<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01671007</url>
  </required_header>
  <id_info>
    <org_study_id>1160.136</org_study_id>
    <nct_id>NCT01671007</nct_id>
  </id_info>
  <brief_title>GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)</brief_title>
  <official_title>GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at&#xD;
      risk for stroke are enrolled to characterize the target population and to collect real world&#xD;
      data on important outcome events. For administrative purposes the study is divided into two&#xD;
      protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area)&#xD;
      countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in&#xD;
      both protocols is estimated to be 48,000 patients, and all these patients will be included in&#xD;
      the data analysis for study 1160.129.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 22, 2012</start_date>
  <completion_date type="Actual">December 13, 2019</completion_date>
  <primary_completion_date type="Actual">December 13, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death)</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Stroke or Systemic Embolism</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Stroke</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Transient Ischaemic Attack (TIA)</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Systemic Embolism (SEE)</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Pulmonary Embolism (PE)</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Major Bleeding Events</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Life-threatening Bleeding Events</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Vascular Death</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of Myocardial Infarction</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence Rate of All-cause Death</measure>
    <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
    <description>Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
  </primary_outcome>
  <enrollment type="Actual">10471</enrollment>
  <condition>Stroke</condition>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients with non-valvular AF&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Age =&gt;18 years at enrollment&#xD;
&#xD;
          2. Male or female patient (or legally acceptable representative) willing and able to&#xD;
             provide written informed consent&#xD;
&#xD;
          3. Patient newly diagnosed (&lt; 3 months prior to baseline visit) with non-valvular AF and&#xD;
             at risk for stroke.&#xD;
&#xD;
        Other inclusion criteria apply.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Presence of any mechanical heart valve, or valve disease that is expected to require&#xD;
             valve replacement intervention;&#xD;
&#xD;
          2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment&#xD;
             in their lifetime;&#xD;
&#xD;
          3. AF with a generally reversible cause;&#xD;
&#xD;
          4. Patients with a medical condition other than atrial fibrillation for which chronic use&#xD;
             of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria&#xD;
             apply&#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>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth</name>
      <address>
        <city>Bad Pirawarth</city>
        <zip>2222</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KH der Barmherzigen Schwestern Linz</name>
      <address>
        <city>Linz</city>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kepler Univ. Klinikum Linz</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ordination Dr. Martin Koschutnik, Oberwart</name>
      <address>
        <city>Oberwart</city>
        <zip>7400</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KH d. Barmherzigen Brüder Wien, Neurologie</name>
      <address>
        <city>Wien</city>
        <zip>1020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH - Medical University of Vienna</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Namur - HOSP St-Luc de Bouge</name>
      <address>
        <city>Bouge/Namur</city>
        <zip>5004</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Lucas</name>
      <address>
        <city>Brugge</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brussels - HOSP St-Jan</name>
      <address>
        <city>Brussel</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brussels - HOSP Europe (Ste-Elisabeth)</name>
      <address>
        <city>Brussel</city>
        <zip>1180</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ULB Hopital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg - Campus Sint-Jan</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liège - HOSP CHR de la Citadelle</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ottignies - HOSP St-Pierre</name>
      <address>
        <city>Ottignies</city>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tienen - PRAC De Wolf, Luc</name>
      <address>
        <city>Tienen</city>
        <zip>3300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Deva Maria&quot;, Dept. of Cardiology, Burgas</name>
      <address>
        <city>Burgas</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Dr.Stambolski&quot;, Cardiology&amp;Intensiv Care Dept,Kazanlak</name>
      <address>
        <city>Kazanlak</city>
        <zip>6100</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Sv.Georgi EAD</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT, Fourth Dept. of Internal Medicine, Rousse</name>
      <address>
        <city>Rousse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Akta Medika OOD, Sevlievo</name>
      <address>
        <city>Sevlievo</city>
        <zip>5400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment, Sliven</name>
      <address>
        <city>Sliven</city>
        <zip>8800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic &amp; Consultancy Center &quot;Ascendent&quot;, Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1202</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;National Cardiology Hosp.&quot; Cardiology Dept., Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1309</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital 'Alexandrovska', Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT, &quot;Vita&quot; Surgery Department, Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1505</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT &quot;Tsaritsa Yoanna-ISUL&quot; Clinic of Cardiology, Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT, Clinic of Cardiology, Stara Zagora</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6003</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Military Academy MHAT Varna</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol</name>
      <address>
        <city>Yambol</city>
        <zip>8600</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magdalena-Special Hosp.f.Cardiovas.Surgery,Krapinske Toplice</name>
      <address>
        <city>Krapinske Toplice</city>
        <zip>49217</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thalassoterapia,Rehab.of heart&amp;lung,Cardiology Clin, Opatija</name>
      <address>
        <city>Opatija</city>
        <zip>51410</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Split</name>
      <address>
        <city>Split</city>
        <zip>21000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hosp. Zadar, Clinic of Internal Med, Cardiology Dept</name>
      <address>
        <city>Zadar</city>
        <zip>23 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinic St. Luke, Cardiology Dept., Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Hosp. Sisters of Mercy, Cardiology Dept., Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital center Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>100 00</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital center Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Private Practice, Brno</name>
      <address>
        <city>Brno</city>
        <zip>61600</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Brno</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiocentrum, Private Practice, Kladno</name>
      <address>
        <city>Kladno</city>
        <zip>272 80</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Private Practice</name>
      <address>
        <city>Litovel</city>
        <zip>784 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Private Practice, Praha</name>
      <address>
        <city>Praha 5</city>
        <zip>15005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Private Practice, Roznov pod Radhostem</name>
      <address>
        <city>Roznov pod Radhostem</city>
        <zip>756 61</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forskningens Hus</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydvestjysk Sygehus Esbjerg, Hjertemedicinsk afd.</name>
      <address>
        <city>Esbjerg</city>
        <zip>6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev and Gentofte Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordsjællands Hospital - Hillerød</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kolding Sygehus</name>
      <address>
        <city>Kolding</city>
        <zip>6000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Estonia Med.Centre,Internal Med.Clin/Cardiology,Tallin</name>
      <address>
        <city>Tallinn</city>
        <zip>134 19</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tallinn Central Hospital</name>
      <address>
        <city>Tallin</city>
        <zip>10138</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Général, Cardio, Abbeville</name>
      <address>
        <city>Abbeville</city>
        <zip>80142</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP d'Agen, Cardio, Agen</name>
      <address>
        <city>Agen</city>
        <zip>47923</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP d'Aix en Provence, cardio, Aix-en-Provence</name>
      <address>
        <city>Aix en Provence</city>
        <zip>13616</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Général, Cardio, Abbeville</name>
      <address>
        <city>Aix en Provence</city>
        <zip>13616</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Louis Pasteur, Cardio, Bagnols sur Ceze</name>
      <address>
        <city>Bagnols sur Ceze</city>
        <zip>30205</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Bar le Duc, Pneumo, Bar le Duc</name>
      <address>
        <city>Bar le Duc</city>
        <zip>55012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP de Bayonne</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Berdagué P, Cardio, Beziers</name>
      <address>
        <city>Beziers</city>
        <zip>34500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Breton Dr Nicolas</name>
      <address>
        <city>Beziers</city>
        <zip>34500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI Tivoli</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Saint-André</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Ambroise Paré</name>
      <address>
        <city>Boulogne-Billancourt</city>
        <zip>92104</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Fleyriat, GERIA, Bourg-en-Bresse</name>
      <address>
        <city>Bour-en-Bresse</city>
        <zip>01012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP de la Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI les Cedres, Cardio, Brive La Gaillarde</name>
      <address>
        <city>Brive La Gaillarde</city>
        <zip>19100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Cadinot Dr D, Broglie</name>
      <address>
        <city>Broglie</city>
        <zip>27270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Frappé T, MG, BRUAY LA BUISSIERE</name>
      <address>
        <city>Bruay la Buissière</city>
        <zip>62700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP de Béziers</name>
      <address>
        <city>Béziers</city>
        <zip>34525</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Saint Martin, cardio, Caen</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Brunschwig, Cardio, Cannes</name>
      <address>
        <city>Cannes</city>
        <zip>06400</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP William Morey, Cardio, Chalon-Sur-Saône</name>
      <address>
        <city>Chalon-Sur-Saône</city>
        <zip>71100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Loiselet P</name>
      <address>
        <city>Cherbourg</city>
        <zip>50100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Gabriel-Montpied</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Brunehaut M, Cardio, Clermont Ferrand</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Sud Francilien</name>
      <address>
        <city>Corbeil Essonnes</city>
        <zip>91106</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Sud Francilien, Cardio, Corbeil-Essonnes</name>
      <address>
        <city>Corbeil-Essonnes</city>
        <zip>91106</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <zip>94000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Bocage</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Louis Pasteur, Cardio, Dole</name>
      <address>
        <city>Dole</city>
        <zip>39108</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CTRE Evecquemont, Cardio, Evecquemont</name>
      <address>
        <city>Evecquemont</city>
        <zip>78740</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP du Val d'Ariège, Cardio, Foix</name>
      <address>
        <city>Foix</city>
        <zip>09107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Michallon</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Benhalima B, Cardio, Le bourget</name>
      <address>
        <city>Le Bourget</city>
        <zip>93350</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP André Mignot</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Louis Pasteur, Cardio, Le Coudray</name>
      <address>
        <city>Le Coudray</city>
        <zip>28630</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Le Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Phan Cao Phai, Cardio, Levallois Perret</name>
      <address>
        <city>Levallois Perret</city>
        <zip>92300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI Libournais, Cardio, Libourne</name>
      <address>
        <city>Libourne</city>
        <zip>33500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Robert Boulin, cardio, Libourne</name>
      <address>
        <city>Libourne</city>
        <zip>33500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI de la Louviere</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI le Colombier, Cardio, Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP St Joseph-St Luc, Cardio, Lyon</name>
      <address>
        <city>Lyon cedex 7</city>
        <zip>69365</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Gartenlaub O, Cardio, Maison Alfort</name>
      <address>
        <city>Maisons Alfort</city>
        <zip>94700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Timone</name>
      <address>
        <city>Marseille cedex 5</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB, Salem A, Cardio, Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Européen</name>
      <address>
        <city>Marseille</city>
        <zip>13003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Scala P-J</name>
      <address>
        <city>Marseille</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Scemama J</name>
      <address>
        <city>Marseille</city>
        <zip>13008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB vial, Cardio, Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP des Rayettes</name>
      <address>
        <city>Martigues</city>
        <zip>13698</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP de la région d'Annecy, Cardio, Metz-Tessy</name>
      <address>
        <city>Metz-Tessy</city>
        <zip>74370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Dillinger J, MG, Mondelange</name>
      <address>
        <city>Mondelange</city>
        <zip>57300</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI de Montargis, Cardio, Montargis</name>
      <address>
        <city>Montargis</city>
        <zip>45200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI du Pont de Chaume</name>
      <address>
        <city>Montauban</city>
        <zip>82000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Raincy Montfermeil, Cardio, Montfermeil</name>
      <address>
        <city>Montfermeil</city>
        <zip>93370</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Prunier L, Cardio, Montreuil</name>
      <address>
        <city>Montreuil</city>
        <zip>93100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Central, Neuro, Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54035</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP de Courbevoie, Spécialités Med, Neuilly sur Seine</name>
      <address>
        <city>Neuilly sur Seine</city>
        <zip>92200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Jamon Y, Cardio, Nîmes</name>
      <address>
        <city>Nimes</city>
        <zip>30000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Carémeau</name>
      <address>
        <city>Nîmes</city>
        <zip>3000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI Les Franciscaines, cardio, Nïmes</name>
      <address>
        <city>Nïmes</city>
        <zip>30032</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Orléans, Cardio, Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Audouin P, Cardio, Paris</name>
      <address>
        <city>Paris</city>
        <zip>75007</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI Turin, Cardio, Paris</name>
      <address>
        <city>Paris</city>
        <zip>75008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Cohen S, Paris</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Poulain F, Paris</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Européen G. Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Pontchaillou</name>
      <address>
        <city>Rennes Cedex</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Duvilla N, Cardio, Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Dascotte O, Cardio, St André lez Lille</name>
      <address>
        <city>Saint André lez Lille</city>
        <zip>59350</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Lequeux B, Cardio, Saint Benoit</name>
      <address>
        <city>Saint Benoit</city>
        <zip>86280</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Privé de la Loire, Cardio, Saint Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Dary P, Cardio, St-Yrieix-la-Perche</name>
      <address>
        <city>Saint-Yrieix-la-Perche</city>
        <zip>87500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Tessier P, Cardio, St Raphael</name>
      <address>
        <city>St Raphael</city>
        <zip>83700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Muller J-J, Cardio, Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI de l'Ormeau, Cardio, Tarbes</name>
      <address>
        <city>Tarbes</city>
        <zip>65000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Houppe Nousse MP, Cardio, Thionville</name>
      <address>
        <city>Thionville</city>
        <zip>57100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP du Léman</name>
      <address>
        <city>Thonon-les-bains</city>
        <zip>74203</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Sainte Musse</name>
      <address>
        <city>Toulon</city>
        <zip>83100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Rangueil</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Cardio, Tourcoing</name>
      <address>
        <city>Tourcoing</city>
        <zip>59200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Leprince P, MG, Tours</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Trousseau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLI Village de Santé, Cardio, Trélaze</name>
      <address>
        <city>Trelaze</city>
        <zip>49804</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Valence, Cardio, Valence</name>
      <address>
        <city>Valence</city>
        <zip>26000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Bretagne Atlantique, Cardio, Vannes</name>
      <address>
        <city>Vannes</city>
        <zip>56017</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Lejay D, MG, Vieux Condé</name>
      <address>
        <city>Vieux Condé</city>
        <zip>59690</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAB Schaupp T, MG, Vihiers</name>
      <address>
        <city>Vihiers</city>
        <zip>49310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bezirkskrankenhaus, Ansbach</name>
      <address>
        <city>Ansbach</city>
        <zip>91522</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff-Klinik, Bad Nauheim</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologische Klinik GmbH, Bad Neustadt</name>
      <address>
        <city>Bad Neustadt/Saale</city>
        <zip>97616</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sozialstiftung Bamberg</name>
      <address>
        <city>Bamberg</city>
        <zip>96046</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelisches Elisabeth-Krankenhaus, Berlin Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10785</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Rieker, Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10789</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10967</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>12351</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Altmann, Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12489</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxisgemeinschaft Dres. Weinrich</name>
      <address>
        <city>Berlin</city>
        <zip>12555</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Claus, 10969 Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12559</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Praxis Dr. Jochen Bott</name>
      <address>
        <city>Berlin</city>
        <zip>13405</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13505</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13509</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vivantes Netzwerk für Gesundheit GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13585</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gesundheit Nord gGmbH | Klinikverbund Bremen</name>
      <address>
        <city>Bremen</city>
        <zip>28177</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Bremerhaven</name>
      <address>
        <city>Bremerhaven</city>
        <zip>27574</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Gefaesszentrum am Neumarkt</name>
      <address>
        <city>Celle</city>
        <zip>29221</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis Dr. med. J. Sek, Chemnitz</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Coburg gGmbH</name>
      <address>
        <city>Coburg</city>
        <zip>96450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HELIOS Amper Kliniken, Dachau</name>
      <address>
        <city>Dachau</city>
        <zip>85221</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Praxisgemeinschaft,Darmstadt</name>
      <address>
        <city>Darmstadt</city>
        <zip>64287</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Rybak, Dessau</name>
      <address>
        <city>Dessau-Roßlau</city>
        <zip>06847</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Lippe-Detmold GmbH</name>
      <address>
        <city>Detmold</city>
        <zip>32756</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologischen Gemeinschaftspraxis Dinslaken</name>
      <address>
        <city>Dinslaken</city>
        <zip>46535</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Bernhard-Paul Lodde</name>
      <address>
        <city>Dortmund</city>
        <zip>44147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxisklinik Herz und Gefäße</name>
      <address>
        <city>Dresden</city>
        <zip>01099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Evangelisches Krankenhaus Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40217</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Esslingen GmbH</name>
      <address>
        <city>Esslingen</city>
        <zip>73730</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für Herz-Kreislauf-Erkrankungen Zeulenroda-Greiz</name>
      <address>
        <city>Greiz</city>
        <zip>07973</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Geort</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Harburg</name>
      <address>
        <city>Hamburg</city>
        <zip>21075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Barmbek</name>
      <address>
        <city>Hamburg</city>
        <zip>22291</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Herz im Zentrum Laske</name>
      <address>
        <city>Hannover</city>
        <zip>30159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Ingolstadt GmbH</name>
      <address>
        <city>Ingolstadt</city>
        <zip>85049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Mibach, Itzehoe</name>
      <address>
        <city>Itzehoe</city>
        <zip>25524</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>07740</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Gemeinschaftspraxis Kassel</name>
      <address>
        <city>Kassel</city>
        <zip>34117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Frickel Siegfried</name>
      <address>
        <city>Kempen</city>
        <zip>47906</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Matthias Gabelmann</name>
      <address>
        <city>Kirchzarten</city>
        <zip>79199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius-Hospital, Kleve</name>
      <address>
        <city>Kleve</city>
        <zip>47533</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis für Kardiologie, Köln</name>
      <address>
        <city>Köln</city>
        <zip>51105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig GmbH</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Leverkusen gGmbH, Leverkusen</name>
      <address>
        <city>Leverkusen</city>
        <zip>51375</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardio Centrum Ludwigsburg</name>
      <address>
        <city>Ludwigsburg</city>
        <zip>71634</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Stadt Ludwigshafen am Rhein gGmbH</name>
      <address>
        <city>Ludwigshafen</city>
        <zip>67063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Magdeburg A. ö. R.</name>
      <address>
        <city>Magdeburg</city>
        <zip>39120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinsachftspraxis Regner/Schmitt/Kros, Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr.med. Jens Taggeselle, Markkleeberg</name>
      <address>
        <city>Markkleeberg</city>
        <zip>04416</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Memmingen</name>
      <address>
        <city>Memmingen</city>
        <zip>87700</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johannes Wesling Klinikum</name>
      <address>
        <city>Minden</city>
        <zip>32429</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Maria Hilf GmbH</name>
      <address>
        <city>Moenchengladbach</city>
        <zip>41063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Norbert Schön, Mühldorf</name>
      <address>
        <city>Mühldorf</city>
        <zip>84453</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum ALTER HOF München</name>
      <address>
        <city>München</city>
        <zip>80331</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der Technischen Universität München</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>45129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Joachim Gmehling</name>
      <address>
        <city>Nürnberg</city>
        <zip>90402</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Osnabrück GmbH</name>
      <address>
        <city>Osnabrueck</city>
        <zip>49076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincenz-Krankenhaus GmbH</name>
      <address>
        <city>Paderborn</city>
        <zip>33098</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Praxis Papenburg</name>
      <address>
        <city>Papenburg</city>
        <zip>26871</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologisches Zentrum Peine</name>
      <address>
        <city>Peine</city>
        <zip>31224</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städt. Krankenhaus, Pforzheim</name>
      <address>
        <city>Pforzheim</city>
        <zip>75175</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Gemeinschaftspraxis Potsdam</name>
      <address>
        <city>Potsdam</city>
        <zip>14471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Gemeinschaftspraxis Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18057</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kreisklinikum Siegen GmbH</name>
      <address>
        <city>Siegen</city>
        <zip>57076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Berufsausübungsgemeinschaft Klein /Kratochvil</name>
      <address>
        <city>Stuttgart</city>
        <zip>70178</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzklinik Ulm Gemeinschaftspraxis</name>
      <address>
        <city>Ulm</city>
        <zip>89077</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schwarzwald-Baar Klinikum</name>
      <address>
        <city>Villingen-Schwenningen</city>
        <zip>78011</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Praxis, Wermsdorf</name>
      <address>
        <city>Wermsdorf</city>
        <zip>04779</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedKonsil, Wiesbaden</name>
      <address>
        <city>Wiesbaden</city>
        <zip>65189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Gemeinschaftspraxis Wittenberg</name>
      <address>
        <city>Wittenberg</city>
        <zip>06886</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Alexandroupolis</name>
      <address>
        <city>Alexandroupoli</city>
        <zip>68100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euroclinic of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11521</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Korgialeneio-Benakeio&quot; Hellenic Red Cross Hospital</name>
      <address>
        <city>Athens</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sotiria Hosp.,Hypertension Unit,3rd Clinic of Internal Med.</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asclepion Voulas Hospital, Cardiological Clinic</name>
      <address>
        <city>Athens</city>
        <zip>16673</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Chalkida</name>
      <address>
        <city>Chalkida</city>
        <zip>34100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Chania</name>
      <address>
        <city>Chania</city>
        <zip>73100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Edessa, Cardiology Clinic</name>
      <address>
        <city>Edessa</city>
        <zip>58200</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gen. Hosp. of Elefsina &quot;Thriassio&quot;</name>
      <address>
        <city>Elefsina</city>
        <zip>19600</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Heraklion</name>
      <address>
        <city>Herakleion, Crete</city>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Gen. Hosp. of Ioannina</name>
      <address>
        <city>Ioannina</city>
        <zip>45500</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Komotinis</name>
      <address>
        <city>Komotini</city>
        <zip>69100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital of Larissa</name>
      <address>
        <city>Larissa</city>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Patras Medical School</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Rhodes</name>
      <address>
        <city>Rhodes</city>
        <zip>85100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gen. Hosp. of Thessaloniki &quot;Hippokation&quot;, Cardiology Clinic</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54642</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Papageorgiou&quot; General Hospital of Thessaloniki, B' Cardiolo</name>
      <address>
        <city>Thessaloniki</city>
        <zip>56429</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Panarkadiko Hospital of Tripolis, Cardiology Clinic</name>
      <address>
        <city>Tripoli</city>
        <zip>22100</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Portiuncula Hospital</name>
      <address>
        <city>Ballinasloe</city>
        <zip>H53 T971</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's Hospital</name>
      <address>
        <city>Dublin 8</city>
        <zip>Dublin 8</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adelaide &amp; Meath Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>24</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Galway</name>
      <address>
        <city>Galway</city>
        <zip>GALWAY</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Redhouse Family Practice</name>
      <address>
        <city>Mallow</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Riuniti Albano Genzano</name>
      <address>
        <city>Albano Laziale</city>
        <zip>00041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. S.M. di Misericordia</name>
      <address>
        <city>Albenga</city>
        <zip>17031</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Ospedaliere Umberto I di Ancona</name>
      <address>
        <city>Ancona</city>
        <zip>60020</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Reg Umberto Parini</name>
      <address>
        <city>Aosta</city>
        <zip>11100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale C. G. Mazzoni</name>
      <address>
        <city>Ascoli Piceno</city>
        <zip>63100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ. Osp. Assisi U.O.</name>
      <address>
        <city>Assisi</city>
        <zip>06081</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. SS Filippo Nicola</name>
      <address>
        <city>Avezzano</city>
        <zip>67051</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Bari</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario di Bari</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico S. Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. O. G. Brotzu</name>
      <address>
        <city>Cagliari</city>
        <zip>09134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero di Castrovillari</name>
      <address>
        <city>Castrovillari (CS)</city>
        <zip>87012</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P. O. &quot;Garibaldi&quot; - Nesima</name>
      <address>
        <city>Catania</city>
        <zip>95122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Univ. Vittorio Ferrarotto S. Bambino</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Mater Domini, Universita di Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. Clin. SS. Anunziata</name>
      <address>
        <city>Chieti</city>
        <zip>66013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Arcispedale Sant'Anna</name>
      <address>
        <city>Cona (FE)</city>
        <zip>44124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp.S.Salvatore</name>
      <address>
        <city>Coppitto (AQ)</city>
        <zip>67100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ. Osped. Ospedale Maggiore di Crema</name>
      <address>
        <city>Crema (CR)</city>
        <zip>26013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. Istituti Osp. di Cremona</name>
      <address>
        <city>Cremona</city>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Biagio</name>
      <address>
        <city>Domodossola (VB)</city>
        <zip>28845</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P. O. S. Maria Nuova</name>
      <address>
        <city>Firenze</city>
        <zip>50122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Careggi</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Careggi</name>
      <address>
        <city>Firenze</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az.Osp. Universitaria &quot;Ospedali Riuniti&quot;</name>
      <address>
        <city>Foggia</city>
        <zip>71100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Cuore di Gesù</name>
      <address>
        <city>Gallipoli</city>
        <zip>73014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico San Martino</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale della Misericordia</name>
      <address>
        <city>Grosseto</city>
        <zip>58100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale F. Veneziale</name>
      <address>
        <city>Isernia</city>
        <zip>86170</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera C. Poma</name>
      <address>
        <city>Mantova</city>
        <zip>46100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. Pediatrico Aprano Pasquinucci</name>
      <address>
        <city>Massa</city>
        <zip>54100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az Osp. Amico &quot; Gaetano Fucito&quot;</name>
      <address>
        <city>Mercato San Severino (SA)</city>
        <zip>84085</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Cardiologico Monzino-IRCCS</name>
      <address>
        <city>Milano</city>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nuovo Ospedale Civile S. Agostino-Estense</name>
      <address>
        <city>Modena</city>
        <zip>46100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp.Riun.Valdichiana Senese</name>
      <address>
        <city>Montepulciano Senese (SI)</city>
        <zip>53045</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. San Gerardo di Monza</name>
      <address>
        <city>Monza (MB)</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Nuovo Pellegrini</name>
      <address>
        <city>Napoli</city>
        <zip>80134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Cardarelli</name>
      <address>
        <city>Napoli</city>
        <zip>80135</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp.Sacro Cuore-Don Calabria</name>
      <address>
        <city>Negrar (VR)</city>
        <zip>37024</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. San Giacomo</name>
      <address>
        <city>Novi Ligure</city>
        <zip>15067</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. San Francesco</name>
      <address>
        <city>Nuoro</city>
        <zip>08100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Ospedale S. Luigi Gonzaga</name>
      <address>
        <city>Orbassano (TO)</city>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Univ. Policlinico Giaccone</name>
      <address>
        <city>Palermo</city>
        <zip>90129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico S. Matteo</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S.Maria della Misericordia, AO di Perugia</name>
      <address>
        <city>Perugia</city>
        <zip>06156</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Salvatore</name>
      <address>
        <city>Pesaro</city>
        <zip>6121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osp. Guglielmo da Saliceto AUSL di Piacenza</name>
      <address>
        <city>Piacenza</city>
        <zip>29121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese</name>
      <address>
        <city>Pietra Ligure</city>
        <zip>17027</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Cisanello</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S.Tommaso dei Battuti</name>
      <address>
        <city>Portogruaro (VE)</city>
        <zip>30026</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P.O.S. Maria Grazie</name>
      <address>
        <city>Pozzuoli</city>
        <zip>80078</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Unità Sanitaria Locale di Reggio Emilia</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>12100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;Giambattista Grassi</name>
      <address>
        <city>Roma</city>
        <zip>00122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pol. Universitario Tor Vergata</name>
      <address>
        <city>Roma</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Complessa Ospedaliera Ospedale San Fiippo Neri</name>
      <address>
        <city>Roma</city>
        <zip>00135</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;S. Eugenio&quot;</name>
      <address>
        <city>Roma</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. San Camillo Forlanini</name>
      <address>
        <city>Roma</city>
        <zip>00151</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umberto I Pol. di Roma-Università di Roma La Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Casilino U.O. Cardiologia</name>
      <address>
        <city>Roma</city>
        <zip>00169</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp.Madre Giuseppina Vannini-</name>
      <address>
        <city>Roma</city>
        <zip>00177</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. S.Giovanni-Addolorata</name>
      <address>
        <city>Roma</city>
        <zip>00184</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Spirito</name>
      <address>
        <city>Roma</city>
        <zip>00193</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nuovo Ospedale Civile di Sassuolo</name>
      <address>
        <city>Sassuolo</city>
        <zip>41049</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Gruppo Multimedica</name>
      <address>
        <city>Sesto S.Giovanni (MI)</city>
        <zip>20090</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Senese Policlinico Santa Maria alle Scotte</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AO Città della Salute e della</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mauriziano di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO</name>
      <address>
        <city>Treviso</city>
        <zip>31100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. O. S. Maria della Misericordia</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A. O. Ospedale Circolo Fond. Macchi</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Bortolo</name>
      <address>
        <city>Vicenza</city>
        <zip>36100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liepaja Regional Hospital, Therapy Department</name>
      <address>
        <city>Liepaja</city>
        <zip>3414</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P.Stradins Clin.Univ.Hosp,Cardio.Diagnos&amp;Outpatient Dep,Riga</name>
      <address>
        <city>Riga</city>
        <zip>1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga East University Hospital</name>
      <address>
        <city>Riga</city>
        <zip>1038</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis-Hertogenbosch</name>
      <address>
        <city>'s HERTOGENBOSCH</city>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC, Locatie AMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rijnstate Hospital</name>
      <address>
        <city>Arnhem</city>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IJsselland Ziekenhuis</name>
      <address>
        <city>Capelle Aan Den Ijssel</city>
        <zip>2906 ZC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf Groep</name>
      <address>
        <city>Delft</city>
        <zip>2625 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Noordwest Ziekenhuisgroep</name>
      <address>
        <city>Den Helder</city>
        <zip>1782 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deventer Ziekenhuis</name>
      <address>
        <city>Deventer</city>
        <zip>7416 SE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Van Weel-Bethesda Ziekenhuis</name>
      <address>
        <city>Dirksland</city>
        <zip>3247 BW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <zip>7512KZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medisch Centrum</name>
      <address>
        <city>Heerlen</city>
        <zip>6419 PC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TREANT zorggroep</name>
      <address>
        <city>Hoogeveen</city>
        <zip>7909 AA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westfries Gasthuis</name>
      <address>
        <city>Hoorn</city>
        <zip>1624 NP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius ziekenhuis, locatie Nieuwegein</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Havenziekenhuis</name>
      <address>
        <city>Rotterdam</city>
        <zip>3011 TD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medisch Centrum</name>
      <address>
        <city>Sittard - Geleen</city>
        <zip>6162 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antonius Ziekenhuis</name>
      <address>
        <city>Sneek</city>
        <zip>8601 ZK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Rivierenland</name>
      <address>
        <city>Tiel</city>
        <zip>4002 WP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VieCuri Medisch Centrum, locatie Venray</name>
      <address>
        <city>Venray</city>
        <zip>5801 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Zwolle</name>
      <address>
        <city>Zwolle</city>
        <zip>8011 JW</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Legegruppen Arendal</name>
      <address>
        <city>Arendal</city>
        <zip>N-4836</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vestre Viken HF, Bærum sykehus</name>
      <address>
        <city>Drammen</city>
        <zip>N-3004</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisinsk Senter Fornebu DA</name>
      <address>
        <city>Fornebu</city>
        <zip>N-1364</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vestre Viken, Ringerike Sykehus HF</name>
      <address>
        <city>Hønefoss</city>
        <zip>N-3511</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Innlandet HF, Kongsvinger</name>
      <address>
        <city>Kongsvinger</city>
        <zip>N-2212</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sykehuset Innlandet HF, Avd. Lillehammer</name>
      <address>
        <city>Lillehammer</city>
        <zip>N-2629</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Volvat Medisinske senter, Oslo</name>
      <address>
        <city>Oslo</city>
        <zip>N-0370</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitetssykehuset Nord-Norge, Tromsø</name>
      <address>
        <city>Tromsø</city>
        <zip>N-9038</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Clinic Hosp, Bialystok</name>
      <address>
        <city>Bialystok</city>
        <zip>15276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice Jacek Kowalczyk, Bytom</name>
      <address>
        <city>Bytom</city>
        <zip>41902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialist Out-patient Clinics 'Na Gornej',Cieszyn</name>
      <address>
        <city>Cieszyn</city>
        <zip>43400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialistic Cardiology&amp;Hypertension Out-patient Clin,Kielce</name>
      <address>
        <city>Kielce</city>
        <zip>25525</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice of Heart Diseases Malgorzata Lelonek,Lodz</name>
      <address>
        <city>Lodz</city>
        <zip>90727</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allmedica Sp. z.o.o, prac. Nowy Targ</name>
      <address>
        <city>Nowy Targ</city>
        <zip>34400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Specialistic Practices, Nysa</name>
      <address>
        <city>Nysa</city>
        <zip>48300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reg.Hosp, Intern.Med.Ward w/ Intensive Cardiol.Care, Opoczno</name>
      <address>
        <city>Opoczno</city>
        <zip>26300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny w Pulawach</name>
      <address>
        <city>Pulawy</city>
        <zip>24-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Out-patient Clinic &quot;Cardio-Plus&quot;, Radlin</name>
      <address>
        <city>Radlin</city>
        <zip>44144</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Internal Medicine,Cardiol.practiceWanda&amp;Jerzy Sudnik,Sokolka</name>
      <address>
        <city>Sokolka</city>
        <zip>16100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Individual Specialist.Private Practice Dr.W.Krysiak,Szczecin</name>
      <address>
        <city>Szczecin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Individual Specialistic Private Practice,Dr.A.Tomasik,Zabrze</name>
      <address>
        <city>Zabrze</city>
        <zip>41800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slaskie Center Heart Disease SUM,Cardiol.&amp;Electr.Clin.Zabrze</name>
      <address>
        <city>Zabrze</city>
        <zip>41800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Garcia de Orta, EPE</name>
      <address>
        <city>Almada</city>
        <zip>2805-267</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHLO, EPE - Hospital de Santa Cruz</name>
      <address>
        <city>Carnaxide</city>
        <zip>2799-523</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã</name>
      <address>
        <city>Covilhã</city>
        <zip>6200-251</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Algarve, EPE</name>
      <address>
        <city>Faro</city>
        <zip>8000-386</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHULN, EPE - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1064-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHLO, EPE - Hospital S. Francisco Xavier</name>
      <address>
        <city>Lisboa</city>
        <zip>1449-005</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Luz</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHULN, EPE - Hospital de Santa Maria</name>
      <address>
        <city>Lisboa</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário São João,EPE</name>
      <address>
        <city>Porto</city>
        <zip>4202-451</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Santiago</name>
      <address>
        <city>Setúbal</city>
        <zip>2900-722</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Espírito Santo, EPE</name>
      <address>
        <city>Évora</city>
        <zip>7000-811</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMI Dr. Bogdan Minescu, Braila</name>
      <address>
        <city>Braila</city>
        <zip>810262</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency University Hospital, Bucharest</name>
      <address>
        <city>Bucharest</city>
        <zip>050098</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ILRO Medical SRL, Bucharest</name>
      <address>
        <city>Bucharest</city>
        <zip>10628</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med.Centre Diagnosis,Treatm&amp;Prev Med.Cardiol.Dept, Bucharest</name>
      <address>
        <city>Bucharest</city>
        <zip>11792</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Titan Medical SRL, Bucharest</name>
      <address>
        <city>Bucharest</city>
        <zip>21323</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Humanitas Medical Center, Bucharest</name>
      <address>
        <city>Bucharest</city>
        <zip>62272</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Cardiomed SRL, Cluj Napoca</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Cardiomed SRL, Constanta</name>
      <address>
        <city>Constanta</city>
        <zip>900704</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>S.C Cardiomed S.R.L</name>
      <address>
        <city>Craiova</city>
        <zip>200147</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Cardiomed SRL, Iasi</name>
      <address>
        <city>Iasi</city>
        <zip>700034</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Galenus Medical Center, Targu Mures</name>
      <address>
        <city>Targu Mures</city>
        <zip>540099</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicorclinics, Timisoara</name>
      <address>
        <city>Timisoara</city>
        <zip>300014</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Celje</name>
      <address>
        <city>Celje</city>
        <zip>3000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Medical Centre Ljubljana, Dept. of Vascular Diseases</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Passeig de Maragall</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Lucía</name>
      <address>
        <city>Cartagena (Murcia)</city>
        <zip>30202</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Consultorio Cañaveral</name>
      <address>
        <city>Cañaveral (Cáceres)</city>
        <zip>10820</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Princesa</name>
      <address>
        <city>Cáceres</city>
        <zip>10820</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Reina Sofía</name>
      <address>
        <city>Córdoba</city>
        <zip>14004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar - Murcia</city>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario San Cecilio</name>
      <address>
        <city>Granada</city>
        <zip>18012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Jerez de la Frontera</name>
      <address>
        <city>Jerez De La Frontera - Cádiz</city>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Gran Canaria Dr. Negrín</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <zip>35010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Severo Ochoa</name>
      <address>
        <city>Leganes - Madrid</city>
        <zip>28911</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de León</name>
      <address>
        <city>Leon</city>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de León</name>
      <address>
        <city>León</city>
        <zip>24071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucus Augusti</name>
      <address>
        <city>Lugo</city>
        <zip>27004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Jazmin</name>
      <address>
        <city>Madrid</city>
        <zip>28033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Salud Isla de Oza</name>
      <address>
        <city>Madrid</city>
        <zip>28035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Málaga</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Costa del Sol</name>
      <address>
        <city>Marbella . Málaga</city>
        <zip>29603</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Son Llàtzer</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>San Juan de Alicante</city>
        <zip>03550</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Moises Broggi</name>
      <address>
        <city>Sant Joan Despi</city>
        <zip>08970</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Juan de Dios</name>
      <address>
        <city>Sevilla</city>
        <zip>41005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ABP Salud Sevilla</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nuestra Señora de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CS Ingeniero Joaquin Benlloch</name>
      <address>
        <city>Valencia</city>
        <zip>46006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Meixoeiro</name>
      <address>
        <city>Vigo</city>
        <zip>36200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Povisa</name>
      <address>
        <city>Vigo</city>
        <zip>36211</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Comarcal Axarquía</name>
      <address>
        <city>Vélez-Málaga</city>
        <zip>29700</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Falu lasarett</name>
      <address>
        <city>Falun</city>
        <zip>791 82</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska Universitetssjukhuset, Östra</name>
      <address>
        <city>Göteborg</city>
        <zip>416 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skånes universitetssjukhus, Malmö</name>
      <address>
        <city>Malmö</city>
        <zip>205 02</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stockholm Heart Center AB</name>
      <address>
        <city>Stockholm</city>
        <zip>111 35</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Danderyds Sjukhus</name>
      <address>
        <city>Stockholm</city>
        <zip>182 88</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norrlands Universitetssjukhus</name>
      <address>
        <city>Umeå</city>
        <zip>901 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrallasarettet, Västerås</name>
      <address>
        <city>Västerås</city>
        <zip>721 89</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gale Farm Surgery</name>
      <address>
        <city>Acomb</city>
        <zip>YO24 3BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William Harvey Hospital</name>
      <address>
        <city>Ashford</city>
        <zip>TN24 0LZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Axbridge and Wedmore Medical Practice</name>
      <address>
        <city>Axbridge</city>
        <zip>BS26 2BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basildon University Hospital</name>
      <address>
        <city>Basildon</city>
        <zip>SS16 5NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Hampshire Hospital</name>
      <address>
        <city>Basingstoke</city>
        <zip>RG24 9NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospital</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beehive Surgery</name>
      <address>
        <city>Bath</city>
        <zip>BA2 1NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham City Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B18 7QH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth and Christchurch Hospital</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford on Avon Health Centre</name>
      <address>
        <city>Bradford on Avon</city>
        <zip>BA15 1DQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradgate Surgery</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 6SP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Infirmary</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clevedon Riverside Group</name>
      <address>
        <city>Bristol</city>
        <zip>BS21 6DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burbage Surgery</name>
      <address>
        <city>Burbage, Hinkley</city>
        <zip>LE10 2SE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Suffolk Hospital</name>
      <address>
        <city>Bury St Edmunds</city>
        <zip>IP33 2QZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumberland Infirmary</name>
      <address>
        <city>Carlisle</city>
        <zip>CA2 7HY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Countess of Chester Hospital</name>
      <address>
        <city>Chester</city>
        <zip>CH2 1UL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castle Hill Hopsital</name>
      <address>
        <city>Cottingham</city>
        <zip>HU16 5JQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pound Hill Medical Group</name>
      <address>
        <city>Crawley</city>
        <zip>RH10 7DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dorset County Hospital</name>
      <address>
        <city>Dorchester</city>
        <zip>DT1 2JY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russells Hall Hospital</name>
      <address>
        <city>Dudley</city>
        <zip>DY1 2HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital &amp; Medical School</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Durham</name>
      <address>
        <city>Durham</city>
        <zip>DH1 5TW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Royal Hospital</name>
      <address>
        <city>Gloucester</city>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The County Hospital</name>
      <address>
        <city>Hereford</city>
        <zip>HR1 2ER</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wycombe General Hospital</name>
      <address>
        <city>High Wycombe</city>
        <zip>HP11 2TT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Honiton Surgery Group - Seamark</name>
      <address>
        <city>Honiton</city>
        <zip>EX14 2NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hedon Group Practice</name>
      <address>
        <city>Hull</city>
        <zip>HU12 8JD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Airedale General Hospital</name>
      <address>
        <city>Keighley</city>
        <zip>BD20 6TD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmorland General Hospital</name>
      <address>
        <city>Kendal</city>
        <zip>LA9 7RG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sherbourne Medical Centre</name>
      <address>
        <city>Leamington Spa</city>
        <zip>CV32 4RA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds General Infirmary</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Unit, Liverpool Heart and Chest Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L14 3PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aintree University Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altnagelvin Area Hospital</name>
      <address>
        <city>Londonderry</city>
        <zip>BT47 6SB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Lewisham</name>
      <address>
        <city>London</city>
        <zip>SE13 6LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>London</city>
        <zip>SW17 0RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luton and Dunstable University Hospital</name>
      <address>
        <city>Luton</city>
        <zip>LU4 0DZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Chad's Surgery</name>
      <address>
        <city>Midsomer Norton</city>
        <zip>BA3 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northampton General Hospital</name>
      <address>
        <city>Northampton</city>
        <zip>NN1 5BD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Eliot Hospital</name>
      <address>
        <city>Nuneaton</city>
        <zip>CV10 7DJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Oldham Hospital</name>
      <address>
        <city>Oldham</city>
        <zip>OL1 2JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perth Royal Infirmary</name>
      <address>
        <city>Perth</city>
        <zip>PH1 1NX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peterborough City Hospital</name>
      <address>
        <city>Peterborough</city>
        <zip>PE3 9GZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poole Hospital</name>
      <address>
        <city>Poole</city>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Craigavon Area Hospital</name>
      <address>
        <city>Portadown, County Atrim</city>
        <zip>BT63 5QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Preston Hospital</name>
      <address>
        <city>Preston</city>
        <zip>PR2 9HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire Hospital</name>
      <address>
        <city>Reading</city>
        <zip>RG1 5AN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandra Hospital</name>
      <address>
        <city>Redditch</city>
        <zip>B98 7UB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Cornwall Surgery</name>
      <address>
        <city>Saint Just, Penzance</city>
        <zip>TR19 7HX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salisbury District Hospital</name>
      <address>
        <city>Salisbury</city>
        <zip>SP2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Shrewsbury Hospital</name>
      <address>
        <city>Shrewsbury</city>
        <zip>SY3 8XQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wexham Park Hospital</name>
      <address>
        <city>Slough</city>
        <zip>SL2 4HL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Conquest Hospital</name>
      <address>
        <city>St Leonards on Sea</city>
        <zip>TN37 7RD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>County Hospital</name>
      <address>
        <city>Stafford</city>
        <zip>ST16 3SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Branch End Surgery</name>
      <address>
        <city>Stocksfield</city>
        <zip>NE43 7LL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunderland Royal Hospital</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's Mill Hospital</name>
      <address>
        <city>Sutton in Ashfield</city>
        <zip>NG17 4JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singleton Hospital</name>
      <address>
        <city>Swansea</city>
        <zip>SA2 8QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Musgrove Park Hospital</name>
      <address>
        <city>Taunton</city>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torbay Hospital</name>
      <address>
        <city>Torquay</city>
        <zip>TQ2 7AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Tyneside District Hospital</name>
      <address>
        <city>Tyne-and-Wear</city>
        <zip>NE34 0PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillingdon Hospital</name>
      <address>
        <city>Uxbridge</city>
        <zip>UB8 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wansford Surgery</name>
      <address>
        <city>Wansford, Peterborough</city>
        <zip>PE8 6PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Avenue Surgery</name>
      <address>
        <city>Warminster</city>
        <zip>BA12 9AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Warwick Hospital</name>
      <address>
        <city>Warwick</city>
        <zip>CV34 5BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth II Hospital</name>
      <address>
        <city>Welwyn Garden City</city>
        <zip>AL7 4HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westbury Group Practice</name>
      <address>
        <city>Westbury</city>
        <zip>BA13 3FQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southend General Hospital</name>
      <address>
        <city>Westcliffe-on-Sea</city>
        <zip>SS0 0RY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Whitby Group Practice</name>
      <address>
        <city>Whitby</city>
        <zip>YO21 1SD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrowe Park Hospital</name>
      <address>
        <city>Wirral</city>
        <zip>CH49 5PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jorvik Medical Practice</name>
      <address>
        <city>York</city>
        <zip>YO1 7NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Medical Group</name>
      <address>
        <city>York</city>
        <zip>YO24 4HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The York Hospital</name>
      <address>
        <city>York</city>
        <zip>YO31 8HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MyHealth, Strensall Health Care Centre</name>
      <address>
        <city>York</city>
        <zip>YO32 5UA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Latvia</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Slovenia</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
    <country>El Salvador</country>
    <country>Lithuania</country>
  </removed_countries>
  <link>
    <url>https://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <results_first_submitted>December 7, 2020</results_first_submitted>
  <results_first_submitted_qc>December 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 31, 2020</results_first_posted>
  <last_update_submitted>December 7, 2020</last_update_submitted>
  <last_update_submitted_qc>December 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2020</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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 22, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT01671007/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT01671007/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study investigated characteristics of patients with non-valvular atrial fibrillation influencing the choice of antithrombotic treatment for the prevention of stroke, and the safety and effectiveness of dabigatran versus Vitamin K Antagonist for up to 3-year follow-up period.</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility prior to participation in the study. Subjects attended a participating site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Dabigatran Etexilate - Baseline</title>
          <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P2">
          <title>Vitamin K Antagonist (VKA) - Baseline</title>
          <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P3">
          <title>Rivaroxaban - Baseline</title>
          <description>Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P4">
          <title>Apixaban - Baseline</title>
          <description>Patients who were prescribed Apixaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P5">
          <title>Edoxaban - Baseline</title>
          <description>Patients who were prescribed Edoxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P6">
          <title>Acetylsalicylic Acid (ASA) - Baseline</title>
          <description>Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P7">
          <title>Antiplts Other Than ASA - Baseline</title>
          <description>Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P8">
          <title>No Treatment - Baseline</title>
          <description>Patients who were prescribed no treatment at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="P9">
          <title>Combinations With Oral Anticoagulants - Baseline</title>
          <description>Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients were not included in the safety analysis as no specific treatment can be defined.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2089"/>
                <participants group_id="P2" count="2834"/>
                <participants group_id="P3" count="2033"/>
                <participants group_id="P4" count="2214"/>
                <participants group_id="P5" count="180"/>
                <participants group_id="P6" count="513"/>
                <participants group_id="P7" count="80"/>
                <participants group_id="P8" count="526"/>
                <participants group_id="P9" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>All Eligible</title>
              <participants_list>
                <participants group_id="P1" count="2066"/>
                <participants group_id="P2" count="2758"/>
                <participants group_id="P3" count="2008"/>
                <participants group_id="P4" count="2197"/>
                <participants group_id="P5" count="180"/>
                <participants group_id="P6" count="507"/>
                <participants group_id="P7" count="79"/>
                <participants group_id="P8" count="507"/>
                <participants group_id="P9" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1768"/>
                <participants group_id="P2" count="2183"/>
                <participants group_id="P3" count="1667"/>
                <participants group_id="P4" count="1846"/>
                <participants group_id="P5" count="155"/>
                <participants group_id="P6" count="401"/>
                <participants group_id="P7" count="59"/>
                <participants group_id="P8" count="394"/>
                <participants group_id="P9" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="321"/>
                <participants group_id="P2" count="651"/>
                <participants group_id="P3" count="366"/>
                <participants group_id="P4" count="368"/>
                <participants group_id="P5" count="25"/>
                <participants group_id="P6" count="112"/>
                <participants group_id="P7" count="21"/>
                <participants group_id="P8" count="132"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other reasons than listed</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
                <participants group_id="P2" count="373"/>
                <participants group_id="P3" count="197"/>
                <participants group_id="P4" count="228"/>
                <participants group_id="P5" count="14"/>
                <participants group_id="P6" count="71"/>
                <participants group_id="P7" count="17"/>
                <participants group_id="P8" count="66"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="59"/>
                <participants group_id="P3" count="53"/>
                <participants group_id="P4" count="58"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="15"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="19"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="93"/>
                <participants group_id="P2" count="142"/>
                <participants group_id="P3" count="91"/>
                <participants group_id="P4" count="63"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="20"/>
                <participants group_id="P7" count="2"/>
                <participants group_id="P8" count="28"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No end of study case report form</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not eligible</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="76"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="19"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All eligible: All patients who were enrolled and eligible (i.e. did not have any important. protocol violation(s) and who met certain data cleaning requirements).</population>
      <group_list>
        <group group_id="B1">
          <title>Dabigatran Etexilate - Baseline</title>
          <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B2">
          <title>Vitamin K Antagonist (VKA) - Baseline</title>
          <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B3">
          <title>Rivaroxaban - Baseline</title>
          <description>Patients who were prescribed Rivaroxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B4">
          <title>Apixaban - Baseline</title>
          <description>Patients who were prescribed Apixaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B5">
          <title>Edoxaban - Baseline</title>
          <description>Patients who were prescribed Edoxaban at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B6">
          <title>Acetylsalicylic Acid (ASA) - Baseline</title>
          <description>Patients who were prescribed Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B7">
          <title>Antiplts Other Than ASA - Baseline</title>
          <description>Patients who were prescribed Antiplts other than Acetylsalicylic acid (ASA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B8">
          <title>No Treatment - Baseline</title>
          <description>Patients who were prescribed no treatment at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B9">
          <title>Combinations With Oral Anticoagulants - Baseline</title>
          <description>Patients who were prescribed the treatments with combinations with oral anticoagulants at baseline were included in this group. This group of patients were not included in the safety analysis as no specific treatment can be defined.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
        </group>
        <group group_id="B10">
          <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="2066"/>
            <count group_id="B2" value="2758"/>
            <count group_id="B3" value="2008"/>
            <count group_id="B4" value="2197"/>
            <count group_id="B5" value="180"/>
            <count group_id="B6" value="507"/>
            <count group_id="B7" value="79"/>
            <count group_id="B8" value="507"/>
            <count group_id="B9" value="2"/>
            <count group_id="B10" value="10304"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.3" spread="9.4"/>
                    <measurement group_id="B2" value="72.8" spread="9.5"/>
                    <measurement group_id="B3" value="71.1" spread="10.1"/>
                    <measurement group_id="B4" value="73.3" spread="9.8"/>
                    <measurement group_id="B5" value="73.3" spread="9.2"/>
                    <measurement group_id="B6" value="70.5" spread="12.4"/>
                    <measurement group_id="B7" value="74.2" spread="11.1"/>
                    <measurement group_id="B8" value="68.7" spread="12.5"/>
                    <measurement group_id="B9" value="71.5" spread="0.7"/>
                    <measurement group_id="B10" value="72.0" spread="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="942"/>
                    <measurement group_id="B2" value="1252"/>
                    <measurement group_id="B3" value="894"/>
                    <measurement group_id="B4" value="990"/>
                    <measurement group_id="B5" value="86"/>
                    <measurement group_id="B6" value="234"/>
                    <measurement group_id="B7" value="25"/>
                    <measurement group_id="B8" value="246"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="4670"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1124"/>
                    <measurement group_id="B2" value="1506"/>
                    <measurement group_id="B3" value="1114"/>
                    <measurement group_id="B4" value="1207"/>
                    <measurement group_id="B5" value="94"/>
                    <measurement group_id="B6" value="273"/>
                    <measurement group_id="B7" value="54"/>
                    <measurement group_id="B8" value="261"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="5634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian/Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1792"/>
                    <measurement group_id="B2" value="2526"/>
                    <measurement group_id="B3" value="1735"/>
                    <measurement group_id="B4" value="1835"/>
                    <measurement group_id="B5" value="178"/>
                    <measurement group_id="B6" value="430"/>
                    <measurement group_id="B7" value="75"/>
                    <measurement group_id="B8" value="482"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="9055"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="254"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="253"/>
                    <measurement group_id="B4" value="339"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="71"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="22"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death)</title>
        <description>Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death)</title>
          <description>Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" lower_limit="1.86" upper_limit="2.73"/>
                    <measurement group_id="O2" value="3.02" lower_limit="2.54" upper_limit="3.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.64</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)</title>
        <description>Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)</title>
          <description>Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.91" lower_limit="1.52" upper_limit="2.32"/>
                    <measurement group_id="O2" value="2.36" lower_limit="1.93" upper_limit="2.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.70</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
            <estimate_desc>Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Stroke or Systemic Embolism</title>
        <description>Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Stroke or Systemic Embolism</title>
          <description>Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" lower_limit="0.45" upper_limit="0.94"/>
                    <measurement group_id="O2" value="1.01" lower_limit="0.76" upper_limit="1.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
            <estimate_desc>Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Stroke</title>
        <description>Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Stroke</title>
          <description>Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" lower_limit="0.42" upper_limit="0.89"/>
                    <measurement group_id="O2" value="0.96" lower_limit="0.70" upper_limit="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
            <estimate_desc>Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Transient Ischaemic Attack (TIA)</title>
        <description>Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Transient Ischaemic Attack (TIA)</title>
          <description>Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" lower_limit="0.16" upper_limit="0.47"/>
                    <measurement group_id="O2" value="0.26" lower_limit="0.12" upper_limit="0.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Systemic Embolism (SEE)</title>
        <description>Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Systemic Embolism (SEE)</title>
          <description>Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" lower_limit="0.00" upper_limit="0.16"/>
                    <measurement group_id="O2" value="0.06" lower_limit="0.00" upper_limit="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Pulmonary Embolism (PE)</title>
        <description>Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Pulmonary Embolism (PE)</title>
          <description>Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" lower_limit="0.02" upper_limit="0.18"/>
                    <measurement group_id="O2" value="0.06" lower_limit="0.00" upper_limit="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Major Bleeding Events</title>
        <description>Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Major Bleeding Events</title>
          <description>Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.73" lower_limit="0.49" upper_limit="0.98"/>
                    <measurement group_id="O2" value="1.42" lower_limit="1.09" upper_limit="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, abnormal kidney function, concomitant antiplatelets use and concomitant use of drugs related to bleeding.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>0.88</ci_upper_limit>
            <estimate_desc>Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Life-threatening Bleeding Events</title>
        <description>Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Life-threatening Bleeding Events</title>
          <description>Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" lower_limit="0.31" upper_limit="0.71"/>
                    <measurement group_id="O2" value="1.04" lower_limit="0.77" upper_limit="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Vascular Death</title>
        <description>Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Vascular Death</title>
          <description>Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" lower_limit="0.51" upper_limit="1.02"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.73" upper_limit="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Myocardial Infarction</title>
        <description>Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Myocardial Infarction</title>
          <description>Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" lower_limit="0.18" upper_limit="0.53"/>
                    <measurement group_id="O2" value="0.45" lower_limit="0.27" upper_limit="0.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous myocardial infarction, concomitant antiplatelets use, concomitant use of drugs related to bleeding, hypertension, and diabetes.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>1.84</ci_upper_limit>
            <estimate_desc>Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of All-cause Death</title>
        <description>Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
        <time_frame>From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.</time_frame>
        <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Dabigatran Etexilate - Baseline</title>
            <description>Patients who were prescribed Dabigatran etexilate at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Vitamin K Antagonist (VKA) - Baseline</title>
            <description>Patients who were prescribed Vitamin K Antagonist (VKA) at baseline were included in this group. Patients can take other Antithrombotic treatments later during the study.&#xD;
Patients who were newly diagnosed non-valvular Atrial Fibrillation (AF) less than 3 months before the baseline visits (less than 4.5 months before baseline visit for Latin America) and who were at risk for stroke in a real-life setting. Antithrombotic treatments were used according to local practice for stroke prevention. The choice of antithrombotic agent and dosing was at the discretion of the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of All-cause Death</title>
          <description>Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.</description>
          <population>Restricted patient set: the set consists of all eligible patients who were within the region of propensity score (PS) overlap excluding patients in the non-overlapping tails of the propensity score distribution. The restricted patient set was defined for dabigatran etexilate and vitamin K antagonist patients only.</population>
          <units>Events per 100 person-years</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1946"/>
                <count group_id="O2" value="2509"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.08" lower_limit="1.69" upper_limit="2.51"/>
                    <measurement group_id="O2" value="3.27" lower_limit="2.80" upper_limit="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A multivariable Cox regression model was performed including variables of treatment, age, gender, prior bleed, previous stroke/transient ischaemic attack/systemic embolism, previous myocardial infarction, abnormal kidney function and concomitant antiplatelets use.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.60</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
            <estimate_desc>Hazard ratio of dabigatran versus vitamin K antagonist (vitamin K antagonist as reference).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline visit until study completion or discontinuation, up to 3 years of follow-up.</time_frame>
      <desc>Enrolled and treated: All patients entered in the electronic data capture system who signed the informed consent and treated with at least once with the study treatments. Patients who were prescribed the combinations of oral anticoagulants at enrollment were excluded as no specific treatment can be defined for this group. For patients from the 'No treatment-initial' group, only their adverse events that happened when receiving certain treatment were reported in the respective treatment group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dabigatran Etexilate - at Least Once During the Study</title>
          <description>All patients received at least once dabigatran etexilate during the study were included in the group. Adverse events which happened when the patients received dabigatran etexilate were reported in this group.&#xD;
Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.</description>
        </group>
        <group group_id="E2">
          <title>Vitamin K Antagonist (VKA) - at Least Once During the Study</title>
          <description>All patients received at least once Vitamin K Antagonist (VKA) during the study were included in the group. Adverse events which happened when the patients received Vitamin K Antagonist (VKA) were reported in this group.&#xD;
Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.</description>
        </group>
        <group group_id="E3">
          <title>Rivaroxaban - at Least Once During the Study</title>
          <description>All patients received at least once Rivaroxaban during the study were included in the group. Adverse events which happened when the patients received Rivaroxaban were reported in this group.&#xD;
Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.</description>
        </group>
        <group group_id="E4">
          <title>Apixaban - at Least Once During the Study</title>
          <description>All patients received at least once Apixaban during the study were included in the group. Adverse events which happened when the patients received Apixaban were reported in this group.&#xD;
Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.</description>
        </group>
        <group group_id="E5">
          <title>Edoxaban - at Least Once During the Study</title>
          <description>All patients received at least once Edoxaban during the study were included in the group. Adverse events which happened when the patients received Edoxaban were reported in this group.&#xD;
Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse event happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.</description>
        </group>
        <group group_id="E6">
          <title>Acetylsalicylic Acid (ASA) - at Least Once During the Study</title>
          <description>All patients received at least once Acetylsalicylic acid (ASA) during the study were included in the group. Adverse events which happened when the patients received Acetylsalicylic acid (ASA) were reported in this group.&#xD;
Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.</description>
        </group>
        <group group_id="E7">
          <title>Antiplts Other Than ASA - at Least Once During the Study</title>
          <description>All patients received at least once Antiplts other than Acetylsalicylic acid (ASA) during the study were included in the group. Adverse events which happened when the patients received Antiplts other than ASA were reported in this group.&#xD;
Patients can take any Antithrombotic treatments during the study. Adverse events were reported in the treatment group a patient actually received when the adverse events happened. Hence, the treatment groups in the adverse events section are not mutually exclusive.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="116" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="264" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="166" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="207" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="17" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="141" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="33" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="79" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="157" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="92" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="99" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="70" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="427"/>
              </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="4" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Hypochromic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Splenic haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Hypertensive cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Retinal artery embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Barrett's oesophagus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Discoloured vomit</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastroduodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Mallory-Weiss syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Mesenteric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Peptic ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Peritoneal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Retroperitoneal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Vomiting projectile</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </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="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Medical device site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Puncture site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Suprapubic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Diverticulitis intestinal haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Extradural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Splenic injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Subcutaneous haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Traumatic haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Traumatic haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Traumatic renal injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Bleeding time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Occult blood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </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="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haematoma muscle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Muscle haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Basal ganglia haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cerebellar haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cerebellar stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cerebral haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemorrhagic transformation stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Intracranial haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Vascular dementia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemorrhage urinary tract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Hypertensive nephropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Renal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Renal infarct</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Urogenital haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Respiratory tract haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Arterial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Embolism arterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Peripheral embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Subgaleal haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Venous haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2385"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3258"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="2576"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2934"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="368"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="1940"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="427"/>
              </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>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.&#xD;
Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.&#xD;
BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The data used in this analysis included only patients participating in Phase III of this study. Patients participating in Phase II were reported and analyzed in the 1160.129 phase II report, and were not planned to be reported separately for 1160.136.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.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/NCT01671007
org study id: 1160.136
nct id: NCT01671007
lead sponsor: 
In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at
      risk for stroke are enrolled to characterize the target population and to collect real world
      data on important outcome events. For administrative purposes the study is divided into two
      protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area)
      countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in
      both protocols is estimated to be 48,000 patients, and all these patients will be included in
      the data analysis for study 1160.129.
observational model: Cohort
time perspective: Prospective
measure: Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death)
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
measure: Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death)
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate.
measure: Incidence Rate of Stroke or Systemic Embolism
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
measure: Incidence Rate of Stroke
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification.
measure: Incidence Rate of Transient Ischaemic Attack (TIA)
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
measure: Incidence Rate of Systemic Embolism (SEE)
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
measure: Incidence Rate of Pulmonary Embolism (PE)
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
measure: Incidence Rate of Major Bleeding Events
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding.
measure: Incidence Rate of Life-threatening Bleeding Events
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding.
measure: Incidence Rate of Vascular Death
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
measure: Incidence Rate of Myocardial Infarction
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
measure: Incidence Rate of All-cause Death
time frame: From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
description: Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Austria
country: Belgium
country: Bulgaria
country: Croatia
country: Czechia
country: Denmark
country: Estonia
country: France
country: Germany
country: Greece
country: Ireland
country: Italy
country: Latvia
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Romania
country: Slovenia
country: Spain
country: Sweden
country: United Kingdom
country: Czech Republic
country: El Salvador
country: Lithuania
url: https://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Atrial Fibrillation
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The data used in this analysis included only patients participating in Phase III of this study. Patients participating in Phase II were reported and analyzed in the 1160.129 phase II report, and were not planned to be reported separately for 1160.136.
point of contact: 