<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/NCT02226120</url>
  </required_header>
  <id_info>
    <org_study_id>CLCZ696B2317</org_study_id>
    <secondary_id>2014-001971-30</secondary_id>
    <nct_id>NCT02226120</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction</brief_title>
  <official_title>A Multicenter Study to Evaluate Safety and Tolerability in Patients With Chronic Heart Failure and Reduced Ejection Fraction From PARADIGM-HF Receiving Open Label LCZ696</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible&#xD;
      PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF&#xD;
      (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients&#xD;
      with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified&#xD;
      interim analysis in March 2014.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2014</start_date>
  <completion_date type="Actual">December 28, 2017</completion_date>
  <primary_completion_date type="Actual">December 28, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696</measure>
    <time_frame>From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.</time_frame>
    <description>The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1980</enrollment>
  <condition>Chronic Heart Failure With Reduced Ejection Fraction</condition>
  <arm_group>
    <arm_group_label>LCZ696</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LCZ696</intervention_name>
    <description>Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid</description>
    <arm_group_label>LCZ696</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent for the extension must be obtained before any assessment is&#xD;
             performed.&#xD;
&#xD;
          2. Patients who have completed PARADIGM-HF (protocol CLCZ696B2314) and are able to be&#xD;
             safely enrolled into the open-label trial as judged by the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5&#xD;
             half-lives of enrollment, whichever is longer&#xD;
&#xD;
          2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar&#xD;
             chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected&#xD;
             contraindications to LCZ696&#xD;
&#xD;
          3. Known history of angioedema&#xD;
&#xD;
          4. Requirement of simultaneous treatment with both ACEIs and ARBs&#xD;
&#xD;
          5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and&#xD;
             symptoms that may require intravenous therapy)&#xD;
&#xD;
          6. Symptomatic hypotension and/or a SBP &lt; 100 mmHg at Visit 1 (screening)&#xD;
&#xD;
          7. Estimated GFR &lt; 30 mL/min/1.73m^2 as measured by the simplified MDRD formula at Visit&#xD;
             1 (screening)&#xD;
&#xD;
          8. Presence of bilateral renal artery stenosis&#xD;
&#xD;
          9. Serum potassium &gt; 5.2 mmol/L at Visit 1 (screening)&#xD;
&#xD;
         10. Evidence of hepatic disease as determined by any one of the following: AST or ALT&#xD;
             values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of&#xD;
             esophageal varices, or history of portacaval shunt&#xD;
&#xD;
         11. Pregnant or nursing (lactating) women&#xD;
&#xD;
         12. Women of child-bearing potential&#xD;
&#xD;
         13. Any condition, not identified in the protocol, that in the opinion of the investigator&#xD;
             is likely to prevent the patient from safely tolerating LCZ696 or complying with the&#xD;
             requirements of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muscle Shoals</city>
        <state>Alabama</state>
        <zip>35662</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <zip>92056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95405</zip>
        <country>United States</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33472-2952</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
      <address>
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        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <state>Nebraska</state>
        <zip>68025</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>New York</state>
        <zip>11422</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
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        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Ohio</state>
        <zip>43302</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Texas</state>
        <zip>75251</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Texas</state>
        <zip>77351</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
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        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
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      <name>Novartis Investigative Site</name>
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        <state>Wisconsin</state>
        <zip>53188</zip>
        <country>United States</country>
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  <location>
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      <name>Novartis Investigative Site</name>
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        <state>Buenos Aires</state>
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        <country>Argentina</country>
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        <country>Argentina</country>
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        <state>Buenos Aires</state>
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      <name>Novartis Investigative Site</name>
      <address>
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        <state>Capital Federal</state>
        <zip>C1179AAB</zip>
        <country>Argentina</country>
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      <name>Novartis Investigative Site</name>
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        <state>Jujuy</state>
        <zip>Y4600ABF</zip>
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        <state>Provincia De Salta</state>
        <zip>A4406BPF</zip>
        <country>Argentina</country>
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        <state>Santa Fe</state>
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        <country>Argentina</country>
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        <country>Belgium</country>
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        <zip>7100</zip>
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        <country>Brazil</country>
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        <country>Brazil</country>
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        <country>Brazil</country>
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        <state>PE</state>
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        <country>Brazil</country>
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        <state>RJ</state>
        <zip>22280-020</zip>
        <country>Brazil</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <state>RS</state>
        <zip>90880-480</zip>
        <country>Brazil</country>
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    <facility>
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      <address>
        <city>Marilia</city>
        <state>SP</state>
        <zip>17515-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>SP</state>
        <zip>14055-370</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santo Andre</city>
        <state>SP</state>
        <zip>09190-615</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sao Jose do Rio Preto</city>
        <state>SP</state>
        <zip>15015-750</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01323 000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Votuporanga</city>
        <state>SP</state>
        <zip>15500-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Haskovo</city>
        <zip>6300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shumen</city>
        <zip>9700</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sofia</city>
        <zip>1309</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8R4R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <zip>N2M 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Weston</city>
        <state>Ontario</state>
        <zip>M9N 1W4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Levis</city>
        <state>Quebec</state>
        <zip>G6V 4Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St-Georges Beauce</city>
        <state>Quebec</state>
        <zip>G5Y 4T8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Temuco</city>
        <state>Araucania</state>
        <zip>4780000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Beroun</city>
        <state>Czech Republic</state>
        <zip>266 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brandys nad Labem</city>
        <state>Czech Republic</state>
        <zip>250 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Liberec V Kristianova</city>
        <state>Czech Republic</state>
        <zip>460 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Olomouc</city>
        <state>Czech Republic</state>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Prague 10, Vrsovice</city>
        <state>Czech Republic</state>
        <zip>10100</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Trebic</city>
        <state>Czech Republic</state>
        <zip>674 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bilovec</city>
        <state>CZE</state>
        <zip>743 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kolin</city>
        <zip>280 20</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Prague 5</city>
        <zip>150 30</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Praha</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Uherske Hradiste</city>
        <zip>68601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Esbjerg</city>
        <zip>DK-6700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hellerup</city>
        <zip>DK-2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Randers</city>
        <zip>8930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Svendborg</city>
        <zip>5700</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Viborg</city>
        <zip>DK-8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tartu</city>
        <zip>50410</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montpellier cedex 5</city>
        <state>Herault</state>
        <zip>34059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dresden</city>
        <state>Sachsen</state>
        <zip>01099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bad Homburg</city>
        <zip>61348</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin-Buch</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>10369</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13405</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dessau-Roßlau</city>
        <zip>06846</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dresden</city>
        <zip>01309</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Elsterwerda</city>
        <zip>04910</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>60488</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>65929</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>22291</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>22765</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Huy / OT Anderbeck</city>
        <zip>38836</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ingelheim</city>
        <zip>55218</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kelkheim</city>
        <zip>65779</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Koethen</city>
        <zip>06366</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Künzelsau</city>
        <zip>74653</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04129</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04315</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Loehne</city>
        <zip>32584</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muehldorf</city>
        <zip>84453</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muehlheim An Der Ruhr</city>
        <zip>45468</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Offenbach</city>
        <zip>63073</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wermsdorf</city>
        <zip>04779</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wetzlar-Naunheim</city>
        <zip>35584</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Weyhe</city>
        <zip>28844</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala</city>
        <state>Ciudad</state>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <zip>01015</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hong Kong SAR</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hong Kong</city>
        <zip>HONG KONG</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1096</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1122</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>1145</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nyiregyháza</city>
        <zip>4400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Szekesfehervar</city>
        <zip>H-8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Szekszard</city>
        <zip>7100</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Zalaegerszeg</city>
        <zip>8900</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guntur</city>
        <state>Andhra Pradesh</state>
        <zip>522001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dehli</city>
        <state>Delhi</state>
        <zip>110080</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380 051</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gujarat</state>
        <zip>380054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Anand</city>
        <state>Gujarat</state>
        <zip>388325</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395 002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Surat</city>
        <state>Gujrat</state>
        <zip>395002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vadodara</city>
        <state>Gujrat</state>
        <zip>390015</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>400012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nagpur</city>
        <state>Maharashtra</state>
        <zip>440010</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422 005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411 011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ludhiana</city>
        <state>Punjab</state>
        <zip>141002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bikaner</city>
        <state>Rajasthan</state>
        <zip>334003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500 063</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Indore</city>
        <zip>452014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ashkelon</city>
        <zip>78278</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Haifa</city>
        <zip>3436212</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Haifa</city>
        <zip>3525408</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rehovot</city>
        <zip>76100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Safed</city>
        <zip>13100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aosta</city>
        <state>AO</state>
        <zip>11100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cortona</city>
        <state>AR</state>
        <zip>52044</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bergamo</city>
        <state>BG</state>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Treviglio</city>
        <state>BG</state>
        <zip>24047</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cosenza</city>
        <state>CS</state>
        <zip>87100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cona</city>
        <state>FE</state>
        <zip>44100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Genova</city>
        <state>GE</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pozzilli</city>
        <state>IS</state>
        <zip>86077</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lido di Camaiore</city>
        <state>LU</state>
        <zip>55041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Milazzo</city>
        <state>ME</state>
        <zip>98057</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pisa</city>
        <state>PI</state>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pescia</city>
        <state>Point</state>
        <zip>51017</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pavia</city>
        <state>PV</state>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ariccia</city>
        <state>RM</state>
        <zip>00041</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00163</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Salerno</city>
        <state>SA</state>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sassari</city>
        <state>SS</state>
        <zip>07100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Wonju</city>
        <state>Gangwon-Do</state>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggi-do</state>
        <zip>16499</zip>
        <country>Korea, Republic of</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Korea</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Seocho-gu</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Daegu</city>
        <zip>705 718</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Daegu</city>
        <zip>705703</zip>
        <country>Korea, Republic of</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>05355</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-707</zip>
        <country>Korea, Republic of</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5417</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ventspils</city>
        <zip>LV-3601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-49387</zip>
        <country>Lithuania</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kedainiai</city>
        <zip>LT-57164</zip>
        <country>Lithuania</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50400</zip>
        <country>Malaysia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Juan del Rio</city>
        <state>Queretaro</state>
        <zip>76800</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aguascalientes</city>
        <zip>20230</zip>
        <country>Mexico</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78200</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Luis Potosí</city>
        <zip>78200</zip>
        <country>Mexico</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Breda</city>
        <state>CK</state>
        <zip>4818</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Amersfoort</city>
        <zip>3813 TZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Arnhem</city>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Blaricum</city>
        <zip>1261 AN</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Delft</city>
        <zip>2625 AD</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Den Bosch</city>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ede</city>
        <zip>6716 RP</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gorinchem</city>
        <zip>4204 AA</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hardenberg</city>
        <zip>7770 AA</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Harderwijk</city>
        <zip>3840 AC</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Heerenveen</city>
        <zip>8441 PW</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hengelo</city>
        <zip>7555 DL</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sneek</city>
        <zip>8601 ZK</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tilburg</city>
        <zip>5022 GC</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Veldhoven</city>
        <zip>5504 DB</zip>
        <country>Netherlands</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Panama City</city>
        <zip>0816-02351</zip>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bellavista</city>
        <state>Lima</state>
        <zip>CALLAO 02</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jesus Maria</city>
        <state>Lima</state>
        <zip>11</zip>
        <country>Peru</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>La Molina</city>
        <state>Lima</state>
        <zip>12</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Borja</city>
        <state>Lima</state>
        <zip>41</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Isidro</city>
        <state>Lima</state>
        <zip>27</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Miguel</city>
        <state>Lima</state>
        <zip>32</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Arequipa</city>
        <zip>AREQ01</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lipa City</city>
        <state>Batangas</state>
        <zip>4217</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Quezon City</city>
        <state>Manila</state>
        <zip>1100</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pasig City</city>
        <zip>1605</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1100</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1102</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gdynia</city>
        <zip>81-472</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gdynia</city>
        <zip>81-548</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-857</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vila Real</city>
        <state>Portuigal</state>
        <zip>5000-508</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Covilha</city>
        <zip>6200-251</zip>
        <country>Portugal</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guimaraes</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1449-005</zip>
        <country>Portugal</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Portalegre</city>
        <zip>7300-853</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Setubal</city>
        <zip>2910-446</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucharest</city>
        <state>District 1</state>
        <country>Romania</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucuresti</city>
        <state>District 1</state>
        <zip>014461</zip>
        <country>Romania</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Craiova</city>
        <state>Jud. Dolj</state>
        <zip>200497</zip>
        <country>Romania</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Timisoara</city>
        <state>Timis</state>
        <zip>300362</zip>
        <country>Romania</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucharest</city>
        <zip>050098</zip>
        <country>Romania</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bucuresti</city>
        <zip>011728</zip>
        <country>Romania</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Craiova</city>
        <zip>200642</zip>
        <country>Romania</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Deva</city>
        <zip>330084</zip>
        <country>Romania</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Timisoara</city>
        <zip>300041</zip>
        <country>Romania</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Timisoara</city>
        <zip>300736</zip>
        <country>Romania</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620137</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ivanovo</city>
        <zip>153012</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kazan</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kirov</city>
        <zip>610027</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Krasnodar</city>
        <zip>350012</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>101990</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>115280</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>115516</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>117198</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>119881</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>121309</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>121552</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>127473</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>N. Novgorod</city>
        <zip>603003</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>N.Novgorod</city>
        <zip>603005</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nizhnii Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Novosibirsk-117</city>
        <zip>630117</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Orenburg</city>
        <zip>460000</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Orenburg</city>
        <zip>460040</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Perm</city>
        <zip>614097</zip>
        <country>Russian Federation</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344022</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>S-Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>199106</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>191144</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194044</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saratov</city>
        <zip>410012</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Smolensk</city>
        <zip>214018</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St-Petersburg</city>
        <zip>194017</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St-Petersburg</city>
        <zip>194295</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St-Petersburg</city>
        <zip>196084</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vladimir</city>
        <zip>600020</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>169609</zip>
        <country>Singapore</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brezno</city>
        <state>Slovak Republic</state>
        <zip>977 42</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kosice</city>
        <state>Slovak Republic</state>
        <zip>040 22</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Levice</city>
        <state>Slovak Republic</state>
        <zip>93401</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Presov</city>
        <state>Slovak Republic</state>
        <zip>08001</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Svidnik</city>
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        <zip>08901</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>821 07</zip>
        <country>Slovakia</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>842 31</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>851 07</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>040 01</zip>
        <country>Slovakia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lucenec</city>
        <zip>984 01</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Martin</city>
        <zip>036 01</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bloemfontein</city>
        <state>Free State</state>
        <zip>9301</zip>
        <country>South Africa</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Soweto</city>
        <state>Gauteng</state>
        <zip>2013</zip>
        <country>South Africa</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Durban</city>
        <state>Kwa-Zulu Natal</state>
        <zip>4052</zip>
        <country>South Africa</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cape Town</city>
        <state>Western Cape</state>
        <zip>7405</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Alberton</city>
        <zip>1449</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bloemfontein</city>
        <zip>9301</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7405</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7505</zip>
        <country>South Africa</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Durban</city>
        <zip>4110</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Johannesburg</city>
        <zip>2193</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kempton Park</city>
        <zip>1620</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pretoria</city>
        <zip>0121</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pretoria</city>
        <zip>0184</zip>
        <country>South Africa</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Worcester</city>
        <zip>6850</zip>
        <country>South Africa</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Malaga</city>
        <state>Andalucia</state>
        <zip>29010</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marbella</city>
        <state>Andalucia</state>
        <zip>29600</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41014</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sant Joan Despi</city>
        <state>Cataluna</state>
        <zip>08970</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08003</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08035</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46010</zip>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46015</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>A Coruna</city>
        <state>Galicia</state>
        <zip>15006</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>La Coruna</city>
        <state>Galicia</state>
        <zip>15006</zip>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <city>Santiago de Compostela</city>
        <state>Galicia</state>
        <zip>15706</zip>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Vigo</city>
        <state>Galicia</state>
        <zip>36211</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28805</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mostoles</city>
        <state>Madrid</state>
        <zip>28935</zip>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stockholm</city>
        <state>SE</state>
        <zip>141 86</zip>
        <country>Sweden</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Goteborg</city>
        <zip>416 85</zip>
        <country>Sweden</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Göteborg</city>
        <zip>416 85</zip>
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  <location>
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      <address>
        <city>Karlshamn</city>
        <zip>37480</zip>
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  <location>
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        <zip>59185</zip>
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  <location>
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        <zip>50006</zip>
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  <location>
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  <location>
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  <location>
    <facility>
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      <address>
        <city>Taipei</city>
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  <location>
    <facility>
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      <address>
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  <location>
    <facility>
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  <location>
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  <location>
    <facility>
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      <address>
        <city>Taladkwan</city>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Khon Kaen</city>
        <state>THA</state>
        <zip>40002</zip>
        <country>Thailand</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muang</city>
        <zip>12120</zip>
        <country>Thailand</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34304</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kocaeli</city>
        <zip>41380</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sivas</city>
        <zip>58140</zip>
        <country>Turkey</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Durham</city>
        <state>County Durham</state>
        <zip>DH1 5TW</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dorchester</city>
        <state>Dorset</state>
        <zip>DT1 2JY</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Basingstoke</city>
        <state>Hampshire</state>
        <zip>RG24 9NA</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Portsmouth</city>
        <state>Hampshire</state>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Inverness</city>
        <state>Invernesshire</state>
        <zip>IV2 3RE</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oldham</city>
        <state>Lancashire</state>
        <zip>OL1 2JH</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE2 7LX</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Craigavon</city>
        <state>Northern Ireland</state>
        <zip>BT63 5QQ</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dundee</city>
        <state>Perthshire</state>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Taunton</city>
        <state>Somerset</state>
        <zip>TA1 5DA</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Yeovil</city>
        <state>Somerset</state>
        <zip>BA21 4AT</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Redhill</city>
        <state>Surrey</state>
        <zip>RH1 5RH</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>South Shields</city>
        <state>Tyne And Wear</state>
        <zip>NE34 0PL</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sunderland</city>
        <state>Tyne And Wear</state>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Dudley</city>
        <state>West Midlands</state>
        <zip>DY1 2HQ</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cheshire</city>
        <zip>CW1 4QJ</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5AX</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kent</city>
        <zip>DA2 8DA</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Milton Keynes</city>
        <zip>MK6 5LD</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Newport</city>
        <zip>NP20 2UB</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Newport</city>
        <zip>P030 5TG</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Poole</city>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Rotherham</city>
        <zip>S60 2OD</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Worcester</city>
        <zip>WR5 1DD</zip>
        <country>United Kingdom</country>
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  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Estonia</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Guatemala</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Malaysia</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Panama</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>China</country>
    <country>Colombia</country>
    <country>Czech Republic</country>
    <country>Dominican Republic</country>
    <country>Ecuador</country>
    <country>Iceland</country>
    <country>Venezuela</country>
  </removed_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>December 18, 2018</results_first_submitted>
  <results_first_submitted_qc>February 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 20, 2019</results_first_posted>
  <last_update_submitted>February 19, 2019</last_update_submitted>
  <last_update_submitted_qc>February 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LCZ696</keyword>
  <keyword>chronic heart failure</keyword>
  <keyword>ARNI</keyword>
  <keyword>Congestive heart failure (CHF)</keyword>
  <keyword>heart failure (HF)</keyword>
  <keyword>acute heart failure syndrome</keyword>
  <keyword>congestive cardiac failure (CCF)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sacubitril and valsartan sodium hydrate drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT02226120/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 28, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/20/NCT02226120/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 417 sites in 41 countries worldwide.</recruitment_details>
      <pre_assignment_details>The total number in the participant flow and baseline characteristics sections reflects the number of participants treated (1980).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>LCZ696</title>
          <description>Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1980"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1660"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="320"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Technical problems</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by parent/guardian</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>missing treatment disposition pages</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LCZ696</title>
          <description>Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1980"/>
          </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="67.2" spread="10.56"/>
                  </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="453"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1527"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="305"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1450"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696</title>
        <description>The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.</description>
        <time_frame>From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.</time_frame>
        <population>Safety Set (SAF), which consisted of all enrolled participants who received at least one dose of open-label study medication, was considered. Only descriptive analysis done.</population>
        <group_list>
          <group group_id="O1">
            <title>LCZ696</title>
            <description>Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696</title>
          <description>The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.</description>
          <population>Safety Set (SAF), which consisted of all enrolled participants who received at least one dose of open-label study medication, was considered. Only descriptive analysis done.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1980"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs by Primary System Organ Class (SOC)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs by Primary System Organ Class (SOC)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths by Primary System Organ Class (SOC)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study treatment to 30 days after last dose of study treatment, approximately 30 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>LCZ696</title>
          <description>Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</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="186" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="555" subjects_at_risk="1980"/>
              </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="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Normocytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Adams-Stokes syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="144" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiorenal syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiovascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Congestive cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cor pulmonale</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Nodal rhythm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Systolic dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Phimosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </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="2" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Open angle glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Refraction disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Gastrointestinal angiodysplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Intestinal pseudo-obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Mesenteric vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pancreatic mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hepatic congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bursitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Campylobacter gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diabetic foot infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ecthyma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hepatitis E</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hepatitis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Intervertebral discitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ovarian abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pneumococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Sepsis syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Stoma site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Tracheobronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Viral diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Wound sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Chest injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Electric shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Fractured skull depressed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Incisional hernia, obstructive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Respiratory fume inhalation disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Subdural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Vascular graft occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Arteriogram coronary</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ejection fraction abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Functional residual capacity decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diabetic complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Rheumatic disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bladder cancer recurrent</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bladder neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bone cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bone cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Laryngeal cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Oesophageal squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Brain injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cerebral ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Cervicogenic vertigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hemianaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hypoxic-ischaemic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Post stroke seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device battery issue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Device malfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Lead dislodgement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </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="18" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Acquired hydrocele</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Acquired phimosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Genital ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Asphyxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bronchial oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bronchitis chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Treatment noncompliance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Aortic embolus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Diabetic vascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Leriche syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Peripheral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="352" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="118" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="252" subjects_at_risk="1980"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Two patients had missing treatment epoch disposition pages but were included in Safety Analysis Set (SAF)</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
      <email>Novartis.email@novartis.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/NCT02226120
org study id: CLCZ696B2317
secondary id: 2014-001971-30
nct id: NCT02226120
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to collect safety and tolerability data on LCZ696 in eligible
      PARADIGM-HF patients who received open-label investigational drug. The parent PARADIGM-HF
      (NCT01035255) trial was terminated early due to compelling efficacy of LCZ696 in patients
      with heart failure with reduced ejection fraction (HFrEF) after the final pre-specified
      interim analysis in March 2014.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths as a Measure of Safety and Tolerability of LCZ696
time frame: From first dose of study treatment to 30 days after last dose of study treatment, up to 30 months.
description: The primary assessments for safety were the reporting of angioedema, AEs suspected to be related to LCZ696, AEs leading to study drug discontinuation and serious adverse events (SAE) including death. The assessment of safety were based primarily on the frequency of adverse events of special interest, sitting systolic and diastolic blood pressure, heart rate, and serious adverse events suspected by the investigators to be related to LCZ696 for the Safety set. Only descriptive analysis done.
arm group label: LCZ696
arm group type: Experimental
description: Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
intervention type: Drug
intervention name: LCZ696
description: Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
arm group label: LCZ696
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Argentina
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: Czechia
country: Denmark
country: Estonia
country: Finland
country: France
country: Germany
country: Guatemala
country: Hong Kong
country: Hungary
country: India
country: Israel
country: Italy
country: Korea, Republic of
country: Latvia
country: Lithuania
country: Malaysia
country: Mexico
country: Netherlands
country: Panama
country: Peru
country: Philippines
country: Poland
country: Portugal
country: Romania
country: Russian Federation
country: Singapore
country: Slovakia
country: South Africa
country: Spain
country: Sweden
country: Taiwan
country: Thailand
country: Turkey
country: United Kingdom
country: United States
country: China
country: Colombia
country: Czech Republic
country: Dominican Republic
country: Ecuador
country: Iceland
country: Venezuela
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Sacubitril and valsartan sodium hydrate drug combination
sharing ipd: Undecided
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Two patients had missing treatment epoch disposition pages but were included in Safety Analysis Set (SAF)
point of contact: 