<?xml version="1.0" encoding="UTF-8"?>
<aev:adverseEvents xmlns:aev="http://eudract.ema.europa.eu/schema/clinical_trial_result/adverse_events" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
  <description>AE additional description</description>
  <nonSeriousEventFrequencyThreshold>0.0</nonSeriousEventFrequencyThreshold>
  <timeFrame>Timeframe for AE</timeFrame>
  <assessmentMethod>
    <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
  </assessmentMethod>
  <dictionary>
    <otherName xsi:nil="true"/>
    <version>19.0</version>
    <name>
      <value>ADV_EVT_DICTIONARY_NAME.meddra</value>
    </name>
  </dictionary>
  <reportingGroups>
    <reportingGroup id="idm664008912">
      <title>Control</title>
      <description xsi:nil="true"/>
      <subjectsAffectedByNonSeriousAdverseEvents>15</subjectsAffectedByNonSeriousAdverseEvents>
      <subjectsAffectedBySeriousAdverseEvents>15</subjectsAffectedBySeriousAdverseEvents>
      <subjectsExposed>99</subjectsExposed>
      <deathsAllCauses>12</deathsAllCauses>
      <deathsResultingFromAdverseEvents>9</deathsResultingFromAdverseEvents>
    </reportingGroup>
    <reportingGroup id="idm664007248">
      <title>Experimental</title>
      <description xsi:nil="true"/>
      <subjectsAffectedByNonSeriousAdverseEvents>24</subjectsAffectedByNonSeriousAdverseEvents>
      <subjectsAffectedBySeriousAdverseEvents>33</subjectsAffectedBySeriousAdverseEvents>
      <subjectsExposed>101</subjectsExposed>
      <deathsAllCauses>27</deathsAllCauses>
      <deathsResultingFromAdverseEvents>22</deathsResultingFromAdverseEvents>
    </reportingGroup>
  </reportingGroups>
  <nonSeriousAdverseEvents>
    <nonSeriousAdverseEvent>
      <description>Acute coronary syndrome</description>
      <term>Acute coronary syndrome</term>
      <organSystem>
        <eutctId>100000004849</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Intestinal perforation</description>
      <term>Intestinal perforation</term>
      <organSystem>
        <eutctId>100000004856</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Laryngeal stenosis</description>
      <term>Laryngeal stenosis</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Lower respiratory tract infection</description>
      <term>Lower respiratory tract infection</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Lung adenocarcinoma</description>
      <term>Lung adenocarcinoma</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Pneumonia</description>
      <term>Pneumonia</term>
      <organSystem>
        <eutctId>100000004862</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>2</occurrences>
          <subjectsAffected>2</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>4</occurrences>
          <subjectsAffected>3</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Pneumonia</description>
      <term>Pneumonia</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Pneumonitis</description>
      <term>Pneumonitis</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Pyrexia</description>
      <term>Pyrexia</term>
      <organSystem>
        <eutctId>100000004867</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Renal impairment</description>
      <term>Renal impairment</term>
      <organSystem>
        <eutctId>100000004857</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Respiratory tract infection</description>
      <term>Respiratory tract infection</term>
      <organSystem>
        <eutctId>100000004862</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>2</occurrences>
          <subjectsAffected>2</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Sleep apnoea syndrome</description>
      <term>Sleep apnoea syndrome</term>
      <organSystem>
        <eutctId>100000004852</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>2</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Squamous cell carcinoma</description>
      <term>Squamous cell carcinoma</term>
      <organSystem>
        <eutctId>100000004864</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
    <nonSeriousAdverseEvent>
      <description>Vasculitis</description>
      <term>Vasculitis</term>
      <organSystem>
        <eutctId>100000004870</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>4</occurrences>
          <subjectsAffected>3</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>3</occurrences>
          <subjectsAffected>3</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
        </value>
      </values>
    </nonSeriousAdverseEvent>
  </nonSeriousAdverseEvents>
  <seriousAdverseEvents>
    <seriousAdverseEvent>
      <description>Abdominal pain</description>
      <term>Abdominal pain</term>
      <organSystem>
        <eutctId>100000004856</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Aortic valve replacement</description>
      <term>Aortic valve replacement</term>
      <organSystem>
        <eutctId>100000004865</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>B-cell lymphoma</description>
      <term>B-cell lymphoma</term>
      <organSystem>
        <eutctId>100000004851</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Bladder papilloma</description>
      <term>Bladder papilloma</term>
      <organSystem>
        <eutctId>100000004864</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Cardiac arrest</description>
      <term>Cardiac arrest</term>
      <organSystem>
        <eutctId>100000004849</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>1</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Cardiac failure congestive</description>
      <term>Cardiac failure congestive</term>
      <organSystem>
        <eutctId>100000004849</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Cellulitis</description>
      <term>Cellulitis</term>
      <organSystem>
        <eutctId>100000004862</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>1</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>1</deaths>
            <deathsCausallyRelatedToTreatment>1</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Cerebrovascular accident</description>
      <term>Cerebrovascular accident</term>
      <organSystem>
        <eutctId>100000004852</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
      </assessmentMethod>
      <dictionaryOverridden>false</dictionaryOverridden>
      <values>
        <value reportingGroupId="idm664008912">
          <occurrences>1</occurrences>
          <subjectsAffected>1</subjectsAffected>
          <subjectsExposed>99</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>1</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
        <value reportingGroupId="idm664007248">
          <occurrences>0</occurrences>
          <subjectsAffected>0</subjectsAffected>
          <subjectsExposed>101</subjectsExposed>
          <occurrencesCausallyRelatedToTreatment>0</occurrencesCausallyRelatedToTreatment>
          <fatalities>
            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Chest pain</description>
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    <seriousAdverseEvent>
      <description>Cholecystectomy</description>
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    <seriousAdverseEvent>
      <description>Cholecystitis acute</description>
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    <seriousAdverseEvent>
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      <description>Escherichia urinary tract infection</description>
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      <description>Fall</description>
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    <seriousAdverseEvent>
      <description>Gastroenteritis Escherichia coli</description>
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      <description>Gastroenteritis viral</description>
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      <description>Medical observation</description>
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      <description>Oesophageal spasm</description>
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          <fatalities>
            <deaths>1</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Oesophagitis</description>
      <term>Oesophagitis</term>
      <organSystem>
        <eutctId>100000004856</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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      <dictionaryOverridden>false</dictionaryOverridden>
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            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
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            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Pneumomediastinum</description>
      <term>Pneumomediastinum</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
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            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Pneumonia</description>
      <term>Pneumonia</term>
      <organSystem>
        <eutctId>100000004862</eutctId>
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      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
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          <subjectsAffected>3</subjectsAffected>
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            <deaths>1</deaths>
            <deathsCausallyRelatedToTreatment>1</deathsCausallyRelatedToTreatment>
          </fatalities>
        </value>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Pneumonia klebsiella</description>
      <term>Pneumonia klebsiella</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
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      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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      <dictionaryOverridden>false</dictionaryOverridden>
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            <deaths>0</deaths>
            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
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            <deaths>1</deaths>
            <deathsCausallyRelatedToTreatment>1</deathsCausallyRelatedToTreatment>
          </fatalities>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Pneumonia staphylococcal</description>
      <term>Pneumonia staphylococcal</term>
      <organSystem>
        <eutctId>100000004855</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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            <deaths>1</deaths>
            <deathsCausallyRelatedToTreatment>1</deathsCausallyRelatedToTreatment>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Pneumonia viral</description>
      <term>Pneumonia viral</term>
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      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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            <deaths>1</deaths>
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            <deaths>0</deaths>
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          </fatalities>
        </value>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Post procedural complication</description>
      <term>Post procedural complication</term>
      <organSystem>
        <eutctId>100000004863</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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            <deathsCausallyRelatedToTreatment>0</deathsCausallyRelatedToTreatment>
          </fatalities>
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            <deaths>1</deaths>
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          </fatalities>
        </value>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Proteinuria</description>
      <term>Proteinuria</term>
      <organSystem>
        <eutctId>100000004857</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
        <value>ADV_EVT_ASSESS_TYPE.non_systematic</value>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Pulmonary embolism</description>
      <term>Pulmonary embolism</term>
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      <assessmentMethod>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Pulmonary embolism</description>
      <term>Pulmonary embolism</term>
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        <eutctId>100000004866</eutctId>
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      </organSystem>
      <assessmentMethod>
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    <seriousAdverseEvent>
      <description>Pulmonary vasculitis</description>
      <term>Pulmonary vasculitis</term>
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        <eutctId>100000004870</eutctId>
        <version>19</version>
      </organSystem>
      <assessmentMethod>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Respiratory tract infection</description>
      <term>Respiratory tract infection</term>
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      </organSystem>
      <assessmentMethod>
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          </fatalities>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Sleep apnoea syndrome</description>
      <term>Sleep apnoea syndrome</term>
      <organSystem>
        <eutctId>100000004852</eutctId>
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      <assessmentMethod>
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    </seriousAdverseEvent>
    <seriousAdverseEvent>
      <description>Small intestinal resection</description>
      <term>Small intestinal resection</term>
      <organSystem>
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      <assessmentMethod>
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      <description>Urinary tract infection</description>
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          </fatalities>
        </value>
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    </seriousAdverseEvent>
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      <description>Vasculitis</description>
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          </fatalities>
        </value>
      </values>
    </seriousAdverseEvent>
  </seriousAdverseEvents>
</aev:adverseEvents>
