<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/NCT02194465</url>
  </required_header>
  <id_info>
    <org_study_id>15525</org_study_id>
    <secondary_id>I7T-MC-RMAH</secondary_id>
    <nct_id>NCT02194465</nct_id>
  </id_info>
  <brief_title>A Study of LY2623091 in Participants With High Blood Pressure</brief_title>
  <official_title>A Randomized, Placebo-Controlled, Double-Blinded, Parallel, Phase 2a Study to Evaluate the Safety and Efficacy of LY2623091 in Patients With Primary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate the safety and effectiveness of the study drug&#xD;
      known as LY2623091 in participants with high blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)</measure>
    <time_frame>Baseline, 4 Weeks</time_frame>
    <description>Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)</measure>
    <time_frame>Baseline, 4 Weeks</time_frame>
    <description>Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)</measure>
    <time_frame>Baseline, 4 Weeks</time_frame>
    <description>The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to 4 Weeks in Serum Potassium</measure>
    <time_frame>Baseline, 4 Weeks</time_frame>
    <description>Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment*visit and race.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091</measure>
    <time_frame>2 hours post-dose at 4 Weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">304</enrollment>
  <condition>Primary Hypertension</condition>
  <arm_group>
    <arm_group_label>6 milligrams (mg) LY2623091</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>13 mg LY2623091</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>24.5 mg LY2623091</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>13 mg LY2623091 + 20 mg tadalafil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 mg tadalafil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spironolactone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2623091</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>13 mg LY2623091</arm_group_label>
    <arm_group_label>13 mg LY2623091 + 20 mg tadalafil</arm_group_label>
    <arm_group_label>24.5 mg LY2623091</arm_group_label>
    <arm_group_label>6 milligrams (mg) LY2623091</arm_group_label>
    <other_name>Mineralocorticoid Receptor Antagonist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>13 mg LY2623091 + 20 mg tadalafil</arm_group_label>
    <arm_group_label>20 mg tadalafil</arm_group_label>
    <other_name>LY450190</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Spironolactone</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Spironolactone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>13 mg LY2623091</arm_group_label>
    <arm_group_label>13 mg LY2623091 + 20 mg tadalafil</arm_group_label>
    <arm_group_label>20 mg tadalafil</arm_group_label>
    <arm_group_label>24.5 mg LY2623091</arm_group_label>
    <arm_group_label>6 milligrams (mg) LY2623091</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a history of hypertension.&#xD;
&#xD;
          -  If participants are naïve to treatment of hypertension, or have not been treated with&#xD;
             any antihypertensive medications within the 30 days immediately prior to screening:&#xD;
&#xD;
               -  Have seated systolic (SBP) of ≥140 and &lt;170 millimeters of mercury (mmHg) at&#xD;
                  screening and at the end of the lead-in period.&#xD;
&#xD;
          -  If participants are currently being treated for hypertension:&#xD;
&#xD;
               -  Are taking a stable dose of 1 or 2 antihypertensive medications for at least the&#xD;
                  previous 30 days. A combination antihypertensive medication from 2 classes is&#xD;
                  considered as 2 antihypertensive medications.&#xD;
&#xD;
               -  Are willing to discontinue the antihypertensive medications during the study.&#xD;
&#xD;
               -  Have seated SBP of ≥140 and &lt;170 mmHg at the end of the lead-in period.&#xD;
&#xD;
          -  Have a body mass index (BMI) ≥18.5 and &lt;40 kilograms/m^2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP)&#xD;
             ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or&#xD;
             hospitalization due to hypertension.&#xD;
&#xD;
          -  Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or&#xD;
             randomization.&#xD;
&#xD;
          -  Have a history of hospitalization due to hyperkalemia, or history of drug&#xD;
             discontinuation due to elevated serum potassium levels.&#xD;
&#xD;
          -  Have a serum potassium ≤3.5 or &gt;5.0 millimoles per liter (mmol/L).&#xD;
&#xD;
          -  Have an estimated glomerular filtration rate (eGFR) &lt;50 milliliters/minute/1.73 m^2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Advantage</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Muir Health Network - The Osteoporosis Center</name>
      <address>
        <city>Concord</city>
        <state>California</state>
        <zip>94520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encompass Clinical Research</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alan Graff, MD, PA</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jacksonville Center for Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Center of Sarasota</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East West Medical Institute</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Diabetes and Osteoporosis Center</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Heart Clinical Research, LLC</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedar-Crosse Research Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Institute for Clinical Research</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Clinical Research Center</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grace Research</name>
      <address>
        <city>Bossier City</city>
        <state>Louisiana</state>
        <zip>71111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Research Associates</name>
      <address>
        <city>Auburn</city>
        <state>Maine</state>
        <zip>04210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AB Clinical Trials</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research, Inc.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metrolina Internal Medicine, P.A.</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PharmQuest</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lillestol Research LLC</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sterling Research Group, LTD</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid Medical Research Inc</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Clinical Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Clinical Research</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cor Clinical Research LLC</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>4052728481</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Foundation For Cardiovascular Research</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain View Clinical Research, Inc</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes and Endocrinology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731-4309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research, Inc</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Diabetes and Endocrinology, P.A.</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Clinical Research Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98007-4209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universal Research Group, LLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Brampton</city>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kelowna</city>
        <zip>V1Y3G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Peterborough</city>
        <zip>K9J 0B2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Pointe Claire</city>
        <zip>H9R 4S3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Quebec City</city>
        <zip>G1N 4V3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Red Deer</city>
        <zip>T4N 6V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sherbrooke</city>
        <zip>J1J 2G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Toronto</city>
        <zip>M9W 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research and Cardiovascular Corp.</name>
      <address>
        <city>Ponce</city>
        <zip>00717-1322</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Puerto Rico, Inc.</name>
      <address>
        <city>San Juan</city>
        <zip>00909</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <results_first_submitted>June 9, 2020</results_first_submitted>
  <results_first_submitted_qc>June 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 26, 2020</results_first_posted>
  <disposition_first_submitted>May 8, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 8, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 25, 2015</disposition_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spironolactone</mesh_term>
    <mesh_term>Tadalafil</mesh_term>
    <mesh_term>Mineralocorticoid Receptor Antagonists</mesh_term>
    <mesh_term>Mineralocorticoids</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants entered at lead-in for wash out and a placebo run-in period prior to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>6 Milligrams (mg) LY2623091</title>
          <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="P3">
          <title>13 mg LY2623091</title>
          <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="P4">
          <title>24.5 mg LY2623091</title>
          <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="P5">
          <title>13 mg LY2623091 + 20 mg Tadalafil</title>
          <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="P6">
          <title>20 mg Tadalafil</title>
          <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="P7">
          <title>Spironolactone</title>
          <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 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="51"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="52"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="51"/>
                <participants group_id="P6" count="25"/>
                <participants group_id="P7" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="51"/>
                <participants group_id="P6" count="25"/>
                <participants group_id="P7" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="41"/>
                <participants group_id="P5" count="42"/>
                <participants group_id="P6" count="21"/>
                <participants group_id="P7" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="4"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" 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="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discontinued follow-up period</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least 1 dose of a study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>6 mg LY2623091</title>
          <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="B3">
          <title>13 mg LY2623091</title>
          <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="B4">
          <title>24.5 mg LY2623091</title>
          <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="B5">
          <title>13 mg LY2623091 + 20 mg Tadalafil</title>
          <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="B6">
          <title>20 mg Tadalafil</title>
          <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="B7">
          <title>Spironolactone</title>
          <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="B8">
          <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="51"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="51"/>
            <count group_id="B6" value="25"/>
            <count group_id="B7" value="26"/>
            <count group_id="B8" value="303"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.6" spread="9.4"/>
                    <measurement group_id="B2" value="56.6" spread="11.4"/>
                    <measurement group_id="B3" value="58.0" spread="8.8"/>
                    <measurement group_id="B4" value="58.7" spread="8.8"/>
                    <measurement group_id="B5" value="57.9" spread="9.5"/>
                    <measurement group_id="B6" value="54.0" spread="8.9"/>
                    <measurement group_id="B7" value="59.0" spread="11.0"/>
                    <measurement group_id="B8" value="57.7" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="19"/>
                    <measurement group_id="B8" value="190"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="43"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="23"/>
                    <measurement group_id="B8" value="250"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="33"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="26"/>
                  </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 group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="35"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="187"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="5"/>
                  </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 group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="35"/>
                    <measurement group_id="B5" value="38"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="21"/>
                    <measurement group_id="B8" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Puerto Rico</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kilogram/square meter (kg/m2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.5" spread="4.5"/>
                    <measurement group_id="B2" value="30.2" spread="5.2"/>
                    <measurement group_id="B3" value="30.2" spread="4.9"/>
                    <measurement group_id="B4" value="32.7" spread="4.5"/>
                    <measurement group_id="B5" value="29.5" spread="4.7"/>
                    <measurement group_id="B6" value="29.6" spread="4.2"/>
                    <measurement group_id="B7" value="31.4" spread="4.5"/>
                    <measurement group_id="B8" value="30.6" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic Kidney Disease (CKD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Y</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="49"/>
                    <measurement group_id="B5" value="51"/>
                    <measurement group_id="B6" value="23"/>
                    <measurement group_id="B7" value="24"/>
                    <measurement group_id="B8" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Anti-Hypertensive Medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="10"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="20"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="13"/>
                    <measurement group_id="B8" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Y</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>N</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="46"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="22"/>
                    <measurement group_id="B8" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline in Seated Systolic Blood Pressure (SBP)</title>
          <units>millimeter of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="25"/>
                    <count group_id="B7" value="26"/>
                    <count group_id="B8" value="303"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="151.2" spread="8.8"/>
                    <measurement group_id="B2" value="150.8" spread="8.6"/>
                    <measurement group_id="B3" value="153.7" spread="8.3"/>
                    <measurement group_id="B4" value="150.7" spread="10.2"/>
                    <measurement group_id="B5" value="152.1" spread="9.6"/>
                    <measurement group_id="B6" value="151.7" spread="9.6"/>
                    <measurement group_id="B7" value="153.4" spread="9.0"/>
                    <measurement group_id="B8" value="151.9" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline in Seated Diastolic Blood Pressure (DBP)</title>
          <population>All randomized participants receiving at least 1 dose of a study drug and had baseline seated Diastolic Blood Pressure data.</population>
          <units>millimeter of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="49"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="49"/>
                    <count group_id="B5" value="51"/>
                    <count group_id="B6" value="24"/>
                    <count group_id="B7" value="25"/>
                    <count group_id="B8" value="300"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89.8" spread="8.8"/>
                    <measurement group_id="B2" value="88.2" spread="9.7"/>
                    <measurement group_id="B3" value="90.5" spread="9.5"/>
                    <measurement group_id="B4" value="88.5" spread="8.5"/>
                    <measurement group_id="B5" value="90.6" spread="8.9"/>
                    <measurement group_id="B6" value="91.5" spread="8.8"/>
                    <measurement group_id="B7" value="88.6" spread="11.6"/>
                    <measurement group_id="B8" value="89.6" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)</title>
        <description>Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.</description>
        <time_frame>Baseline, 4 Weeks</time_frame>
        <population>All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for SBP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 mg LY2623091</title>
            <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>13 mg LY2623091</title>
            <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>24.5 mg LY2623091</title>
            <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O5">
            <title>13 mg LY2623091 + 20 mg Tadalafil</title>
            <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O6">
            <title>20 mg Tadalafil</title>
            <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Spironolactone</title>
            <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)</title>
          <description>Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.</description>
          <population>All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for SBP.</population>
          <units>millimeter of mercury (mmHg)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="41"/>
                <count group_id="O5" value="43"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="11.6"/>
                    <measurement group_id="O2" value="-13.1" spread="11.2"/>
                    <measurement group_id="O3" value="-14.6" spread="12.3"/>
                    <measurement group_id="O4" value="-14.3" spread="13.6"/>
                    <measurement group_id="O5" value="-11.8" spread="12.5"/>
                    <measurement group_id="O6" value="-7.1" spread="13.3"/>
                    <measurement group_id="O7" value="-15.4" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)</title>
        <description>Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.</description>
        <time_frame>Baseline, 4 Weeks</time_frame>
        <population>All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for DBP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 mg LY2623091</title>
            <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>13 mg LY2623091</title>
            <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>24.5 mg LY2623091</title>
            <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O5">
            <title>13 mg LY2623091 + 20 mg Tadalafil</title>
            <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O6">
            <title>20 mg Tadalafil</title>
            <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Spironolactone</title>
            <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)</title>
          <description>Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.</description>
          <population>All randomized participants receiving at least 1 dose of the study drug and had baseline and post baseline evaluable data for DBP.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="41"/>
                <count group_id="O5" value="43"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="7.9"/>
                    <measurement group_id="O2" value="-5.6" spread="9.2"/>
                    <measurement group_id="O3" value="-4.8" spread="7.2"/>
                    <measurement group_id="O4" value="-7.1" spread="7.6"/>
                    <measurement group_id="O5" value="-6.8" spread="8.7"/>
                    <measurement group_id="O6" value="-6.6" spread="8.7"/>
                    <measurement group_id="O7" value="-1.2" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)</title>
        <description>The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).</description>
        <time_frame>Baseline, 4 Weeks</time_frame>
        <population>All randomized participants receiving at least 1 dose of the study drug and had evaluable data for 24 hour ABPM.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 mg LY2623091</title>
            <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>13 mg LY2623091</title>
            <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>24.5 mg LY2623091</title>
            <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O5">
            <title>13 mg LY2623091 + 20 mg Tadalafil</title>
            <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O6">
            <title>20 mg Tadalafil</title>
            <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Spironolactone</title>
            <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)</title>
          <description>The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).</description>
          <population>All randomized participants receiving at least 1 dose of the study drug and had evaluable data for 24 hour ABPM.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="39"/>
                <count group_id="O4" value="33"/>
                <count group_id="O5" value="36"/>
                <count group_id="O6" value="19"/>
                <count group_id="O7" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="11.3"/>
                    <measurement group_id="O2" value="-4.9" spread="8.7"/>
                    <measurement group_id="O3" value="-11.1" spread="8.9"/>
                    <measurement group_id="O4" value="-10.4" spread="11.4"/>
                    <measurement group_id="O5" value="-10.4" spread="11.6"/>
                    <measurement group_id="O6" value="-6.3" spread="8.9"/>
                    <measurement group_id="O7" value="-6.4" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="7.7"/>
                    <measurement group_id="O2" value="-1.7" spread="6.3"/>
                    <measurement group_id="O3" value="-4.7" spread="6.1"/>
                    <measurement group_id="O4" value="-3.4" spread="4.8"/>
                    <measurement group_id="O5" value="-6.2" spread="8.0"/>
                    <measurement group_id="O6" value="-5.6" spread="4.9"/>
                    <measurement group_id="O7" value="-2.0" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline to 4 Weeks in Serum Potassium</title>
        <description>Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment*visit and race.</description>
        <time_frame>Baseline, 4 Weeks</time_frame>
        <population>All randomized participants receiving at least 1 dose of the study drug and had evaluable data for serum potassium.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>6 mg LY2623091</title>
            <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>13 mg LY2623091</title>
            <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>24.5 mg LY2623091</title>
            <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O5">
            <title>13 mg LY2623091 + 20 mg Tadalafil</title>
            <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O6">
            <title>20 mg Tadalafil</title>
            <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O7">
            <title>Spironolactone</title>
            <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to 4 Weeks in Serum Potassium</title>
          <description>Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment*visit and race.</description>
          <population>All randomized participants receiving at least 1 dose of the study drug and had evaluable data for serum potassium.</population>
          <units>millimoles/L (mmol/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="45"/>
                <count group_id="O3" value="43"/>
                <count group_id="O4" value="41"/>
                <count group_id="O5" value="44"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.06"/>
                    <measurement group_id="O2" value="0.10" spread="0.06"/>
                    <measurement group_id="O3" value="0.11" spread="0.06"/>
                    <measurement group_id="O4" value="0.25" spread="0.06"/>
                    <measurement group_id="O5" value="0.10" spread="0.06"/>
                    <measurement group_id="O6" value="-0.06" spread="0.08"/>
                    <measurement group_id="O7" value="0.30" spread="0.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091</title>
        <time_frame>2 hours post-dose at 4 Weeks</time_frame>
        <population>All participants who had evaluable PK data of LY2623091.</population>
        <group_list>
          <group group_id="O1">
            <title>6 mg LY2623091</title>
            <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>13 mg LY2623091</title>
            <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O3">
            <title>24.5 mg LY2623091</title>
            <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
          <group group_id="O4">
            <title>13 mg LY2623091 + 20 mg Tadalafil</title>
            <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091</title>
          <population>All participants who had evaluable PK data of LY2623091.</population>
          <units>nanogram/milliliter (ng/ml)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122" spread="32"/>
                    <measurement group_id="O2" value="228" spread="37"/>
                    <measurement group_id="O3" value="379" spread="51"/>
                    <measurement group_id="O4" value="206" spread="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All randomized participants who received at least 1 dose of study drug. One participant was randomized but never dosed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="E2">
          <title>6 mg LY2623091</title>
          <description>6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="E3">
          <title>13 mg LY2623091</title>
          <description>13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="E4">
          <title>24.5 mg LY2623091</title>
          <description>24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="E5">
          <title>13 mg LY2623091 + 20 mg Tadalafil</title>
          <description>13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="E6">
          <title>20 mg Tadalafil</title>
          <description>20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.</description>
        </group>
        <group group_id="E7">
          <title>Spironolactone</title>
          <description>25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="51"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="49"/>
                <counts group_id="E5" subjects_affected="34" subjects_at_risk="51"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="25"/>
                <counts group_id="E7" subjects_affected="12" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Neutrophilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bundle branch block right</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Scleral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Faecal incontinence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Non-alcoholic steatohepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Bronchitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Joint abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood pressure abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Electrocardiogram t wave inversion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="51"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Spontaneous penile erection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Paranasal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Transient acantholytic dermatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </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 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT02194465
org study id: 15525
secondary id: I7T-MC-RMAH
nct id: NCT02194465
lead sponsor: 
has dmc: No
The main purpose of this study is to evaluate the safety and effectiveness of the study drug
      known as LY2623091 in participants with high blood pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline to 4 Weeks in Seated Systolic Blood Pressure (SBP)
time frame: Baseline, 4 Weeks
description: Change from baseline in SBP as measured by a cuff. Least squares (LS) mean change from baseline was calculated using a mixed model repeating measures (MMRM) with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
measure: Change From Baseline to 4 Weeks in Seated Diastolic Blood Pressure (DBP)
time frame: Baseline, 4 Weeks
description: Change from baseline in DBP as measured by a cuff. LS mean change from baseline was calculated using a MMRM with treatment, country, visit, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
measure: Change From Baseline to 4 Weeks in 24 Hour Ambulatory Blood Pressure Monitoring (ABPM)
time frame: Baseline, 4 Weeks
description: The LS mean change in blood pressure is calculated after adjusting for baseline, treatment and race using an analysis of covariance (ANCOVA).
measure: Change From Baseline to 4 Weeks in Serum Potassium
time frame: Baseline, 4 Weeks
description: Potassium measurement as measured by standard laboratory tests. The LS mean change in potassium is calculated using MMRM with adjustment for baseline, treatment, visit, treatment*visit and race.
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2623091
time frame: 2 hours post-dose at 4 Weeks
arm group label: 6 milligrams (mg) LY2623091
arm group type: Experimental
description: 6 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
arm group label: 13 mg LY2623091
arm group type: Experimental
description: 13 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
arm group label: 24.5 mg LY2623091
arm group type: Experimental
description: 24.5 mg LY2623091 with placebo for blinding administered orally once daily for 4 weeks.
arm group label: 13 mg LY2623091 + 20 mg tadalafil
arm group type: Experimental
description: 13 mg LY2623091 and 20 mg of tadalafil with placebo for blinding administered orally once daily for 4 weeks.
arm group label: 20 mg tadalafil
arm group type: Experimental
description: 20 mg tadalafil with placebo for blinding administered orally once daily for 4 weeks.
arm group label: Spironolactone
arm group type: Active Comparator
description: 25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for blinding administered orally once daily for 4 weeks.
intervention type: Drug
intervention name: LY2623091
description: Administered orally
arm group label: 13 mg LY2623091
arm group label: 13 mg LY2623091 + 20 mg tadalafil
arm group label: 24.5 mg LY2623091
arm group label: 6 milligrams (mg) LY2623091
other name: Mineralocorticoid Receptor Antagonist
intervention type: Drug
intervention name: Tadalafil
description: Administered orally
arm group label: 13 mg LY2623091 + 20 mg tadalafil
arm group label: 20 mg tadalafil
other name: LY450190
intervention type: Drug
intervention name: Spironolactone
description: Administered orally
arm group label: Spironolactone
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: 13 mg LY2623091
arm group label: 13 mg LY2623091 + 20 mg tadalafil
arm group label: 20 mg tadalafil
arm group label: 24.5 mg LY2623091
arm group label: 6 milligrams (mg) LY2623091
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Canada
country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
mesh term: Spironolactone
mesh term: Tadalafil
mesh term: Mineralocorticoid Receptor Antagonists
mesh term: Mineralocorticoids
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org
participant flow: 
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reported events: 
certain agreements: 
point of contact: 