<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT01713582</url>
  </required_header>
  <id_info>
    <org_study_id>8628-001</org_study_id>
    <secondary_id>OTX015_104</secondary_id>
    <secondary_id>2012-003380-22</secondary_id>
    <secondary_id>MK-8628-001</secondary_id>
    <nct_id>NCT01713582</nct_id>
    <nct_alias>NCT02542358</nct_alias>
  </id_info>
  <brief_title>A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/ Birabresib (MK-8628) in Hematologic Malignancies (MK-8628-001)</brief_title>
  <official_title>A Phase I, Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/MK-8628 in Haematological Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oncoethix GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oncoethix GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study was to determine the recommended dose (RD) of birabresib&#xD;
      (MK-8628) /OTX015 for further phase II studies, in participants with acute leukemia (AL)&#xD;
      including acute myeloid leukemia (AML; de novo and secondary to a myelodysplastic syndrome)&#xD;
      and acute lymphoblastic leukemia (ALL) or other hematologic malignancies (OHM) including&#xD;
      diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM). The first phase of the study&#xD;
      will be a dose escalation phase to determine the Phase II RD using dose-limiting toxicities&#xD;
      (DLTs). Once the RD is determined, participants will be enrolled in an expansion phase at the&#xD;
      RD to determine preliminary efficacy in AL and OHM cohorts. Participants received therapy in&#xD;
      21-day cycles until disease progression, intolerable toxicity, or treatment interruption for&#xD;
      &gt;2 weeks due to toxicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2012</start_date>
  <completion_date type="Actual">January 20, 2017</completion_date>
  <primary_completion_date type="Actual">January 20, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>Cycle 1 (Up to 21 days)</time_frame>
    <description>A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting &gt;7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced at Least One Adverse Event (AE)</measure>
    <time_frame>Up to 40 days after last dose of study therapy (Up to 28 months)</time_frame>
    <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Study Therapy Due to AEs</measure>
    <time_frame>From time of first dose of study therapy until the end of treatment (up to 26 months)</time_frame>
    <description>All participants who discontinued study therapy due to an AE at any time during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)</measure>
    <time_frame>From time of first dose of study therapy until the end of treatment (up to 26 months)</time_frame>
    <description>Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of MK-8628/OTX015</measure>
    <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
    <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24 hours (h) + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Cmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Concentration (Tmax) of MK-8628/OTX015</measure>
    <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
    <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Tmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Half-Life (t1/2) of MK-8628/OTX015</measure>
    <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
    <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for t1/2 were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration Time Curve of MK-8628/OTX015 From Time 0 to Infinity (AUC 0-inf)</measure>
    <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
    <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for AUC 0-first were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Body Clearance (CL/F) of MK-8628/OTX015</measure>
    <time_frame>cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
    <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for CL/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution at Steady State (Vz/F) of MK-8628/OTX015</measure>
    <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
    <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Vz/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
  </secondary_outcome>
  <number_of_arms>21</number_of_arms>
  <enrollment type="Actual">141</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Diffuse Large B-cell Lymphoma</condition>
  <condition>Acute Lymphoblastic Leukemia</condition>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>AL 10 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 10 mg birabresib/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 20 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 40 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 20 mg BID 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 20 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 80 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 40 mg BID 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 40 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 120 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 120 mg QD 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AL 160 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 160 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AML de novo 80 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AML/MDS 80 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 10 mg QD 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 10 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 20 mg QD 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 40 mg QD 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 80 mg QD 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 40 mg BID 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 40 mg birabresib/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 120 mg QD 21-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 120 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 120 mg QD 5-7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM 120 mg QD 7-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OHM/DLBCL 80 mg QD 14-21</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OTX015/Birabresib</intervention_name>
    <description>OTX015/Birabresib 10 mg, 20 mg, or 40 mg capsules administered orally</description>
    <arm_group_label>AL 10 mg QD 14-21</arm_group_label>
    <arm_group_label>AL 120 mg QD 14-21</arm_group_label>
    <arm_group_label>AL 120 mg QD 21-21</arm_group_label>
    <arm_group_label>AL 160 mg QD 14-21</arm_group_label>
    <arm_group_label>AL 20 mg BID 21-21</arm_group_label>
    <arm_group_label>AL 20 mg QD 14-21</arm_group_label>
    <arm_group_label>AL 40 mg BID 14-21</arm_group_label>
    <arm_group_label>AL 40 mg QD 14-21</arm_group_label>
    <arm_group_label>AL 80 mg QD 14-21</arm_group_label>
    <arm_group_label>AML de novo 80 mg QD 14-21</arm_group_label>
    <arm_group_label>AML/MDS 80 mg QD 14-21</arm_group_label>
    <arm_group_label>OHM 10 mg QD 21-21</arm_group_label>
    <arm_group_label>OHM 120 mg QD 14-21</arm_group_label>
    <arm_group_label>OHM 120 mg QD 21-21</arm_group_label>
    <arm_group_label>OHM 120 mg QD 5-7</arm_group_label>
    <arm_group_label>OHM 120 mg QD 7-21</arm_group_label>
    <arm_group_label>OHM 20 mg QD 21-21</arm_group_label>
    <arm_group_label>OHM 40 mg BID 21-21</arm_group_label>
    <arm_group_label>OHM 40 mg QD 21-21</arm_group_label>
    <arm_group_label>OHM 80 mg QD 21-21</arm_group_label>
    <arm_group_label>OHM/DLBCL 80 mg QD 14-21</arm_group_label>
    <other_name>MK-8628</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically proven acute leukemias (AML or ALL) or hematologic&#xD;
             malignancies (DLBCL or MM) using standard diagnosis criteria. Acute leukemia includes&#xD;
             de novo and secondary to a pre-existing myelodysplastic syndrome, according to the&#xD;
             World Health Organization 2008 classification. For DLBCL, an archived&#xD;
             formaldehyde-fixed paraffin-embedded block must be available.&#xD;
&#xD;
          -  Has failed all standard therapies or for whom standard treatments are&#xD;
             contra-indicated:&#xD;
&#xD;
               -  Acute leukemia participants: &lt;60 years old in second relapse or relapsing after&#xD;
                  allogeneic stem cell transplantation (aSCT) regardless of number of relapses; &gt;60&#xD;
                  years old in first relapse with a disease-free interval (DFI) &lt;12 months or&#xD;
                  further relapse; irrespective of age, in participants relapsing after aSCT, the&#xD;
                  time elapsed since aSCT should be &gt;90 days; participants with B-cell ALL:&#xD;
                  Philadelphia chromosome positive (Ph+) must have received ≥2 lines of therapy,&#xD;
                  including 2 bcr-abl tyrosine-kinase (TK) inhibitors (among imatinib, nilotinib&#xD;
                  and dasatinib), or only 1 line including 1 TK inhibitor, if the&#xD;
                  relapse/refractoriness is associated with the detection of a resistance mutation&#xD;
                  to these inhibitors&#xD;
&#xD;
               -  DLBCL participants: Failed 2 standard lines of therapy (≥1 containing an&#xD;
                  anti-CD20 monoclonal antibody), or for whom such treatment is contra-indicated&#xD;
&#xD;
               -  MM participants: Adequately exposed to at least one alkylating agent, one&#xD;
                  corticosteroid, one immunomodulatory drug (IMiD) and bortezomib, or for whom such&#xD;
                  treatments are contra-indicated.&#xD;
&#xD;
          -  For participants with evaluable disease:&#xD;
&#xD;
               -  Advanced leukemia participants must have &gt;5% bone marrow blasts at study entry,&#xD;
                  without alternative causality (e.g. bone marrow regeneration)&#xD;
&#xD;
               -  DLBCL participants must have ≥1 non-irradiated tumor mass ≥15 mm (long axis of&#xD;
                  lymph node) or ≥10 mm (short axis of lymph node or extranodal lesions) on spiral&#xD;
                  computed tomography (CT)-scan.&#xD;
&#xD;
               -  MM participants must have ≥1 of the following: serum monoclonal component &gt;1 g/dL&#xD;
                  (IgG), or &gt;0.5 g/dL (IgA), or Bence-Jones (BJ) proteinuria &gt;200 mg/24h, or&#xD;
                  measurable plasmacytoma (not previously irradiated).&#xD;
&#xD;
          -  Life expectancy ≥3 months.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.&#xD;
&#xD;
          -  Off previous therapy ≥3 weeks prior to first study drug administration with full&#xD;
             recovery from any previous toxicities, except 1) hydroxyurea single agent of in&#xD;
             combination (e.g. + 6-Mercaptopurine [6MP]) to control hyperleukocytosis, which should&#xD;
             be stopped for ≥48 hours, and 2) rituximab, which should be stopped for ≥3 weeks.&#xD;
&#xD;
          -  Recovery from the non-hematologic toxic effects of prior treatment to grade ≤1,&#xD;
             according to National Cancer Institute Common Toxicity Criteria (NCI-CTC)&#xD;
             classification, except alopecia.&#xD;
&#xD;
          -  Adequate bone marrow function.&#xD;
&#xD;
          -  Adequate calculated creatinine clearance.&#xD;
&#xD;
          -  Adequate liver function tests.&#xD;
&#xD;
          -  Complete baseline disease assessment workup prior to first study drug administration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior malignancy other than those previously treated with a curative intent&#xD;
             &gt;3 years ago and without relapse (any tumor) or basal cell skin cancer, in situ&#xD;
             cervical cancer, superficial bladder cancer, or high grade intestinal polyps treated&#xD;
             adequately, regardless of the DFI.&#xD;
&#xD;
          -  Pregnant or lactating women or women of childbearing potential not using adequate&#xD;
             contraception. Male participants not using adequate contraception.&#xD;
&#xD;
          -  Peripheral cytopenias (i.e. auto-immune hemolytic anemia or thrombocytopenia).&#xD;
&#xD;
          -  Acute promyelocytic leukemia or with clinically uncontrolled (i.e. with bleeding)&#xD;
             disseminated intravascular coagulation (DIC).&#xD;
&#xD;
          -  Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the&#xD;
             control of GVHD.&#xD;
&#xD;
          -  Uncontrolled leptomeningeal disease.&#xD;
&#xD;
          -  Other tumor location necessitating an urgent therapeutic intervention (palliative&#xD;
             care, surgery or radiation therapy), such as spinal cord compression, other&#xD;
             compressive mass, uncontrolled painful lesion, bone fracture, etc.&#xD;
&#xD;
          -  Unable to swallow oral medications, or has gastrointestinal condition (e.g.&#xD;
             malabsorption, resection) deemed to jeopardize intestinal absorption.&#xD;
&#xD;
          -  Other serious illness or medical conditions, which, in the investigator's opinion&#xD;
             could hamper understanding of the study by the participants, participant's compliance&#xD;
             to study treatment, participant's safety or interpretation of study results. These&#xD;
             conditions include (but are not restricted to):&#xD;
&#xD;
               1. Congestive heart failure or angina pectoris except if medically controlled.&#xD;
                  Previous history of myocardial infarction within 1 year of study entry,&#xD;
                  uncontrolled hypertension or arrhythmias.&#xD;
&#xD;
               2. Existence of significant neurologic or psychiatric disorders impairing the&#xD;
                  ability to obtain consent.&#xD;
&#xD;
               3. Uncontrolled infection.&#xD;
&#xD;
               4. Known human immunodeficiency virus (HIV) positivity&#xD;
&#xD;
          -  Concurrent treatment with other experimental therapies or participation in another&#xD;
             clinical trial within 30 days prior to first study drug administration.&#xD;
&#xD;
          -  Concurrent treatment or treatment within 30 days prior to first study drug&#xD;
             administration with any other anticancer therapy, except hydroxyurea (+/- 6MP) to&#xD;
             control hyperleukocytosis.&#xD;
&#xD;
          -  Concomitant treatment with corticosteroids except if chronic treatment with ≤30 mg of&#xD;
             methylprednisolone daily or equivalent dose of other corticosteroids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <removed_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </removed_countries>
  <results_reference>
    <citation>Odore E, Lokiec F, Cvitkovic E, Bekradda M, Herait P, Bourdel F, Kahatt C, Raffoux E, Stathis A, Thieblemont C, Quesnel B, Cunningham D, Riveiro ME, Rezai K. Phase I Population Pharmacokinetic Assessment of the Oral Bromodomain Inhibitor OTX015 in Patients with Haematologic Malignancies. Clin Pharmacokinet. 2016 Mar;55(3):397-405. doi: 10.1007/s40262-015-0327-6.</citation>
    <PMID>26341814</PMID>
  </results_reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <results_first_submitted>January 11, 2018</results_first_submitted>
  <results_first_submitted_qc>February 7, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 1, 2018</results_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT01713582/SAP_000.pdf</document_url>
    </provided_document>
    <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>December 18, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT01713582/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>80 participants were enrolled in the acute leukemia (AL) cohort and 78 were treated. 61 participants were enrolled in the other hematological malignancies (OHM) cohort and 60 were treated.</recruitment_details>
      <pre_assignment_details>The study consisted of a dose escalation phase in participants with AL and OHM followed by and expansion phase in 3 cohorts: de novo acute myelocytic leukemia (AML), myelodysplastic syndrome (MDS) AML, and diffuse large B-cell lymphoma (DLBCL).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AL 10 mg QD 14-21</title>
          <description>Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P2">
          <title>AL 20 mg QD 14-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P3">
          <title>AL 40 mg QD 14-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P4">
          <title>AL 20 mg BID 21-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P5">
          <title>AL 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P6">
          <title>AL 40 mg BID 14-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P7">
          <title>AL 120 mg QD 14-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P8">
          <title>AL 120 mg QD 21-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P9">
          <title>AL 160 mg QD 14-21</title>
          <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P10">
          <title>AML de Novo 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P11">
          <title>AML/MDS 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P12">
          <title>OHM 10 mg QD 21-21</title>
          <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P13">
          <title>OHM 20 mg QD 21-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P14">
          <title>OHM 40 mg QD 21-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P15">
          <title>OHM 80 mg QD 21-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P16">
          <title>OHM 40 mg BID 21-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P17">
          <title>OHM 120 mg QD 21-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="P18">
          <title>OHM 120 mg QD 14-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="P19">
          <title>OHM 120 mg QD 5-7</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
        </group>
        <group group_id="P20">
          <title>OHM 120 mg QD 7-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.</description>
        </group>
        <group group_id="P21">
          <title>OHM/DLBCL 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3">Number treated</participants>
                <participants group_id="P2" count="3">Number treated</participants>
                <participants group_id="P3" count="4">Number treated</participants>
                <participants group_id="P4" count="3">Number treated</participants>
                <participants group_id="P5" count="4">Number treated</participants>
                <participants group_id="P6" count="8">Number treated</participants>
                <participants group_id="P7" count="7">Number treated</participants>
                <participants group_id="P8" count="6">Number treated</participants>
                <participants group_id="P9" count="6">Number treated</participants>
                <participants group_id="P10" count="18">Number treated</participants>
                <participants group_id="P11" count="16">Number treated</participants>
                <participants group_id="P12" count="5">Number treated</participants>
                <participants group_id="P13" count="3">Number treated</participants>
                <participants group_id="P14" count="4">Number treated</participants>
                <participants group_id="P15" count="7">Number treated</participants>
                <participants group_id="P16" count="6">Number treated</participants>
                <participants group_id="P17" count="7">Number treated</participants>
                <participants group_id="P18" count="3">Number treated</participants>
                <participants group_id="P19" count="5">Number treated</participants>
                <participants group_id="P20" count="5">Number treated</participants>
                <participants group_id="P21" count="15">Number treated</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="18"/>
                <participants group_id="P11" count="16"/>
                <participants group_id="P12" count="5"/>
                <participants group_id="P13" count="3"/>
                <participants group_id="P14" count="4"/>
                <participants group_id="P15" count="7"/>
                <participants group_id="P16" count="6"/>
                <participants group_id="P17" count="7"/>
                <participants group_id="P18" count="3"/>
                <participants group_id="P19" count="5"/>
                <participants group_id="P20" count="5"/>
                <participants group_id="P21" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="11"/>
                <participants group_id="P11" count="10"/>
                <participants group_id="P12" count="5"/>
                <participants group_id="P13" count="3"/>
                <participants group_id="P14" count="3"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="6"/>
                <participants group_id="P17" count="5"/>
                <participants group_id="P18" count="2"/>
                <participants group_id="P19" count="3"/>
                <participants group_id="P20" count="5"/>
                <participants group_id="P21" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="4"/>
                <participants group_id="P11" count="3"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event-related</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="1"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event-unrelated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="1"/>
                <participants group_id="P15" count="1"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal of consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="1"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="2"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="1"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Stopped to receive bone marrow graft</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="1"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression and adverse event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="1"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>AL 10 mg QD 14-21</title>
          <description>Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B2">
          <title>AL 20 mg QD 14-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B3">
          <title>AL 40 mg QD 14-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B4">
          <title>AL 20 mg BID 21-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B5">
          <title>AL 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B6">
          <title>AL 40 mg BID 14-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B7">
          <title>AL 120 mg QD 14-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B8">
          <title>AL 120 mg QD 21-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B9">
          <title>AL 160 mg QD 14-21</title>
          <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B10">
          <title>AML de Novo 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B11">
          <title>AML/MDS 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B12">
          <title>OHM 10 mg QD 21-21</title>
          <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B13">
          <title>OHM 20 mg QD 21-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B14">
          <title>OHM 40 mg QD 21-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B15">
          <title>OHM 80 mg QD 21-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B16">
          <title>OHM 40 mg BID 21-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B17">
          <title>OHM 120 mg QD 21-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="B18">
          <title>OHM 120 mg QD 14-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B19">
          <title>OHM 120 mg QD 5-7</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
        </group>
        <group group_id="B20">
          <title>OHM 120 mg QD 7-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.</description>
        </group>
        <group group_id="B21">
          <title>OHM/DLBCL 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="B22">
          <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="3"/>
            <count group_id="B2" value="3"/>
            <count group_id="B3" value="4"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="4"/>
            <count group_id="B6" value="8"/>
            <count group_id="B7" value="7"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="18"/>
            <count group_id="B11" value="16"/>
            <count group_id="B12" value="5"/>
            <count group_id="B13" value="3"/>
            <count group_id="B14" value="4"/>
            <count group_id="B15" value="7"/>
            <count group_id="B16" value="6"/>
            <count group_id="B17" value="7"/>
            <count group_id="B18" value="3"/>
            <count group_id="B19" value="5"/>
            <count group_id="B20" value="5"/>
            <count group_id="B21" value="15"/>
            <count group_id="B22" value="138"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="4"/>
                    <count group_id="B4" value="3"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="8"/>
                    <count group_id="B7" value="7"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="6"/>
                    <count group_id="B10" value="18"/>
                    <count group_id="B11" value="16"/>
                    <count group_id="B12" value="5"/>
                    <count group_id="B13" value="3"/>
                    <count group_id="B14" value="4"/>
                    <count group_id="B15" value="7"/>
                    <count group_id="B16" value="6"/>
                    <count group_id="B17" value="7"/>
                    <count group_id="B18" value="3"/>
                    <count group_id="B19" value="5"/>
                    <count group_id="B20" value="5"/>
                    <count group_id="B21" value="15"/>
                    <count group_id="B22" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.0" spread="3.5" lower_limit="65.0" upper_limit="71.0"/>
                    <measurement group_id="B2" value="54.7" spread="19.6" lower_limit="32.0" upper_limit="66.0"/>
                    <measurement group_id="B3" value="73.8" spread="2.1" lower_limit="71.0" upper_limit="76.0"/>
                    <measurement group_id="B4" value="77.7" spread="2.3" lower_limit="75.0" upper_limit="79.0"/>
                    <measurement group_id="B5" value="70.0" spread="10.6" lower_limit="55.0" upper_limit="80.0"/>
                    <measurement group_id="B6" value="65.8" spread="16.3" lower_limit="33.0" upper_limit="85.0"/>
                    <measurement group_id="B7" value="65.3" spread="13.9" lower_limit="42.0" upper_limit="79.0"/>
                    <measurement group_id="B8" value="58.5" spread="24.1" lower_limit="19.0" upper_limit="80.0"/>
                    <measurement group_id="B9" value="57.8" spread="16.6" lower_limit="26.0" upper_limit="75.0"/>
                    <measurement group_id="B10" value="65.6" spread="10.0" lower_limit="45.0" upper_limit="79.0"/>
                    <measurement group_id="B11" value="67.2" spread="8.2" lower_limit="48.0" upper_limit="81.0"/>
                    <measurement group_id="B12" value="65.2" spread="15.5"/>
                    <measurement group_id="B13" value="74.7" spread="7.4"/>
                    <measurement group_id="B14" value="69.0" spread="8.4"/>
                    <measurement group_id="B15" value="59.4" spread="18.5"/>
                    <measurement group_id="B16" value="54.7" spread="13.0"/>
                    <measurement group_id="B17" value="55.6" spread="19.3"/>
                    <measurement group_id="B18" value="66.0" spread="13.2"/>
                    <measurement group_id="B19" value="62.4" spread="8.4"/>
                    <measurement group_id="B20" value="66.8" spread="8.3"/>
                    <measurement group_id="B21" value="58.5" spread="14.1"/>
                    <measurement group_id="B22" value="63.7" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="3"/>
                    <count group_id="B2" value="3"/>
                    <count group_id="B3" value="4"/>
                    <count group_id="B4" value="3"/>
                    <count group_id="B5" value="4"/>
                    <count group_id="B6" value="8"/>
                    <count group_id="B7" value="7"/>
                    <count group_id="B8" value="6"/>
                    <count group_id="B9" value="6"/>
                    <count group_id="B10" value="18"/>
                    <count group_id="B11" value="16"/>
                    <count group_id="B12" value="5"/>
                    <count group_id="B13" value="3"/>
                    <count group_id="B14" value="4"/>
                    <count group_id="B15" value="7"/>
                    <count group_id="B16" value="6"/>
                    <count group_id="B17" value="7"/>
                    <count group_id="B18" value="3"/>
                    <count group_id="B19" value="5"/>
                    <count group_id="B20" value="5"/>
                    <count group_id="B21" value="15"/>
                    <count group_id="B22" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="8"/>
                    <measurement group_id="B11" value="3"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="1"/>
                    <measurement group_id="B14" value="2"/>
                    <measurement group_id="B15" value="3"/>
                    <measurement group_id="B16" value="3"/>
                    <measurement group_id="B17" value="2"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="5"/>
                    <measurement group_id="B21" value="4"/>
                    <measurement group_id="B22" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="10"/>
                    <measurement group_id="B11" value="13"/>
                    <measurement group_id="B12" value="5"/>
                    <measurement group_id="B13" value="2"/>
                    <measurement group_id="B14" value="2"/>
                    <measurement group_id="B15" value="4"/>
                    <measurement group_id="B16" value="3"/>
                    <measurement group_id="B17" value="5"/>
                    <measurement group_id="B18" value="3"/>
                    <measurement group_id="B19" value="5"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="11"/>
                    <measurement group_id="B22" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                    <count group_id="B5" value="0"/>
                    <count group_id="B6" value="0"/>
                    <count group_id="B7" value="0"/>
                    <count group_id="B8" value="0"/>
                    <count group_id="B9" value="0"/>
                    <count group_id="B10" value="0"/>
                    <count group_id="B11" value="0"/>
                    <count group_id="B12" value="0"/>
                    <count group_id="B13" value="0"/>
                    <count group_id="B14" value="0"/>
                    <count group_id="B15" value="0"/>
                    <count group_id="B16" value="0"/>
                    <count group_id="B17" value="0"/>
                    <count group_id="B18" value="0"/>
                    <count group_id="B19" value="0"/>
                    <count group_id="B20" value="0"/>
                    <count group_id="B21" value="0"/>
                    <count group_id="B22" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B22" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Dose Limiting Toxicities (DLTs)</title>
        <description>A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting &gt;7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).</description>
        <time_frame>Cycle 1 (Up to 21 days)</time_frame>
        <population>All participants who received at least 85% of the intended dose of study therapy during the first cycle (i.e. &gt;12 days at full dose for AL and &gt;18 days at full dose for other hematological malignancies) or discontinued from the study due to a DLT attributable to study therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>AL 10 mg QD 14-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>AL 20 mg QD 14-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>AL 40 mg QD 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>AL 20 mg BID 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>AL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>AL 40 mg BID 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O7">
            <title>AL 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O8">
            <title>AL 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O9">
            <title>AL 160 mg QD 14-21</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O10">
            <title>AML de Novo 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O11">
            <title>AML/MDS 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O12">
            <title>OHM 10 mg QD 21-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O13">
            <title>OHM 20 mg QD 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O14">
            <title>OHM 40 mg QD 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O15">
            <title>OHM 80 mg QD 21-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O16">
            <title>OHM 40 mg BID 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O17">
            <title>OHM 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O18">
            <title>OHM 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O19">
            <title>OHM 120 mg QD 5-7</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
          </group>
          <group group_id="O20">
            <title>OHM 120 mg QD 7-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.</description>
          </group>
          <group group_id="O21">
            <title>OHM/DLBCL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dose Limiting Toxicities (DLTs)</title>
          <description>A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting &gt;7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).</description>
          <population>All participants who received at least 85% of the intended dose of study therapy during the first cycle (i.e. &gt;12 days at full dose for AL and &gt;18 days at full dose for other hematological malignancies) or discontinued from the study due to a DLT attributable to study therapy.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="17"/>
                <count group_id="O11" value="14"/>
                <count group_id="O12" value="3"/>
                <count group_id="O13" value="3"/>
                <count group_id="O14" value="3"/>
                <count group_id="O15" value="7"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="6"/>
                <count group_id="O18" value="3"/>
                <count group_id="O19" value="4"/>
                <count group_id="O20" value="5"/>
                <count group_id="O21" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="2"/>
                    <measurement group_id="O16" value="5"/>
                    <measurement group_id="O17" value="4"/>
                    <measurement group_id="O18" value="2"/>
                    <measurement group_id="O19" value="3"/>
                    <measurement group_id="O20" value="2"/>
                    <measurement group_id="O21" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced at Least One Adverse Event (AE)</title>
        <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.</description>
        <time_frame>Up to 40 days after last dose of study therapy (Up to 28 months)</time_frame>
        <population>All participants who received at least one dose of study therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>AL 10 mg QD 14-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>AL 20 mg QD 14-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>AL 40 mg QD 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>AL 20 mg BID 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>AL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>AL 40 mg BID 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O7">
            <title>AL 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O8">
            <title>AL 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O9">
            <title>AL 160 mg QD 14-21</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O10">
            <title>AML de Novo 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O11">
            <title>AML/MDS 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O12">
            <title>OHM 10 mg QD 21-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O13">
            <title>OHM 20 mg QD 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O14">
            <title>OHM 40 mg QD 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O15">
            <title>OHM 80 mg QD 21-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O16">
            <title>OHM 40 mg BID 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O17">
            <title>OHM 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O18">
            <title>OHM 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O19">
            <title>OHM 120 mg QD 5-7</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
          </group>
          <group group_id="O20">
            <title>OHM 120 mg QD 7-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.</description>
          </group>
          <group group_id="O21">
            <title>OHM/DLBCL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced at Least One Adverse Event (AE)</title>
          <description>AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.</description>
          <population>All participants who received at least one dose of study therapy.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="18"/>
                <count group_id="O11" value="16"/>
                <count group_id="O12" value="5"/>
                <count group_id="O13" value="3"/>
                <count group_id="O14" value="4"/>
                <count group_id="O15" value="7"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="7"/>
                <count group_id="O18" value="3"/>
                <count group_id="O19" value="5"/>
                <count group_id="O20" value="5"/>
                <count group_id="O21" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="6"/>
                    <measurement group_id="O10" value="18"/>
                    <measurement group_id="O11" value="16"/>
                    <measurement group_id="O12" value="5"/>
                    <measurement group_id="O13" value="3"/>
                    <measurement group_id="O14" value="4"/>
                    <measurement group_id="O15" value="7"/>
                    <measurement group_id="O16" value="6"/>
                    <measurement group_id="O17" value="7"/>
                    <measurement group_id="O18" value="3"/>
                    <measurement group_id="O19" value="5"/>
                    <measurement group_id="O20" value="5"/>
                    <measurement group_id="O21" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Study Therapy Due to AEs</title>
        <description>All participants who discontinued study therapy due to an AE at any time during treatment.</description>
        <time_frame>From time of first dose of study therapy until the end of treatment (up to 26 months)</time_frame>
        <population>All participants who received at least one dose of study therapy.</population>
        <group_list>
          <group group_id="O1">
            <title>AL 10 mg QD 14-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>AL 20 mg QD 14-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>AL 40 mg QD 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>AL 20 mg BID 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>AL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>AL 40 mg BID 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O7">
            <title>AL 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O8">
            <title>AL 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O9">
            <title>AL 160 mg QD 14-21</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O10">
            <title>AML de Novo 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O11">
            <title>AML/MDS 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O12">
            <title>OHM 10 mg QD 21-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O13">
            <title>OHM 20 mg QD 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O14">
            <title>OHM 40 mg QD 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O15">
            <title>OHM 80 mg QD 21-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O16">
            <title>OHM 40 mg BID 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O17">
            <title>OHM 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O18">
            <title>OHM 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O19">
            <title>OHM 120 mg QD 5-7</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
          </group>
          <group group_id="O20">
            <title>OHM 120 mg QD 7-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.</description>
          </group>
          <group group_id="O21">
            <title>OHM/DLBCL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Study Therapy Due to AEs</title>
          <description>All participants who discontinued study therapy due to an AE at any time during treatment.</description>
          <population>All participants who received at least one dose of study therapy.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="18"/>
                <count group_id="O11" value="16"/>
                <count group_id="O12" value="5"/>
                <count group_id="O13" value="3"/>
                <count group_id="O14" value="4"/>
                <count group_id="O15" value="7"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="7"/>
                <count group_id="O18" value="3"/>
                <count group_id="O19" value="5"/>
                <count group_id="O20" value="5"/>
                <count group_id="O21" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="4"/>
                    <measurement group_id="O10" value="7"/>
                    <measurement group_id="O11" value="4"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="1"/>
                    <measurement group_id="O15" value="1"/>
                    <measurement group_id="O16" value="1"/>
                    <measurement group_id="O17" value="2"/>
                    <measurement group_id="O18" value="1"/>
                    <measurement group_id="O19" value="2"/>
                    <measurement group_id="O20" value="0"/>
                    <measurement group_id="O21" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)</title>
        <description>Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.</description>
        <time_frame>From time of first dose of study therapy until the end of treatment (up to 26 months)</time_frame>
        <population>All participants who received one dose of study therapy and had at least one available tumor assessment by the end of Cycle 2 or later or with earlier evidence of response or progression.</population>
        <group_list>
          <group group_id="O1">
            <title>AL 10 mg QD 14-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>AL 20 mg QD 14-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O3">
            <title>AL 40 mg QD 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O4">
            <title>AL 20 mg BID 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O5">
            <title>AL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O6">
            <title>AL 40 mg BID 14-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O7">
            <title>AL 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O8">
            <title>AL 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O9">
            <title>AL 160 mg QD 14-21</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O10">
            <title>AML de Novo 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O11">
            <title>AML/MDS 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O12">
            <title>OHM 10 mg QD 21-21</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O13">
            <title>OHM 20 mg QD 21-21</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O14">
            <title>OHM 40 mg QD 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O15">
            <title>OHM 80 mg QD 21-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O16">
            <title>OHM 40 mg BID 21-21</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O17">
            <title>OHM 120 mg QD 21-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
          </group>
          <group group_id="O18">
            <title>OHM 120 mg QD 14-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
          <group group_id="O19">
            <title>OHM 120 mg QD 5-7</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
          </group>
          <group group_id="O20">
            <title>OHM 120 mg QD 7-21</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.</description>
          </group>
          <group group_id="O21">
            <title>OHM/DLBCL 80 mg QD 14-21</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)</title>
          <description>Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.</description>
          <population>All participants who received one dose of study therapy and had at least one available tumor assessment by the end of Cycle 2 or later or with earlier evidence of response or progression.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="7"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="18"/>
                <count group_id="O11" value="16"/>
                <count group_id="O12" value="5"/>
                <count group_id="O13" value="3"/>
                <count group_id="O14" value="4"/>
                <count group_id="O15" value="7"/>
                <count group_id="O16" value="6"/>
                <count group_id="O17" value="7"/>
                <count group_id="O18" value="3"/>
                <count group_id="O19" value="5"/>
                <count group_id="O20" value="5"/>
                <count group_id="O21" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="0"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="1"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="1"/>
                    <measurement group_id="O18" value="1"/>
                    <measurement group_id="O19" value="0"/>
                    <measurement group_id="O20" value="0"/>
                    <measurement group_id="O21" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Concentration (Cmax) of MK-8628/OTX015</title>
        <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24 hours (h) + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Cmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
        <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
        <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>10 mg QD Dose Escalation Cohort</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O2">
            <title>20 mg QD Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O3">
            <title>40 mg QD Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>20 mg BID Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>80 mg QD Dose Escalation Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O6">
            <title>40 mg BID Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O7">
            <title>120 mg QD Dose Escalation Cohort</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O8">
            <title>160 mg QD Dose Escalation Cohort</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O9">
            <title>80 mg QD Expansion Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) of MK-8628/OTX015</title>
          <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24 hours (h) + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Cmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
          <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
          <units>ug/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131" spread="56.5"/>
                    <measurement group_id="O2" value="275" spread="104"/>
                    <measurement group_id="O3" value="627" spread="328"/>
                    <measurement group_id="O4" value="453" spread="185"/>
                    <measurement group_id="O5" value="1131" spread="650"/>
                    <measurement group_id="O6" value="556" spread="194"/>
                    <measurement group_id="O7" value="1425" spread="555"/>
                    <measurement group_id="O8" value="1292" spread="572"/>
                    <measurement group_id="O9" value="982" spread="316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Concentration (Tmax) of MK-8628/OTX015</title>
        <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Tmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
        <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
        <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>10 mg QD Dose Escalation Cohort</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O2">
            <title>20 mg QD Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O3">
            <title>40 mg QD Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>20 mg BID Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>80 mg QD Dose Escalation Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O6">
            <title>40 mg BID Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O7">
            <title>120 mg QD Dose Escalation Cohort</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O8">
            <title>160 mg QD Dose Escalation Cohort</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O9">
            <title>80 mg QD Expansion Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Concentration (Tmax) of MK-8628/OTX015</title>
          <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Tmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
          <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78" spread="1.37"/>
                    <measurement group_id="O2" value="3.03" spread="1.54"/>
                    <measurement group_id="O3" value="1.75" spread="1.04"/>
                    <measurement group_id="O4" value="1.92" spread="0.795"/>
                    <measurement group_id="O5" value="3.44" spread="1.21"/>
                    <measurement group_id="O6" value="2.73" spread="2.08"/>
                    <measurement group_id="O7" value="3.48" spread="1.35"/>
                    <measurement group_id="O8" value="4.22" spread="2.46"/>
                    <measurement group_id="O9" value="3.07" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Half-Life (t1/2) of MK-8628/OTX015</title>
        <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for t1/2 were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
        <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
        <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>10 mg QD Dose Escalation Cohort</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD in a fasted state.</description>
          </group>
          <group group_id="O2">
            <title>20 mg QD Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O3">
            <title>40 mg QD Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>20 mg BID Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>80 mg QD Dose Escalation Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O6">
            <title>40 mg BID Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O7">
            <title>120 mg QD Dose Escalation Cohort</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O8">
            <title>160 mg QD Dose Escalation Cohort</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O9">
            <title>80 mg QD Expansion Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state..</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-Life (t1/2) of MK-8628/OTX015</title>
          <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for t1/2 were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
          <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.65" spread="0.695"/>
                    <measurement group_id="O2" value="4.78" spread="1.53"/>
                    <measurement group_id="O3" value="4.55" spread="0.533"/>
                    <measurement group_id="O4" value="4.71" spread="1.1"/>
                    <measurement group_id="O5" value="4.62" spread="0.673"/>
                    <measurement group_id="O6" value="4.70" spread="1.19"/>
                    <measurement group_id="O7" value="4.49" spread="1.01"/>
                    <measurement group_id="O8" value="3.87" spread="0.712"/>
                    <measurement group_id="O9" value="4.27" spread="0.940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration Time Curve of MK-8628/OTX015 From Time 0 to Infinity (AUC 0-inf)</title>
        <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for AUC 0-first were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
        <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
        <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>10 mg QD Dose Escalation Cohort</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O2">
            <title>20 mg QD Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O3">
            <title>40 mg QD Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>20 mg BID Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>80 mg QD Dose Escalation Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O6">
            <title>40 mg BID Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O7">
            <title>120 mg QD Dose Escalation Cohort</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O8">
            <title>160 mg QD Dose Escalation Cohort</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O9">
            <title>80 mg QD Expansion Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time Curve of MK-8628/OTX015 From Time 0 to Infinity (AUC 0-inf)</title>
          <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for AUC 0-first were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
          <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
          <units>hr*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1060" spread="191"/>
                    <measurement group_id="O2" value="2828" spread="983"/>
                    <measurement group_id="O3" value="5301" spread="924"/>
                    <measurement group_id="O4" value="3947" spread="1184"/>
                    <measurement group_id="O5" value="11910" spread="6987"/>
                    <measurement group_id="O6" value="5619" spread="1895"/>
                    <measurement group_id="O7" value="15240" spread="6021"/>
                    <measurement group_id="O8" value="13190" spread="3183"/>
                    <measurement group_id="O9" value="9833" spread="2968"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Total Body Clearance (CL/F) of MK-8628/OTX015</title>
        <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for CL/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
        <time_frame>cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
        <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>10 mg QD Dose Escalation Cohort</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O2">
            <title>20 mg QD Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O3">
            <title>40 mg QD Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state..</description>
          </group>
          <group group_id="O4">
            <title>20 mg BID Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>80 mg QD Dose Escalation Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O6">
            <title>40 mg BID Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O7">
            <title>120 mg QD Dose Escalation Cohort</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O8">
            <title>160 mg QD Dose Escalation Cohort</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O9">
            <title>80 mg QD Expansion Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Body Clearance (CL/F) of MK-8628/OTX015</title>
          <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for CL/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
          <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
          <units>L/hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.71" spread="1.73"/>
                    <measurement group_id="O2" value="7.67" spread="2.13"/>
                    <measurement group_id="O3" value="7.76" spread="1.38"/>
                    <measurement group_id="O4" value="6.53" spread="1.88"/>
                    <measurement group_id="O5" value="7.91" spread="3.04"/>
                    <measurement group_id="O6" value="7.49" spread="2.18"/>
                    <measurement group_id="O7" value="8.61" spread="2.22"/>
                    <measurement group_id="O8" value="12.7" spread="2.80"/>
                    <measurement group_id="O9" value="8.87" spread="2.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution at Steady State (Vz/F) of MK-8628/OTX015</title>
        <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Vz/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
        <time_frame>Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position</time_frame>
        <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
        <group_list>
          <group group_id="O1">
            <title>10 mg QD Dose Escalation Cohort</title>
            <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O2">
            <title>20 mg QD Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O3">
            <title>40 mg QD Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O4">
            <title>20 mg BID Dose Escalation Cohort</title>
            <description>Participants received 20 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O5">
            <title>80 mg QD Dose Escalation Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O6">
            <title>40 mg BID Dose Escalation Cohort</title>
            <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state.</description>
          </group>
          <group group_id="O7">
            <title>120 mg QD Dose Escalation Cohort</title>
            <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O8">
            <title>160 mg QD Dose Escalation Cohort</title>
            <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
          <group group_id="O9">
            <title>80 mg QD Expansion Cohort</title>
            <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution at Steady State (Vz/F) of MK-8628/OTX015</title>
          <description>Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.&#xD;
Blood samples for Vz/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.</description>
          <population>All participants that received at least 1 dose of study therapy and had evaluable data for endpoint. Results were pooled by dose taken and not by disease or regimen.</population>
          <units>Liters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="11"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="31"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.6" spread="1.0"/>
                    <measurement group_id="O2" value="49.1" spread="3.51"/>
                    <measurement group_id="O3" value="50.8" spread="10.0"/>
                    <measurement group_id="O4" value="42.4" spread="4.25"/>
                    <measurement group_id="O5" value="50.4" spread="17.5"/>
                    <measurement group_id="O6" value="48.2" spread="9.22"/>
                    <measurement group_id="O7" value="54.2" spread="14.4"/>
                    <measurement group_id="O8" value="69.3" spread="13.3"/>
                    <measurement group_id="O9" value="52.0" spread="9.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored up to 40 days after last dose of study therapy (Up to 28 months).</time_frame>
      <desc>The safety population consisted of all participants who received at least one dose of study therapy.</desc>
      <group_list>
        <group group_id="E1">
          <title>AL 10 mg QD 14-21</title>
          <description>Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E2">
          <title>AL 20 mg QD 14-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E3">
          <title>AL 40 mg QD 14-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E4">
          <title>AL 20 mg BID 21-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="E5">
          <title>AL 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E6">
          <title>AL 40 mg BID 14-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E7">
          <title>AL 120 mg QD 14-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E8">
          <title>AL 120 mg QD 21-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="E9">
          <title>AL 160 mg QD 14-21</title>
          <description>Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E10">
          <title>AML de Novo 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E11">
          <title>AML/MDS 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E12">
          <title>OHM 10 mg QD 21-21</title>
          <description>Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="E13">
          <title>OHM 20 mg QD 21-21</title>
          <description>Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="E14">
          <title>OHM 40 mg QD 21-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="E15">
          <title>OHM 40 mg BID 21-21</title>
          <description>Participants received 40 mg MK-8628/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="E16">
          <title>OHM 120 mg QD 21-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
        <group group_id="E17">
          <title>OHM 120 mg QD 14-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E18">
          <title>OHM 120 mg QD 5-7</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.</description>
        </group>
        <group group_id="E19">
          <title>OHM 120 mg QD 7-21</title>
          <description>Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle.</description>
        </group>
        <group group_id="E20">
          <title>OHM/DLBCL 80 mg QD 14-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.</description>
        </group>
        <group group_id="E21">
          <title>OHM 80 mg QD 21-21</title>
          <description>Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="15" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="9" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="4" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="14" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="14" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="4" subjects_at_risk="7"/>
              </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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Febrile bone marrow aplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemorrhagic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Anorectal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Faecal incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Puncture site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cerebral aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Enterobacter infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infectious peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lung infection pseudomonal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pseudomonas infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Viral skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Enterococcus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Factor VII deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </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="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Air embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</default_vocab>
        <default_assessment>Non-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="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="18" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="16" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="5" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="15" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="7" subjects_at_risk="7"/>
              </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="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="4" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemorrhagic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="3" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Conduction disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Factor V deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Exophthalmos</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eye disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Periorbital oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Ulcerative keratitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Breath odour</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="11" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="9" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="6" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Duodenogastric reflux</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Faecal incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gingival disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gingival hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="11" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="3" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tongue coated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="10" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="10" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="3" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Localised Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Puncture site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Puncture site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sense of oppression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cytolytic hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Clostridial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gingival infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Human herpesvirus 6 infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infection reactivation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Localized infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lyme disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lymphangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oral fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Periodontal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Prostate infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Prostatitis escherichia coli</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhinotracheitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tinea Cruris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Viral skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vulvitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </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="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Excoriation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eyelid injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Transfusion related complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Aspergillus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bilirubin conjugated increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Factor VII deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>International normalised ratio</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>International normalised ratio decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Prothrombin time shortened</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </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="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="9" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="3" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </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="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Back disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bone disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Leukoerythroblastosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Convulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Facial nerve disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Intracranial aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Viith nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hallucination, visual</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary hesitation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nipple disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Laryngeal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lung consolidation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eccymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Erythrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Scab</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor has the opportunity to review all proposed publications regarding this trial 60 days prior to submission for publication. In addition, if requested, the investigator will withhold publication an additional 90 days to allow for filing a patent application or taking such other measures to establish and preserve its proprietary rights. Publication of the results of the study shall be made only as part of a publication of the results obtained by all sites performing the protocol.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT01713582
org study id: 8628-001
secondary id: OTX015_104
secondary id: 2012-003380-22
secondary id: MK-8628-001
nct id: NCT01713582
nct alias: NCT02542358
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study was to determine the recommended dose (RD) of birabresib
      (MK-8628) /OTX015 for further phase II studies, in participants with acute leukemia (AL)
      including acute myeloid leukemia (AML; de novo and secondary to a myelodysplastic syndrome)
      and acute lymphoblastic leukemia (ALL) or other hematologic malignancies (OHM) including
      diffuse large B cell lymphoma (DLBCL) and multiple myeloma (MM). The first phase of the study
      will be a dose escalation phase to determine the Phase II RD using dose-limiting toxicities
      (DLTs). Once the RD is determined, participants will be enrolled in an expansion phase at the
      RD to determine preliminary efficacy in AL and OHM cohorts. Participants received therapy in
      21-day cycles until disease progression, intolerable toxicity, or treatment interruption for
      >2 weeks due to toxicity.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
time frame: Cycle 1 (Up to 21 days)
description: A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting >7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
measure: Number of Participants Who Experienced at Least One Adverse Event (AE)
time frame: Up to 40 days after last dose of study therapy (Up to 28 months)
description: AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. AEs were collected during the entire time frame of treatment plus up to 40 days of follow-up.
measure: Number of Participants Who Discontinued Study Therapy Due to AEs
time frame: From time of first dose of study therapy until the end of treatment (up to 26 months)
description: All participants who discontinued study therapy due to an AE at any time during treatment.
measure: Number of Participants Whose Best Response Was Partial Response (PR) or Complete Response (CR)
time frame: From time of first dose of study therapy until the end of treatment (up to 26 months)
description: Best response was determined from the start of treatment until disease progression, recurrence, or completion of 26 months of treatment. Partial and complete response was assessed by bone marrow aspiration (AL participants); or computed tomography scan, magnetic resonance imaging, positron emission tomography, or X-ray (OHM participants) using standard criteria. Acute leukemia participants were assessed based on the recommendations from the European LeukemiaNet Döhner 2010); lymphoma participants according to Cheson 2007; and MM participants according to Durie 2006.
measure: Maximum Concentration (Cmax) of MK-8628/OTX015
time frame: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position
description: Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24 hours (h) + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.
Blood samples for Cmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
measure: Time to Maximum Concentration (Tmax) of MK-8628/OTX015
time frame: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position
description: Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.
Blood samples for Tmax were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
measure: Apparent Terminal Half-Life (t1/2) of MK-8628/OTX015
time frame: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position
description: Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.
Blood samples for t1/2 were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
measure: Area Under the Concentration Time Curve of MK-8628/OTX015 From Time 0 to Infinity (AUC 0-inf)
time frame: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position
description: Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.
Blood samples for AUC 0-first were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
measure: Apparent Total Body Clearance (CL/F) of MK-8628/OTX015
time frame: cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position
description: Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.
Blood samples for CL/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
measure: Volume of Distribution at Steady State (Vz/F) of MK-8628/OTX015
time frame: Cycle 1: Pre-infusion and 20 minutes; 1, 2.25, 3.25, 4, 6, 8, 9, 12, and 24 hours plus one sampling at either 10 hour or 16 hour post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion dependent on dose regimen and enrollment position
description: Data were collected in Cycle 1 according to dosing regimen and enrollment position at the following sampling schedules: 1) Complete QD for the first 3 participants per dose level: Pre-infusion and 1, 4, 8, 12, and 24h + 1 sampling at either 10h or 16h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 2) Limited QD for participants 4 and higher: Pre-infusion and 1, 4, 6, and 8h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level; 3) BID: Pre-infusion and at 20 minutes and 1, 2.25, 3.25. 9, 12, and 24h post-infusion on Days 1 and 2 and on Days 8, 15, and 22 pre-infusion per dose level.
Blood samples for Vz/F were measured using liquid chromatography-tandem mass spectrometry and analyzed using a nonlinear mixed-effects modelling software program Monolix version 4.3.2. Results for each dose level and method of administration included participants from both AL and OHM cohorts and different regimen frequencies.
arm group label: AL 10 mg QD 14-21
arm group type: Experimental
description: Participants received 10 mg birabresib/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: AL 20 mg QD 14-21
arm group type: Experimental
description: Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: AL 40 mg QD 14-21
arm group type: Experimental
description: Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: AL 20 mg BID 21-21
arm group type: Experimental
description: Participants received 20 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
arm group label: AL 80 mg QD 14-21
arm group type: Experimental
description: Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: AL 40 mg BID 14-21
arm group type: Experimental
description: Participants received 40 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
arm group label: AL 120 mg QD 14-21
arm group type: Experimental
description: Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: AL 120 mg QD 21-21
arm group type: Experimental
description: Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
arm group label: AL 160 mg QD 14-21
arm group type: Experimental
description: Participants received 160 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: AML de novo 80 mg QD 14-21
arm group type: Experimental
description: Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: AML/MDS 80 mg QD 14-21
arm group type: Experimental
description: Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: OHM 10 mg QD 21-21
arm group type: Experimental
description: Participants received 10 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
arm group label: OHM 20 mg QD 21-21
arm group type: Experimental
description: Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
arm group label: OHM 40 mg QD 21-21
arm group type: Experimental
description: Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
arm group label: OHM 80 mg QD 21-21
arm group type: Experimental
description: Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
arm group label: OHM 40 mg BID 21-21
arm group type: Experimental
description: Participants received 40 mg birabresib/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
arm group label: OHM 120 mg QD 21-21
arm group type: Experimental
description: Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
arm group label: OHM 120 mg QD 14-21
arm group type: Experimental
description: Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
arm group label: OHM 120 mg QD 5-7
arm group type: Experimental
description: Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle.
arm group label: OHM 120 mg QD 7-21
arm group type: Experimental
description: Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle
arm group label: OHM/DLBCL 80 mg QD 14-21
arm group type: Experimental
description: Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
intervention type: Drug
intervention name: OTX015/Birabresib
description: OTX015/Birabresib 10 mg, 20 mg, or 40 mg capsules administered orally
arm group label: AL 10 mg QD 14-21
arm group label: AL 120 mg QD 14-21
arm group label: AL 120 mg QD 21-21
arm group label: AL 160 mg QD 14-21
arm group label: AL 20 mg BID 21-21
arm group label: AL 20 mg QD 14-21
arm group label: AL 40 mg BID 14-21
arm group label: AL 40 mg QD 14-21
arm group label: AL 80 mg QD 14-21
arm group label: AML de novo 80 mg QD 14-21
arm group label: AML/MDS 80 mg QD 14-21
arm group label: OHM 10 mg QD 21-21
arm group label: OHM 120 mg QD 14-21
arm group label: OHM 120 mg QD 21-21
arm group label: OHM 120 mg QD 5-7
arm group label: OHM 120 mg QD 7-21
arm group label: OHM 20 mg QD 21-21
arm group label: OHM 40 mg BID 21-21
arm group label: OHM 40 mg QD 21-21
arm group label: OHM 80 mg QD 21-21
arm group label: OHM/DLBCL 80 mg QD 14-21
other name: MK-8628
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
country: Canada
country: France
country: Italy
country: Switzerland
country: United Kingdom
citation: Odore E, Lokiec F, Cvitkovic E, Bekradda M, Herait P, Bourdel F, Kahatt C, Raffoux E, Stathis A, Thieblemont C, Quesnel B, Cunningham D, Riveiro ME, Rezai K. Phase I Population Pharmacokinetic Assessment of the Oral Bromodomain Inhibitor OTX015 in Patients with Haematologic Malignancies. Clin Pharmacokinet. 2016 Mar;55(3):397-405. doi: 10.1007/s40262-015-0327-6.
PMID: 26341814
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Multiple Myeloma
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Lymphoma, Large B-Cell, Diffuse
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 