptanoin-Naïve Cohort</title>
          <description>The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Per protocol, pre-UX007 MCE data was not collected in the IST/Other Cohort.</population>
          <units>events/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-UX007 Period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.00" lower_limit="0.67" upper_limit="3.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>UX007 Treatment Period</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="37"/>
                    <count group_id="O2" value="33"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.57" lower_limit="0.0" upper_limit="1.67"/>
                    <measurement group_id="O2" value="0.28" lower_limit="0.00" upper_limit="1.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0343</p_value>
            <method>Wilcoxon Signed Rank Test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence, whether or not considered drug related. A serious adverse event (SAE) results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability; a congenital anomaly/birth defect; an important medical event. AEs were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (mild=1, moderate=2, severe=3, life-threatening=4, death=5).</description>
        <time_frame>Post-UX007 treatment through the end of treatment (up to 2072 days) plus 30-35 days</time_frame>
        <population>Safety Analysis Set: participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence, whether or not considered drug related. A serious adverse event (SAE) results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability; a congenital anomaly/birth defect; an important medical event. AEs were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (mild=1, moderate=2, severe=3, life-threatening=4, death=5).</description>
          <population>Safety Analysis Set: participants who received at least 1 dose of study drug.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;= 1 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Related Gastrointestinal (GI) TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 4 TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Related Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs Leading to Treatment Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs Leading to Study Discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs Leading to Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Echocardiogram (ECHO) Parameters Over Time: Left Ventricular Mass Index (LVMI)</title>
        <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Echocardiogram (ECHO) Parameters Over Time: Left Ventricular Mass Index (LVMI)</title>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
          <units>g/m</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.27" spread="21.433"/>
                    <measurement group_id="O2" value="4.55" spread="21.903"/>
                    <measurement group_id="O3" value="-9.06" spread="29.965"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.73" spread="23.711"/>
                    <measurement group_id="O2" value="-0.37" spread="18.132"/>
                    <measurement group_id="O3" value="1.00" spread="39.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.75" spread="28.933"/>
                    <measurement group_id="O2" value="1.23" spread="19.488"/>
                    <measurement group_id="O3" value="12.33" spread="38.831"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.33" spread="29.263"/>
                    <measurement group_id="O2" value="-1.04" spread="21.900"/>
                    <measurement group_id="O3" value="-9.67" spread="36.529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8.83" spread="25.639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Mass (LVM)</title>
        <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.&#xD;
-</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Mass (LVM)</title>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
          <units>g</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.50" spread="29.374"/>
                    <measurement group_id="O2" value="12.58" spread="22.648"/>
                    <measurement group_id="O3" value="-0.75" spread="25.935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.71" spread="27.034"/>
                    <measurement group_id="O2" value="5.61" spread="34.465"/>
                    <measurement group_id="O3" value="3.25" spread="38.833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.21" spread="30.355"/>
                    <measurement group_id="O2" value="16.36" spread="36.898"/>
                    <measurement group_id="O3" value="15.75" spread="48.922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.25" spread="12.842"/>
                    <measurement group_id="O2" value="19.72" spread="42.645"/>
                    <measurement group_id="O3" value="10.25" spread="52.753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="46.29" spread="19.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Diameter (LVD)</title>
        <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Diameter (LVD)</title>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.19" spread="9.138"/>
                    <measurement group_id="O2" value="2.38" spread="8.719"/>
                    <measurement group_id="O3" value="1.57" spread="4.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.26" spread="11.158"/>
                    <measurement group_id="O2" value="3.00" spread="8.535"/>
                    <measurement group_id="O3" value="0.67" spread="4.755"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="13.174"/>
                    <measurement group_id="O2" value="3.23" spread="8.883"/>
                    <measurement group_id="O3" value="4.78" spread="5.094"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.88" spread="17.264"/>
                    <measurement group_id="O2" value="3.82" spread="9.115"/>
                    <measurement group_id="O3" value="2.60" spread="5.177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="40.29" spread="5.407"/>
                    <measurement group_id="O3" value="50.00" spread="NA">1 participant at this time point</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Ejection Fraction (LVEF)</title>
        <time_frame>Baseline, Month 12, Month 18, Month 24, Month 30, Month 36, Month 48, Month 60</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Ejection Fraction (LVEF)</title>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
          <units>percent of blood ejected during systole</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="7.602"/>
                    <measurement group_id="O2" value="1.32" spread="7.254"/>
                    <measurement group_id="O3" value="0.71" spread="6.474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0.00" spread="NA">1 participant at this time point</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.86" spread="9.062"/>
                    <measurement group_id="O2" value="0.24" spread="8.875"/>
                    <measurement group_id="O3" value="2.31" spread="8.400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="NA">1 participant at this time point</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.10" spread="7.259"/>
                    <measurement group_id="O2" value="-1.92" spread="5.986"/>
                    <measurement group_id="O3" value="3.44" spread="7.601"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="3.445"/>
                    <measurement group_id="O2" value="-1.57" spread="7.464"/>
                    <measurement group_id="O3" value="1.60" spread="5.459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-5.00" spread="7.394"/>
                    <measurement group_id="O3" value="1.00" spread="NA">1 participant at this time point</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ECHO Parameters Over Time: LVEF Z-Score (Pediatric Participants)</title>
        <description>The Z-scores express the deviation (or how far away) the measure is from the mean LVEF based on the size or age of the pediatric participants:&#xD;
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.&#xD;
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.&#xD;
Z-score=+1 indicates it's 1 standard deviation above the mean.</description>
        <time_frame>Baseline, Month 12, Month 24, Month 36</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Pediatric participants with a value at baseline and given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ECHO Parameters Over Time: LVEF Z-Score (Pediatric Participants)</title>
          <description>The Z-scores express the deviation (or how far away) the measure is from the mean LVEF based on the size or age of the pediatric participants:&#xD;
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.&#xD;
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.&#xD;
Z-score=+1 indicates it's 1 standard deviation above the mean.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Pediatric participants with a value at baseline and given time point.</population>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="1.229"/>
                    <measurement group_id="O2" value="1.84" spread="NA">1 participant at this time point</measurement>
                    <measurement group_id="O3" value="0.21" spread="1.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.05" spread="1.469"/>
                    <measurement group_id="O2" value="2.28" spread="NA">1 participant at this time point</measurement>
                    <measurement group_id="O3" value="0.72" spread="1.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.52" spread="NA">1 participant at this time point</measurement>
                    <measurement group_id="O3" value="-0.66" spread="NA">1 participant at this time point</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Shortening Fraction (LVSF)</title>
        <description>Fractional shortening is calculated by measuring the percentage change in left ventricular diameter during systole. A negative value indicates less ventricular/muscular contractility, and a positive value indicates more ventricular/muscular contractility.</description>
        <time_frame>Baseline, Month 12, Month 24, Month 30, Month 36, Month 48, Month 60</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ECHO Parameters Over Time: Left Ventricular Shortening Fraction (LVSF)</title>
          <description>Fractional shortening is calculated by measuring the percentage change in left ventricular diameter during systole. A negative value indicates less ventricular/muscular contractility, and a positive value indicates more ventricular/muscular contractility.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Participants with a value at baseline and given time point.</population>
          <units>% change in left ventricular diameter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.30" spread="5.564"/>
                    <measurement group_id="O2" value="-0.91" spread="6.468"/>
                    <measurement group_id="O3" value="-1.48" spread="5.904"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.90" spread="6.052"/>
                    <measurement group_id="O2" value="1.03" spread="6.242"/>
                    <measurement group_id="O3" value="-1.36" spread="7.967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.00" spread="NA">1 participant at this time point</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="6.086"/>
                    <measurement group_id="O2" value="0.25" spread="4.502"/>
                    <measurement group_id="O3" value="1.11" spread="5.395"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="4.320"/>
                    <measurement group_id="O2" value="0.52" spread="4.501"/>
                    <measurement group_id="O3" value="-0.60" spread="6.269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.57" spread="4.392"/>
                    <measurement group_id="O3" value="0.00" spread="NA">1 participant at this time point</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ECHO Parameters Over Time: LVSF Z-Score (Pediatric Participants)</title>
        <description>The Z-scores express the deviation (or how far away) the measure is from the mean LVSF based on the size or age of the pediatric participants:&#xD;
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.&#xD;
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.&#xD;
Z-score=+1 indicates it's 1 standard deviation above the mean.</description>
        <time_frame>Baseline, Month 12, Month 24, Month 36, Month 48, Month 60</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Pediatric participants with a value at baseline and given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ECHO Parameters Over Time: LVSF Z-Score (Pediatric Participants)</title>
          <description>The Z-scores express the deviation (or how far away) the measure is from the mean LVSF based on the size or age of the pediatric participants:&#xD;
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.&#xD;
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.&#xD;
Z-score=+1 indicates it's 1 standard deviation above the mean.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment. Pediatric participants with a value at baseline and given time point.</population>
          <units>Z-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="1.659"/>
                    <measurement group_id="O2" value="0.25" spread="1.315"/>
                    <measurement group_id="O3" value="-0.38" spread="1.597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="2.255"/>
                    <measurement group_id="O2" value="0.30" spread="1.607"/>
                    <measurement group_id="O3" value="0.13" spread="2.119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="1.729"/>
                    <measurement group_id="O2" value="0.13" spread="1.115"/>
                    <measurement group_id="O3" value="0.58" spread="1.943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.316"/>
                    <measurement group_id="O2" value="0.24" spread="1.464"/>
                    <measurement group_id="O3" value="0.10" spread="1.888"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Month 60</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.45" spread="0.834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Duration Rate of All MCEs</title>
        <description>The annualized duration rate of LC-FAOD MCEs, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, and defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD. The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
        <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Duration Rate of All MCEs</title>
          <description>The annualized duration rate of LC-FAOD MCEs, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, and defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD. The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>days/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.123" lower_limit="0.000" upper_limit="9.766"/>
                    <measurement group_id="O2" value="2.487" lower_limit="0.000" upper_limit="6.968"/>
                    <measurement group_id="O3" value="0.796" lower_limit="0.000" upper_limit="5.484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Event Rate of Rhabdomyolysis MCEs</title>
        <description>The annualized event rate of LC-FAOD major events of skeletal myopathy (rhabdomyolysis), defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
        <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Event Rate of Rhabdomyolysis MCEs</title>
          <description>The annualized event rate of LC-FAOD major events of skeletal myopathy (rhabdomyolysis), defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>events/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.352" lower_limit="0.000" upper_limit="1.472"/>
                    <measurement group_id="O2" value="0.574" lower_limit="0.000" upper_limit="1.673"/>
                    <measurement group_id="O3" value="0.281" lower_limit="0.000" upper_limit="1.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Duration Rate of Rhabdomyolysis MCEs</title>
        <description>The annualized duration rate of LC-FAOD skeletal myopathy (rhabdomyolysis) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
        <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Duration Rate of Rhabdomyolysis MCEs</title>
          <description>The annualized duration rate of LC-FAOD skeletal myopathy (rhabdomyolysis) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>days/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.123" lower_limit="0.000" upper_limit="6.969"/>
                    <measurement group_id="O2" value="2.487" lower_limit="0.000" upper_limit="6.948"/>
                    <measurement group_id="O3" value="0.448" lower_limit="0.000" upper_limit="5.398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Event Rate of Cardiomyopathy MCEs</title>
        <description>The annualized event rate of LC-FAOD major events inclusive of cardiomyopathy events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
        <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Event Rate of Cardiomyopathy MCEs</title>
          <description>The annualized event rate of LC-FAOD major events inclusive of cardiomyopathy events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>event/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.000" upper_limit="0.120"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Duration Rate of Cardiomyopathy MCEs</title>
        <description>The annualized duration rate of LC-FAOD cardiomyopathy MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25</description>
        <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Duration Rate of Cardiomyopathy MCEs</title>
          <description>The annualized duration rate of LC-FAOD cardiomyopathy MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>days/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.000" upper_limit="0.174"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Event Rate of Hypoglycemic MCEs</title>
        <description>The annualized event rate of LC-FAOD major events of hepatic (hypoglycemia) events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
        <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Event Rate of Hypoglycemic MCEs</title>
          <description>The annualized event rate of LC-FAOD major events of hepatic (hypoglycemia) events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>events/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annualized Duration Rate of Hypoglycemic MCEs</title>
        <description>The annualized duration rate of LC-FAOD hepatic (hypoglycemia) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
        <time_frame>Post-UX007 treatment through the end of the study (up to 2072 days)</time_frame>
        <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>UX007-CL201-Rollover Cohort</title>
            <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O2">
            <title>IST/Other Cohort</title>
            <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
          <group group_id="O3">
            <title>Triheptanoin-Naïve Cohort</title>
            <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Duration Rate of Hypoglycemic MCEs</title>
          <description>The annualized duration rate of LC-FAOD hepatic (hypoglycemia) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.&#xD;
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.</description>
          <population>Full Analysis Set: all participants enrolled who had at least 1 post-baseline efficacy assessment.</population>
          <units>days/year</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O2" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                    <measurement group_id="O3" value="0.000" lower_limit="0.000" upper_limit="0.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Post-UX007 treatment through the end of treatment (up to 2072 days) plus 30-35 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>UX007-CL201-Rollover Cohort</title>
          <description>Participants who participated in the UX007-CL201 study (NCT01886378) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="E2">
          <title>IST/Other Cohort</title>
          <description>Participants who were previously treated with UX007/triheptanoin (including food-grade triheptanoin) in an investigator sponsored trial (IST) or another UX007/triheptanoin study receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="E3">
          <title>Triheptanoin-Naïve Cohort</title>
          <description>Participants who are UX007 treatment-naïve (i.e., naïve to both UX007 and food-grade triheptanoin), or who had failed conventional therapy (including those who participated in UX007-CL201 study previously but were off UX007 for more than 2 years preceding enrollment into CL202) receive UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</description>
        </group>
        <group group_id="E4">
          <title>All Participants</title>
          <description>All participants received UX007, administered orally with food or by gastronomy tube (usually 4 times per day: breakfast, lunch, dinner, and before bed), at the target dose range of 25-35% of total calories.</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="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="70" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ARRHYTHMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CARDIAC FAILURE ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CARDIOMYOPATHY</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CARDIOPULMONARY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CONGESTIVE CARDIOMYOPATHY</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>LEFT VENTRICULAR HYPERTROPHY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>LONG QT SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MYOCARDITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CHRONIC GASTRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTRIC ULCER HAEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROOESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ILEUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PANCREATITIS ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RECTAL POLYP</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>STEATORRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>VOLVULUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CLOSTRIDIUM DIFFICILE INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CROUP INFECTIOUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DEVICE RELATED INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DIVERTICULITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTRITIS VIRAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS VIRAL</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL VIRAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HERPES SIMPLEX</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA BACTERAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>KLEBSIELLA INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ORAL CANDIDIASIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PARAINFLUENZAE VIRUS INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS STREPTOCOCCAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PNEUMONIA STAPHYLOCOCCAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PYELONEPHRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RESPIRATORY TRACT INFECTION VIRAL</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RHINOVIRUS INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL BACTERAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>TONSILLITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>TRACHEITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>VIRAL CARDIOMYOPATHY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>OVERDOSE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PROCEDURAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>AMMONIA INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>BLOOD CREATINE PHOSPHOKINASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>BRAIN NATRIURETIC PEPTIDE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>INFLUENZA A VIRUS TEST POSITIVE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>TRANSAMINASES INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>ACIDOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPERAMMONAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOPHAGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>METABOLIC DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>JOINT INSTABILITY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>OSTEOPOROSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RHABDOMYOLYSIS</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="54" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>SCOLIOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>PLEOMORPHIC ADENOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMORRHAGE INTRACRANIAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ISCHAEMIC STROKE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>LETHARGY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MIGRAINE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>NEUROPATHY PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>POLYNEUROPATHY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>LISTLESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RENAL FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ATELECTASIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CHRONIC RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PULMONARY OEDEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISTRESS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>TONSILLAR HYPERTROPHY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>ELECTIVE PROCEDURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HEART TRANSPLANT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMODYNAMIC INSTABILITY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>POOR VENOUS ACCESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="24" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="90" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>CARDIOMYOPATHY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PALPITATIONS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>EAR PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MOTION SICKNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>ASTIGMATISM</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPERMETROPIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MYOPIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DENTAL CARIES</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="44" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROOESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>TOOTH IMPACTED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>TOOTHACHE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>INFUSION SITE EXTRAVASATION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>DRUG HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPERSENSITIVITY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>SEASONAL ALLERGY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CROUP INFECTIOUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>EAR INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROENTERITIS VIRAL</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL VIRAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>INFECTIOUS MONONUCLEOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>LOWER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>OTITIS EXTERNA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>OTITIS MEDIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PARAINFLUENZAE VIRUS INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS STREPTOCOCCAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>POST PROCEDURAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RHINITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="47" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>VIRAL UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="33" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CONTUSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HAND FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>LIGAMENT SPRAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PROCEDURAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>STOMA SITE HYPERGRANULATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD CHOLESTEROL INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>BLOOD CREATINE PHOSPHOKINASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>CARNITINE DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ELECTROENCEPHALOGRAM ABNORMAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>INFLUENZA A VIRUS TEST POSITIVE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>WEIGHT INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>ABNORMAL WEIGHT GAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>FLUID OVERLOAD</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOCALCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOPHAGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>OBESITY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MUSCULAR WEAKNESS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RHABDOMYOLYSIS</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="34" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOTONIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>LETHARGY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>MIGRAINE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>NEUROPATHY PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ATTENTION DEFICIT/HYPERACTIVITY DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>ENURESIS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ATELECTASIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>OROPHARYNGEAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RESPIRATORY DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RHINORRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ACNE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DERMATITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DERMATITIS CONTACT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>DERMATITIS DIAPER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>POOR VENOUS ACCESS</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="94"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Information</name_or_title>
      <organization>Ultragenyx Pharmaceutical Inc</organization>
      <phone>1-888-756-8657</phone>
      <email>medinfo@ultragenyx.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/NCT02214160
org study id: UX007-CL202
secondary id: 2016-000322-19
nct id: NCT02214160
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to evaluate the long-term safety and efficacy of UX007
      in participants with LC-FAOD. The secondary objectives of this study are to evaluate the
      effect of UX007 on energy metabolism in LC-FAOD and evaluate the impact of UX007 on clinical
      events associated with LC-FAOD.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Annualized LC-FAOD Major Clinical Events (MCEs) Rate: 18 Months Pre- and Entire UX007 Period Comparison for UX007-CL201-Rollover Cohort
time frame: Pre-UX007 treatment period (up to 18 months) and post-UX007 treatment period (up to 2072 days)
description: The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25
measure: Annualized LC-FAOD MCEs Rate: 18 Months Pre- and Entire UX007 Period Comparison for IST/Other Cohort and Triheptanoin-Naïve Cohort
time frame: Pre-UX007 treatment period (up to 18 months) and post-UX007 treatment period (up to 2072 days)
description: The annualized LC-FAOD MCE rate, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, defined as any visit to the emergency room (ER)/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious TEAEs
time frame: Post-UX007 treatment through the end of treatment (up to 2072 days) plus 30-35 days
description: An adverse event (AE) was defined as any untoward medical occurrence, whether or not considered drug related. A serious adverse event (SAE) results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or disability; a congenital anomaly/birth defect; an important medical event. AEs were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (mild=1, moderate=2, severe=3, life-threatening=4, death=5).
measure: Change From Baseline in Echocardiogram (ECHO) Parameters Over Time: Left Ventricular Mass Index (LVMI)
time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60
measure: Change From Baseline in ECHO Parameters Over Time: Left Ventricular Mass (LVM)
time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60
measure: Change From Baseline in ECHO Parameters Over Time: Left Ventricular Diameter (LVD)
time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60
measure: Change From Baseline in ECHO Parameters Over Time: Left Ventricular Ejection Fraction (LVEF)
time frame: Baseline, Month 12, Month 18, Month 24, Month 30, Month 36, Month 48, Month 60
measure: Change From Baseline in ECHO Parameters Over Time: LVEF Z-Score (Pediatric Participants)
time frame: Baseline, Month 12, Month 24, Month 36
description: The Z-scores express the deviation (or how far away) the measure is from the mean LVEF based on the size or age of the pediatric participants:
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.
Z-score=+1 indicates it's 1 standard deviation above the mean.
measure: Change From Baseline in ECHO Parameters Over Time: Left Ventricular Shortening Fraction (LVSF)
time frame: Baseline, Month 12, Month 24, Month 30, Month 36, Month 48, Month 60
description: Fractional shortening is calculated by measuring the percentage change in left ventricular diameter during systole. A negative value indicates less ventricular/muscular contractility, and a positive value indicates more ventricular/muscular contractility.
measure: Change From Baseline in ECHO Parameters Over Time: LVSF Z-Score (Pediatric Participants)
time frame: Baseline, Month 12, Month 24, Month 36, Month 48, Month 60
description: The Z-scores express the deviation (or how far away) the measure is from the mean LVSF based on the size or age of the pediatric participants:
Z-score=0 indicates the participant is exactly the same as the mean of the healthy general population.
Z-score=-1 indicates it's 1 standard deviation below the mean of the healthy population.
Z-score=+1 indicates it's 1 standard deviation above the mean.
measure: Annualized Duration Rate of All MCEs
time frame: Post-UX007 treatment through the end of the study (up to 2072 days)
description: The annualized duration rate of LC-FAOD MCEs, inclusive of skeletal myopathy (rhabdomyolysis), hepatic (hypoglycemia) and cardiomyopathy events, and defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD. The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.
measure: Annualized Event Rate of Rhabdomyolysis MCEs
time frame: Post-UX007 treatment through the end of the study (up to 2072 days)
description: The annualized event rate of LC-FAOD major events of skeletal myopathy (rhabdomyolysis), defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.
measure: Annualized Duration Rate of Rhabdomyolysis MCEs
time frame: Post-UX007 treatment through the end of the study (up to 2072 days)
description: The annualized duration rate of LC-FAOD skeletal myopathy (rhabdomyolysis) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.
measure: Annualized Event Rate of Cardiomyopathy MCEs
time frame: Post-UX007 treatment through the end of the study (up to 2072 days)
description: The annualized event rate of LC-FAOD major events inclusive of cardiomyopathy events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.
measure: Annualized Duration Rate of Cardiomyopathy MCEs
time frame: Post-UX007 treatment through the end of the study (up to 2072 days)
description: The annualized duration rate of LC-FAOD cardiomyopathy MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25
measure: Annualized Event Rate of Hypoglycemic MCEs
time frame: Post-UX007 treatment through the end of the study (up to 2072 days)
description: The annualized event rate of LC-FAOD major events of hepatic (hypoglycemia) events, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized event rate was calculated at the number of events divided by the duration of data collection period in days/365.25.
measure: Annualized Duration Rate of Hypoglycemic MCEs
time frame: Post-UX007 treatment through the end of the study (up to 2072 days)
description: The annualized duration rate of LC-FAOD hepatic (hypoglycemia) MCEs, defined as any visit to the ER/acute care, hospitalization, emergency intervention (i.e. any unscheduled administration of therapeutics at home or in the clinic), or any similar event whether caused primarily by LC-FAOD or by an intercurrent illness complicated by LC-FAOD.
The annualized duration rate is calculated as the total duration (days) of events divided by the duration of data collection period in days/365.25.
arm group label: UX007
arm group type: Experimental
description: Participants previously treated with UX007 or treatment-naive participants will begin or continue treatment with daily open-label UX007 while maintaining their other dietary restrictions.
intervention type: Drug
intervention name: UX007
description: Administered orally (PO) with food or by gastrostomy tube, at the target dose range of 25-35% of total calories.
arm group label: UX007
other name: Triheptanoin
other name: C7
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Ultragenyx Inc.
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country: United Kingdom
country: United States
citation: Vockley J, Burton B, Berry G, Longo N, Phillips J, Sanchez-Valle A, Chapman K, Tanpaiboon P, Grunewald S, Murphy E, Lu X, Cataldo J. Effects of triheptanoin (UX007) in patients with long-chain fatty acid oxidation disorders: Results from an open-label, long-term extension study. J Inherit Metab Dis. 2021 Jan;44(1):253-263. doi: 10.1002/jimd.12313. Epub 2020 Sep 14.
PMID: 32885845
citation: Vockley J, Burton BK, Berry G, Longo N, Phillips J, Sanchez-Valle A, Chapman KA, Tanpaiboon P, Grunewald S, Murphy E, Lu X, Rahman S, Ray K, Reineking B, Pisani L, Ramirez AN. Triheptanoin for the treatment of long-chain fatty acid oxidation disorders: Final results of an open-label, long-term extension study. J Inherit Metab Dis. 2023 Jun 5. doi: 10.1002/jimd.12640. Online ahead of print.
PMID: 37276053
responsible party type: Sponsor
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