<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/NCT02992288</url>
  </required_header>
  <id_info>
    <org_study_id>15128</org_study_id>
    <secondary_id>2016-003839-38</secondary_id>
    <nct_id>NCT02992288</nct_id>
  </id_info>
  <brief_title>A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction</brief_title>
  <acronym>PANTHEON</acronym>
  <official_title>A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double Blind, Dose-finding Phase II Trial to Study the Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of the Oral Partial Adenosine A1 Receptor Agonist Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Reduced Ejection Fraction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>Yes</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 objective of the study is to find the optimal dose of once daily oral neladenoson&#xD;
      bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with&#xD;
      reduced ejection fraction (HFrEF).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">May 16, 2018</completion_date>
  <primary_completion_date type="Actual">March 28, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography</measure>
    <time_frame>Baseline, Week 20</time_frame>
    <description>Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20</measure>
    <time_frame>Baseline, Week 20</time_frame>
    <description>NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20</measure>
    <time_frame>Baseline, Week 20</time_frame>
    <description>LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20</measure>
    <time_frame>Baseline, Week 20</time_frame>
    <description>LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20</measure>
    <time_frame>Baseline, Week 20</time_frame>
    <description>High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite Efficacy Outcome</measure>
    <time_frame>Baseline up to Week 26</time_frame>
    <description>Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Cardiovascular (CV) Mortality</measure>
    <time_frame>Baseline up to Week 26</time_frame>
    <description>Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)</measure>
    <time_frame>Baseline up to Week 26</time_frame>
    <description>Number of participants with HF hospitalization and urgent visits for HF were reported.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">427</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (5 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic heart failure with reduced ejection fraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (10 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic heart failure with reduced ejection fraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (20 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic heart failure with reduced ejection fraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (30 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic heart failure with reduced ejection fraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (40 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chronic heart failure with reduced ejection fraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Chronic heart failure with reduced ejection fraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neladenoson bialanate (BAY1067197)</intervention_name>
    <description>5 mg orally once daily for 20 weeks</description>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (5 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neladenoson bialanate (BAY1067197)</intervention_name>
    <description>10 mg orally once daily for 20 weeks</description>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (10 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neladenoson bialanate (BAY1067197)</intervention_name>
    <description>20 mg orally once daily for 20 weeks</description>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (20 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neladenoson bialanate (BAY1067197)</intervention_name>
    <description>30 mg orally once daily for 20 weeks</description>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (30 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neladenoson bialanate (BAY1067197)</intervention_name>
    <description>40 mg orally once daily for 20 weeks</description>
    <arm_group_label>Neladenoson bialanate (BAY1067197) (40 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Orally once daily for 20 weeks</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women aged 18 years and older&#xD;
&#xD;
          -  Diagnosis of chronic heart failure (CHF), NYHA ( New York Heart Association ) class&#xD;
             II-IV, LVEF ≤ 35% and elevated NT-proBNP&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute de-novo heart failure&#xD;
&#xD;
          -  Requirement of any intravenous (IV) treatments following 48 hours prior to&#xD;
             randomization&#xD;
&#xD;
          -  Mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation,&#xD;
             mechanical ventilation, or any ventricular assist device)&#xD;
&#xD;
          -  Any cause of chronic heart failure other than ischemic cardiomyopathy and idiopathic&#xD;
             dilated cardiomyopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southwest Florida Research</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Heart &amp; Vascular, PC</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glacier View Research Institute-Cardiology</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Medical Center</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Youngstown Hospital</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Center for Clinical Trials</name>
      <address>
        <city>Tullahoma</city>
        <state>Tennessee</state>
        <zip>37388</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Texas Cardiology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ St-Jan Brugge Oostende AV</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hôpital de Charleroi</name>
      <address>
        <city>Gilly</city>
        <zip>6060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Delta</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Turnhout</name>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik</name>
      <address>
        <city>Pernik</city>
        <zip>2300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Specialized Hospital for Actrive Treatm of Card - Pleven</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NMTH Tzar Boris III</name>
      <address>
        <city>Sofia</city>
        <zip>1233</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Tsaritsa Joanna-ISUL EAD Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Sveta Sofia</name>
      <address>
        <city>Sofia</city>
        <zip>1618</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Dr Stefan Cherkezov</name>
      <address>
        <city>Veliko Tarnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover (MHH)</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)</name>
      <address>
        <city>Bad Oeynhausen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.-Johannes-Hospital Dortmund</name>
      <address>
        <city>Dortmund</city>
        <state>Nordrhein-Westfalen</state>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Maria Hilf GmbH</name>
      <address>
        <city>Mönchengladbach</city>
        <state>Nordrhein-Westfalen</state>
        <zip>41063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Stadt Ludwigshafen am Rhein gGmbH</name>
      <address>
        <city>Ludwigshafen</city>
        <state>Rheinland-Pfalz</state>
        <zip>67063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Campus Virchow-Klinikum (CVK)</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KAT General Hospital of Athens</name>
      <address>
        <city>Kifisia / Athens</city>
        <state>Attica</state>
        <zip>14561</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>G. Gennimatas General State Hospital of Athens</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thriassio General Hospital of Elefsina</name>
      <address>
        <city>Elefsina</city>
        <zip>19018</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konstantopoulio General Hospital of Nea Ionia - Agia Olga</name>
      <address>
        <city>Nea Ionia / Athens</city>
        <zip>142 33</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hippokration General Hospital of Thessaloniki</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54642</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barzilai Medical Center</name>
      <address>
        <city>Ashkelon</city>
        <zip>7830604</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>3810101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Corporation</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103102</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah University Hospital Mount Scopus</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Assaf Harofeh Medical Center</name>
      <address>
        <city>Zrifin</city>
        <zip>6093000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico Federico II Napoli</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <state>Lombardia</state>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <state>Lombardia</state>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Centro Cardiologico Fondazione Monzino</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AUSL 8 Arezzo</name>
      <address>
        <city>Arezzo</city>
        <state>Toscana</state>
        <zip>52040</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital</name>
      <address>
        <city>Maebashi</city>
        <state>Gunma</state>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Takasaki General Medical C</name>
      <address>
        <city>Takasaki</city>
        <state>Gunma</state>
        <zip>370-0829</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Prefectural Amagasaki General Medical Center</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <zip>660-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National hospital Organization Mito Medical Center</name>
      <address>
        <city>Higashiibaraki</city>
        <state>Ibaraki</state>
        <zip>311-3193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R.I.A.C Naha City Hospital</name>
      <address>
        <city>Naha</city>
        <state>Okinawa</state>
        <zip>902-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kishiwada Tokushukai Hospital</name>
      <address>
        <city>Kishiwada</city>
        <state>Osaka</state>
        <zip>596-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Takatsuki Red Cross Hospital</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <zip>569-1096</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minamino Cardiovascular Hospital</name>
      <address>
        <city>Hachioji</city>
        <state>Tokyo</state>
        <zip>192-0918</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon University Itabashi Hospital</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo</state>
        <zip>173-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama Rosai Hospital</name>
      <address>
        <city>Okayama</city>
        <zip>702-8055</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka General Medical Center</name>
      <address>
        <city>Osaka</city>
        <zip>558-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toyama Prefectural Central Hospital</name>
      <address>
        <city>Toyama</city>
        <zip>930-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1091 AC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Rijnstate</name>
      <address>
        <city>Arnhem</city>
        <zip>6815 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700 RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KLIMED Marek Klimkiewicz</name>
      <address>
        <city>Bialystok</city>
        <zip>15-776</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CLINICAL MEDICAL RESEARCH Sp. z o. o.</name>
      <address>
        <city>Katowice</city>
        <zip>40-156</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny im. J. Dietla</name>
      <address>
        <city>Krakow</city>
        <zip>31-121</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nzoz Salus</name>
      <address>
        <city>Lodz</city>
        <zip>91-302</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny Przemienienia Panskiego</name>
      <address>
        <city>Poznan</city>
        <zip>61-848</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twoja Przychodnia - Szczecinskie Centrum Medyczne</name>
      <address>
        <city>Szczecin</city>
        <zip>71-434</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-981</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>A Coruña</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario &quot;Virgen de la Arrixaca&quot;</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.clinicaltrialsregister.eu/</url>
    <description>Click here to find information about studies related to Bayer Healthcare products conducted in Europe.</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>March 11, 2019</results_first_submitted>
  <results_first_submitted_qc>April 19, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 23, 2019</results_first_posted>
  <last_update_submitted>April 19, 2019</last_update_submitted>
  <last_update_submitted_qc>April 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Heart Failure</keyword>
  <keyword>Heart Failure with Reduced Ejection Fraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <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>May 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT02992288/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>February 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT02992288/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted at multiple centers in 11 countries between 22 February 2017 (first participant first visit) and 16 May 2018 (last participant last visit).</recruitment_details>
      <pre_assignment_details>Overall, 462 participants were screened. Of them, 35 participants did not complete screening due to unmet eligibility criteria, consent withdrawal, adverse events and other unspecified reasons. In total, 427 participants were randomized and 426 participants received study treatment.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Neladenoson Bialanate 5 mg</title>
          <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Neladenoson Bialanate 10 mg</title>
          <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Neladenoson Bialanate 20 mg</title>
          <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="P5">
          <title>Neladenoson Bialanate 30 mg</title>
          <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="P6">
          <title>Neladenoson Bialanate 40 mg</title>
          <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="70"/>
                <participants group_id="P4" count="73"/>
                <participants group_id="P5" count="69"/>
                <participants group_id="P6" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="70"/>
                <participants group_id="P4" count="72"/>
                <participants group_id="P5" count="69"/>
                <participants group_id="P6" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="63"/>
                <participants group_id="P4" count="64"/>
                <participants group_id="P5" count="61"/>
                <participants group_id="P6" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set (FAS) included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Neladenoson Bialanate 5 mg</title>
          <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Neladenoson Bialanate 10 mg</title>
          <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Neladenoson Bialanate 20 mg</title>
          <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Neladenoson Bialanate 30 mg</title>
          <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="B6">
          <title>Neladenoson Bialanate 40 mg</title>
          <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="106"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="70"/>
            <count group_id="B4" value="73"/>
            <count group_id="B5" value="69"/>
            <count group_id="B6" value="72"/>
            <count group_id="B7" value="427"/>
          </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="66.9" spread="9.4"/>
                    <measurement group_id="B2" value="66.6" spread="10.5"/>
                    <measurement group_id="B3" value="66.4" spread="11.2"/>
                    <measurement group_id="B4" value="68.1" spread="10.0"/>
                    <measurement group_id="B5" value="67.6" spread="9.8"/>
                    <measurement group_id="B6" value="67.5" spread="10.0"/>
                    <measurement group_id="B7" value="67.2" spread="10.0"/>
                  </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="18"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="57"/>
                    <measurement group_id="B6" value="65"/>
                    <measurement group_id="B7" value="356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="69"/>
                    <measurement group_id="B4" value="72"/>
                    <measurement group_id="B5" value="66"/>
                    <measurement group_id="B6" value="72"/>
                    <measurement group_id="B7" value="421"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="65"/>
                    <measurement group_id="B4" value="66"/>
                    <measurement group_id="B5" value="64"/>
                    <measurement group_id="B6" value="65"/>
                    <measurement group_id="B7" value="390"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left ventricular ejection fraction (LVEF)</title>
          <description>Left ventricular ejection fraction (LVEF) is defined as the fraction of blood being pumped out of the left ventricle of the heart with each contraction.</description>
          <units>Percentage of LVEF</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.24" spread="10.67"/>
                    <measurement group_id="B2" value="26.22" spread="7.99"/>
                    <measurement group_id="B3" value="27.58" spread="8.92"/>
                    <measurement group_id="B4" value="29.70" spread="10.87"/>
                    <measurement group_id="B5" value="29.87" spread="11.54"/>
                    <measurement group_id="B6" value="26.24" spread="8.92"/>
                    <measurement group_id="B7" value="28.18" spread="10.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Class</title>
          <description>NYHA classifies the extent of heart failure as Class I: Cardiac disease without resulting limitation of physical activity, Class II: Cardiac disease resulting in slight limitation of physical activity, Class III: Cardiac disease resulting in marked limitation of physical activity and Class IV: Cardiac disease resulting in inability to carry out any physical activity without discomfort.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Class I</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="44"/>
                    <measurement group_id="B5" value="49"/>
                    <measurement group_id="B6" value="49"/>
                    <measurement group_id="B7" value="265"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class III/IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>N-terminal pro-hormone b-type natriuretic peptide (NT-proBNP)</title>
          <units>Picograms per milliliter (pg/mL)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2111.00" lower_limit="78.0" upper_limit="30428.0"/>
                    <measurement group_id="B2" value="2071.00" lower_limit="155.0" upper_limit="17760.0"/>
                    <measurement group_id="B3" value="2063.00" lower_limit="25.5" upper_limit="49896.0"/>
                    <measurement group_id="B4" value="1894.50" lower_limit="56.0" upper_limit="13294.0"/>
                    <measurement group_id="B5" value="2084.00" lower_limit="406.0" upper_limit="24551.0"/>
                    <measurement group_id="B6" value="2419.00" lower_limit="60.0" upper_limit="13387.0"/>
                    <measurement group_id="B7" value="2085.00" lower_limit="25.5" upper_limit="49896.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical history: Chronic heart failure etiology</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Ischemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="50"/>
                    <measurement group_id="B5" value="37"/>
                    <measurement group_id="B6" value="42"/>
                    <measurement group_id="B7" value="264"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-ischemic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="32"/>
                    <measurement group_id="B6" value="30"/>
                    <measurement group_id="B7" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical history: Atrial fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>With Atrial fibrillation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="27"/>
                    <measurement group_id="B6" value="33"/>
                    <measurement group_id="B7" value="171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Without Atrial fibrillation</title>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="47"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="39"/>
                    <measurement group_id="B7" value="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication of interest: Beta-blocker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Beta-blocker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="66"/>
                    <measurement group_id="B4" value="70"/>
                    <measurement group_id="B5" value="67"/>
                    <measurement group_id="B6" value="69"/>
                    <measurement group_id="B7" value="412"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not used at baseline</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication of interest: Angiotensin-converting enzyme inhibitor</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Angiotensin-converting enzyme inhibitor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="36"/>
                    <measurement group_id="B6" value="45"/>
                    <measurement group_id="B7" value="240"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not used at baseline</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="29"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="33"/>
                    <measurement group_id="B6" value="27"/>
                    <measurement group_id="B7" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication of interest: Angiotensin receptor blocker</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Angiotensin receptor blocker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not used at baseline</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="59"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="60"/>
                    <measurement group_id="B6" value="63"/>
                    <measurement group_id="B7" value="363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication of interest: Angiotensin receptor-neprilysin inhibitor</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Angiotensin receptor-neprilysin inhibitor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not used at baseline</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="64"/>
                    <measurement group_id="B5" value="57"/>
                    <measurement group_id="B6" value="60"/>
                    <measurement group_id="B7" value="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medication of interest: Mineralocorticoid receptor antagonist</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Mineralocorticoid receptor antagonist</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="60"/>
                    <measurement group_id="B5" value="56"/>
                    <measurement group_id="B6" value="57"/>
                    <measurement group_id="B7" value="355"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not used at baseline</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography</title>
        <description>Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.</description>
        <time_frame>Baseline, Week 20</time_frame>
        <population>Per-protocol set (PPS) included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to cardiovascular (CV) death or heart failure (HF) hospitalization or with other major protocol deviation were excluded from PPS LVEF set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography</title>
          <description>Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.</description>
          <population>Per-protocol set (PPS) included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to cardiovascular (CV) death or heart failure (HF) hospitalization or with other major protocol deviation were excluded from PPS LVEF set.</population>
          <units>Percentage of LVEF</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.19" spread="8.39"/>
                    <measurement group_id="O2" value="2.59" spread="8.48"/>
                    <measurement group_id="O3" value="-3.01" spread="10.43"/>
                    <measurement group_id="O4" value="0.13" spread="8.74"/>
                    <measurement group_id="O5" value="-2.45" spread="10.54"/>
                    <measurement group_id="O6" value="1.53" spread="10.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2297</p_value>
            <p_value_desc>Linear dose-response shape: The multiple comparison procedures (MCP) approach was applied to calculate the adjusted one-sided one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4409</p_value>
            <p_value_desc>Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2842</p_value>
            <p_value_desc>Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2534</p_value>
            <p_value_desc>Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3842</p_value>
            <p_value_desc>Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20</title>
        <description>NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.</description>
        <time_frame>Baseline, Week 20</time_frame>
        <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20</title>
          <description>NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.</description>
          <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</population>
          <units>log picograms per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="53"/>
                <count group_id="O6" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.70"/>
                    <measurement group_id="O2" value="-0.24" spread="0.90"/>
                    <measurement group_id="O3" value="-0.07" spread="0.52"/>
                    <measurement group_id="O4" value="-0.07" spread="0.56"/>
                    <measurement group_id="O5" value="0.07" spread="0.55"/>
                    <measurement group_id="O6" value="-0.08" spread="0.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8966</p_value>
            <p_value_desc>Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9233</p_value>
            <p_value_desc>Sigmoidal Emax 1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9296</p_value>
            <p_value_desc>Sigmoidal Emax 2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7357</p_value>
            <p_value_desc>Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9083</p_value>
            <p_value_desc>Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20</title>
        <description>LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.</description>
        <time_frame>Baseline, Week 20</time_frame>
        <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20</title>
          <description>LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.</description>
          <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.</population>
          <units>Milliliters (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.44" spread="33.29"/>
                    <measurement group_id="O2" value="-21.41" spread="48.13"/>
                    <measurement group_id="O3" value="-2.82" spread="35.12"/>
                    <measurement group_id="O4" value="-4.32" spread="29.73"/>
                    <measurement group_id="O5" value="-3.12" spread="33.96"/>
                    <measurement group_id="O6" value="-15.16" spread="39.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4596</p_value>
            <p_value_desc>Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7859</p_value>
            <p_value_desc>Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5562</p_value>
            <p_value_desc>Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5338</p_value>
            <p_value_desc>Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7303</p_value>
            <p_value_desc>Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20</title>
        <description>LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.</description>
        <time_frame>Baseline, Week 20</time_frame>
        <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20</title>
          <description>LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.</description>
          <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline LVEF values not due to CV death or HF hospitalization or with other major protocol deviation were excluded from PPS LVEF set.</population>
          <units>Milliliters (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="47"/>
                <count group_id="O5" value="40"/>
                <count group_id="O6" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.16" spread="40.23"/>
                    <measurement group_id="O2" value="-21.65" spread="61.96"/>
                    <measurement group_id="O3" value="-12.44" spread="39.84"/>
                    <measurement group_id="O4" value="-5.92" spread="30.89"/>
                    <measurement group_id="O5" value="-11.17" spread="42.32"/>
                    <measurement group_id="O6" value="-19.69" spread="48.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5703</p_value>
            <p_value_desc>Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8253</p_value>
            <p_value_desc>Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6506</p_value>
            <p_value_desc>Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6923</p_value>
            <p_value_desc>Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.8036</p_value>
            <p_value_desc>Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20</title>
        <description>High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.</description>
        <time_frame>Baseline, Week 20</time_frame>
        <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20</title>
          <description>High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.</description>
          <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</population>
          <units>Picograms per milliliter (pg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="53"/>
                <count group_id="O6" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="9.98"/>
                    <measurement group_id="O2" value="6.46" spread="33.04"/>
                    <measurement group_id="O3" value="3.77" spread="22.32"/>
                    <measurement group_id="O4" value="7.43" spread="37.79"/>
                    <measurement group_id="O5" value="2.59" spread="12.90"/>
                    <measurement group_id="O6" value="7.03" spread="24.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9955</p_value>
            <p_value_desc>Linear dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9946</p_value>
            <p_value_desc>Sigmoidal Emax1 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9913</p_value>
            <p_value_desc>Sigmoidal Emax2 dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9982</p_value>
            <p_value_desc>Emax dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9959</p_value>
            <p_value_desc>Quadratic dose-response shape: The MCP approach was applied to calculate the adjusted one-sided p-values of the contrast test.</p_value_desc>
            <method>MCP-Mod method</method>
            <method_desc>Dose response relationship was assessed using the MCP-Mod method combining MCP principles with modeling techniques under model uncertainty.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite Efficacy Outcome</title>
        <description>Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.</description>
        <time_frame>Baseline up to Week 26</time_frame>
        <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite Efficacy Outcome</title>
          <description>Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.</description>
          <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</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="82"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="53"/>
                <count group_id="O6" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Cardiovascular (CV) Mortality</title>
        <description>Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.</description>
        <time_frame>Baseline up to Week 26</time_frame>
        <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cardiovascular (CV) Mortality</title>
          <description>Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.</description>
          <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</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="82"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="53"/>
                <count group_id="O6" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)</title>
        <description>Number of participants with HF hospitalization and urgent visits for HF were reported.</description>
        <time_frame>Baseline up to Week 26</time_frame>
        <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Neladenoson Bialanate 5 mg</title>
            <description>Participants received 5 milligrams (mg) of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Neladenoson Bialanate 10 mg</title>
            <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Neladenoson Bialanate 20 mg</title>
            <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Neladenoson Bialanate 30 mg</title>
            <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Neladenoson Bialanate 40 mg</title>
            <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)</title>
          <description>Number of participants with HF hospitalization and urgent visits for HF were reported.</description>
          <population>PPS included all participants without validity findings affecting efficacy evaluation. The participants with invalid/missing baseline or missing post-baseline BNP value not due to CV death or HF hospitalization or with other major protocol deviation were excluded from the PPS BNP.</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="82"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="53"/>
                <count group_id="O6" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration up to 26 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo matched to neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Neladenoson Bialanate 5mg</title>
          <description>Participants received 5 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Neladenoson Bialanate 10mg</title>
          <description>Participants received 10 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Neladenoson Bialanate 20mg</title>
          <description>Participants received 20 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Neladenoson Bialanate 30mg</title>
          <description>Participants received 30 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
        <group group_id="E6">
          <title>Neladenoson Bialanate 40mg</title>
          <description>Participants received 40 mg of neladenoson bialanate tablets orally once daily for 20 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="70"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="28" subjects_at_risk="69"/>
                <counts group_id="E6" subjects_affected="26" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="106"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="37"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="70"/>
                <counts group_id="E4" events="10" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E5" events="17" subjects_affected="10" subjects_at_risk="69"/>
                <counts group_id="E6" events="16" subjects_affected="11" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="7" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Low cardiac output syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Oedema due to cardiac disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Serratia sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Traumatic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Arteriogram coronary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Device function test</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic lymphocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Renal cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Atrial septal defect repair</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac pacemaker insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac pacemaker replacement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Implantable defibrillator insertion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Ventricular assist device insertion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Implantable defibrillator replacement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Cardiac resynchronisation therapy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Colectomy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Peripheral ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="70"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="24" subjects_at_risk="69"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="69"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="106"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="69"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="69"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" events="8" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="69"/>
                <counts group_id="E6" events="7" subjects_affected="7" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="69"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 30 days but less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Therapeutic Area Head</name_or_title>
      <organization>Bayer</organization>
      <phone>1-888-8422937</phone>
      <email>clinical-trials-contact@bayer.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/NCT02992288
org study id: 15128
secondary id: 2016-003839-38
nct id: NCT02992288
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The objective of the study is to find the optimal dose of once daily oral neladenoson
      bialanate (BAY 1067197) when given in addition to standard therapy for heart failure with
      reduced ejection fraction (HFrEF).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) (%) at Week 20 Measured by Echocardiography
time frame: Baseline, Week 20
description: Left ventricular ejection fraction (LVEF) was measured by echocardiography. Mean and standard deviation were reported.
measure: Absolute Change From Baseline in Log-transformed NT-pro B-type Natriuretic Peptide (BNP) at Week 20
time frame: Baseline, Week 20
description: NT-pro b-type Natriuretic Peptide (BNP) was measured. Mean and standard deviation were reported.
measure: Change From Baseline in Left Ventricular End-Systolic Volume (LVESV) at Week 20
time frame: Baseline, Week 20
description: LVESV was defined as the volume of blood in the left ventricle at the end of contraction, or systole and the beginning of filling or diastole. Mean and standard deviation were reported.
measure: Change From Baseline in Left Ventricular End-Diastolic Volume (LVEDV) at Week 20
time frame: Baseline, Week 20
description: LVEDV was defined as the volume of blood in the left ventricle at end load or filling in diastole or the amount of blood in the ventricles just before systole. Mean and standard deviation were reported.
measure: Change From Baseline in High Sensitivity Troponin T (Hs-TNT) at Week 20
time frame: Baseline, Week 20
description: High sensitivity troponin T (hs-TNT) was measured. Mean and standard deviation were reported.
measure: Number of Participants With Composite Efficacy Outcome
time frame: Baseline up to Week 26
description: Composite efficacy outcome was the first occurrence of CV death, HF hospitalization or urgent visit for HF. Number of participants with composite efficacy outcome were reported.
measure: Number of Participants With Cardiovascular (CV) Mortality
time frame: Baseline up to Week 26
description: Cardiovascular (CV) mortality was assessed. Number of participants with CV mortality were reported.
measure: Number of Participants With Heart Failure (HF) Hospitalization and Urgent Visits for Heart Failure (HF)
time frame: Baseline up to Week 26
description: Number of participants with HF hospitalization and urgent visits for HF were reported.
arm group label: Neladenoson bialanate (BAY1067197) (5 mg)
arm group type: Experimental
description: Chronic heart failure with reduced ejection fraction
arm group label: Neladenoson bialanate (BAY1067197) (10 mg)
arm group type: Experimental
description: Chronic heart failure with reduced ejection fraction
arm group label: Neladenoson bialanate (BAY1067197) (20 mg)
arm group type: Experimental
description: Chronic heart failure with reduced ejection fraction
arm group label: Neladenoson bialanate (BAY1067197) (30 mg)
arm group type: Experimental
description: Chronic heart failure with reduced ejection fraction
arm group label: Neladenoson bialanate (BAY1067197) (40 mg)
arm group type: Experimental
description: Chronic heart failure with reduced ejection fraction
arm group label: Placebo
arm group type: Placebo Comparator
description: Chronic heart failure with reduced ejection fraction
intervention type: Drug
intervention name: Neladenoson bialanate (BAY1067197)
description: 5 mg orally once daily for 20 weeks
arm group label: Neladenoson bialanate (BAY1067197) (5 mg)
intervention type: Drug
intervention name: Neladenoson bialanate (BAY1067197)
description: 10 mg orally once daily for 20 weeks
arm group label: Neladenoson bialanate (BAY1067197) (10 mg)
intervention type: Drug
intervention name: Neladenoson bialanate (BAY1067197)
description: 20 mg orally once daily for 20 weeks
arm group label: Neladenoson bialanate (BAY1067197) (20 mg)
intervention type: Drug
intervention name: Neladenoson bialanate (BAY1067197)
description: 30 mg orally once daily for 20 weeks
arm group label: Neladenoson bialanate (BAY1067197) (30 mg)
intervention type: Drug
intervention name: Neladenoson bialanate (BAY1067197)
description: 40 mg orally once daily for 20 weeks
arm group label: Neladenoson bialanate (BAY1067197) (40 mg)
intervention type: Drug
intervention name: Placebo
description: Orally once daily for 20 weeks
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
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facility: 
facility: 
country: Belgium
country: Bulgaria
country: Germany
country: Greece
country: Israel
country: Italy
country: Japan
country: Netherlands
country: Poland
country: Spain
country: United States
url: http://www.clinicaltrialsregister.eu/
description: Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
responsible party type: Sponsor
mesh term: Heart Failure
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 