<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/NCT02224846</url>
  </required_header>
  <id_info>
    <org_study_id>15382</org_study_id>
    <secondary_id>H6D-GH-B022</secondary_id>
    <nct_id>NCT02224846</nct_id>
  </id_info>
  <brief_title>A Study of Tadalafil (LY450190) in Chinese Men With Erectile Dysfunction</brief_title>
  <official_title>Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction</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 purpose of this study is to evaluate the safety and effectiveness of the study drug,&#xD;
      taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED).&#xD;
      The study will last about up to 25 months for each participant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)</measure>
    <time_frame>Baseline through Month 12</time_frame>
    <description>A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation</measure>
    <time_frame>Baseline through Month 12</time_frame>
    <description>Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score</measure>
    <time_frame>Baseline, Month 1; Baseline, Month 3</time_frame>
    <description>IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments</measure>
    <time_frame>Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24</time_frame>
    <description>IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With &quot;Yes&quot; Responses to Sexual Encounter Profile (SEP) Diary</measure>
    <time_frame>Month 1, Month 3</time_frame>
    <description>Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Normal Erectile Functioning</measure>
    <time_frame>Month 1, Month 3</time_frame>
    <description>Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of &gt;=26) at Month 1 and Month 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments</measure>
    <time_frame>Month 6, Month 12, Month 18, Month 24</time_frame>
    <description>Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of &gt;=26) at Month 6 and Month 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With &quot;Yes&quot; Responses to Global Assessment Questions (GAQ)1 and GAQ2</measure>
    <time_frame>Month 3, Month12, Month 24</time_frame>
    <description>Participants with &quot;yes&quot; responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.&#xD;
GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">635</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>2.5 mg/5 mg tadalafil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 mg tadalafil</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>2.5 mg/5 mg tadalafil</arm_group_label>
    <arm_group_label>5 mg tadalafil</arm_group_label>
    <other_name>LY450190</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a history of erectile dysfunction for at least 3 months.&#xD;
&#xD;
          -  Are sexually active and willing to remain sexually active with the same female partner&#xD;
             during the study.&#xD;
&#xD;
          -  Are willing to have 4 or more attempts of sexual intercourse with female partner&#xD;
             between screening and first treatment start day.&#xD;
&#xD;
          -  Are willing to stay away from any other medicines that the participants were already&#xD;
             taking for erectile dysfunction during this study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have erectile dysfunction, which is caused by any other primary sexual disorder.&#xD;
&#xD;
          -  Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central&#xD;
             nervous system (study doctor will discuss with participants).&#xD;
&#xD;
          -  Have a penis deformity or penile implant that in the opinion of the participants'&#xD;
             doctor is significant.&#xD;
&#xD;
          -  Have human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Are using certain kinds of medicines, which are not allowed in this study.&#xD;
&#xD;
          -  Are allergic to tadalafil.&#xD;
&#xD;
          -  Are planning to father a baby or are in a relationship with a pregnant partner.&#xD;
&#xD;
          -  Are participating or discontinued participation in the past 30 days from any another&#xD;
             clinical trial, which is not compatible with this trial.&#xD;
&#xD;
          -  Have participated or discontinued from any other tadalafil clinical trial.&#xD;
&#xD;
          -  Have a history of drug, alcohol, or substance abuse within the past 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>69 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>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>Beijing</city>
        <zip>100020</zip>
        <country>China</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>Changchun</city>
        <zip>130021</zip>
        <country>China</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>Changsha</city>
        <zip>410011</zip>
        <country>China</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>Chengdu</city>
        <zip>610083</zip>
        <country>China</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>Chongqing</city>
        <zip>400037</zip>
        <country>China</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>Fuzhou</city>
        <zip>350001</zip>
        <country>China</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>Guangzhou</city>
        <zip>510180</zip>
        <country>China</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>Hangzhou</city>
        <zip>310003</zip>
        <country>China</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>Hefei</city>
        <zip>230022</zip>
        <country>China</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>Nanjing</city>
        <zip>210008</zip>
        <country>China</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>Qingdao</city>
        <zip>266071</zip>
        <country>China</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>Shanghai</city>
        <zip>200092</zip>
        <country>China</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>Suzhou City</city>
        <zip>215004</zip>
        <country>China</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>Wenzhou</city>
        <zip>325035</zip>
        <country>China</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>Wu Han</city>
        <zip>430030</zip>
        <country>China</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>Wuhan</city>
        <zip>430022</zip>
        <country>China</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>Yinchuan</city>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>May 25, 2017</results_first_submitted>
  <results_first_submitted_qc>October 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 27, 2017</results_first_posted>
  <last_update_submitted>September 5, 2019</last_update_submitted>
  <last_update_submitted_qc>September 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2019</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>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</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 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>
      <group_list>
        <group group_id="P1">
          <title>2.5 mg/5 mg Tadalafil</title>
          <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
        </group>
        <group group_id="P2">
          <title>5 mg Tadalafil</title>
          <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (Month 3)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="211"/>
                <participants group_id="P2" count="424"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="210"/>
                <participants group_id="P2" count="421"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="192"/>
                <participants group_id="P2" count="388"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2 (Month 3 to Month 12)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="192"/>
                <participants group_id="P2" count="388"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="357"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2 (Month 12 to Month 24)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="357"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="283"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="43"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>2.5 mg/5 mg Tadalafil</title>
          <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
        </group>
        <group group_id="B2">
          <title>5 mg Tadalafil</title>
          <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
        </group>
        <group group_id="B3">
          <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="211"/>
            <count group_id="B2" value="424"/>
            <count group_id="B3" value="635"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.6" spread="11.11"/>
                    <measurement group_id="B2" value="44.1" spread="10.90"/>
                    <measurement group_id="B3" value="43.6" spread="10.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="211"/>
                    <measurement group_id="B2" value="424"/>
                    <measurement group_id="B3" value="635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="211"/>
                    <measurement group_id="B2" value="424"/>
                    <measurement group_id="B3" value="635"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_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_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>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="211"/>
                    <measurement group_id="B2" value="424"/>
                    <measurement group_id="B3" value="635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)</title>
        <description>A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.</description>
        <time_frame>Baseline through Month 12</time_frame>
        <population>All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)</title>
          <description>A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.</description>
          <population>All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="421"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.8"/>
                    <measurement group_id="O2" value="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation</title>
        <description>Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.</description>
        <time_frame>Baseline through Month 12</time_frame>
        <population>All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation</title>
          <description>Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.</description>
          <population>All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="421"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score</title>
        <description>IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.</description>
        <time_frame>Baseline, Month 1; Baseline, Month 3</time_frame>
        <population>All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score</title>
          <description>IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.</description>
          <population>All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
          <units>units on a scale</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="203"/>
                <count group_id="O2" value="414"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="414"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="0.42"/>
                    <measurement group_id="O2" value="6.2" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" spread="0.44"/>
                    <measurement group_id="O2" value="7.4" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments</title>
        <description>IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.</description>
        <time_frame>Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24</time_frame>
        <population>All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments</title>
          <description>IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.</description>
          <population>All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
          <units>units on a scale</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="203"/>
                <count group_id="O2" value="414"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="0.38"/>
                    <measurement group_id="O2" value="7.9" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="361"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="0.43"/>
                    <measurement group_id="O2" value="7.9" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="166"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="0.39"/>
                    <measurement group_id="O2" value="8.3" spread="0.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="326"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="0.44"/>
                    <measurement group_id="O2" value="8.5" spread="0.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With &quot;Yes&quot; Responses to Sexual Encounter Profile (SEP) Diary</title>
        <description>Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.</description>
        <time_frame>Month 1, Month 3</time_frame>
        <population>All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With &quot;Yes&quot; Responses to Sexual Encounter Profile (SEP) Diary</title>
          <description>Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.</description>
          <population>All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
          <units>Percentage of participants</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="412"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Q2: successful penetration,Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.3" spread="34.58"/>
                    <measurement group_id="O2" value="86.7" spread="27.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q2: successful penetration,Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.2" spread="28.55"/>
                    <measurement group_id="O2" value="91.7" spread="23.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3: successful intercourse,Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" spread="41.48"/>
                    <measurement group_id="O2" value="49.5" spread="42.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q3: successful intercourse,Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.7" spread="43.19"/>
                    <measurement group_id="O2" value="60.1" spread="42.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4: satisfied with erection, Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.8" spread="35.62"/>
                    <measurement group_id="O2" value="35.5" spread="41.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q4: satisfied with erection, Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9" spread="43.73"/>
                    <measurement group_id="O2" value="43.5" spread="43.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5: satisfied with sexual experience,Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" spread="32.81"/>
                    <measurement group_id="O2" value="31.1" spread="40.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Q5: satisfied with sexual experience,Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.7" spread="41.93"/>
                    <measurement group_id="O2" value="39.2" spread="43.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Normal Erectile Functioning</title>
        <description>Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of &gt;=26) at Month 1 and Month 3.</description>
        <time_frame>Month 1, Month 3</time_frame>
        <population>All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Normal Erectile Functioning</title>
          <description>Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of &gt;=26) at Month 1 and Month 3.</description>
          <population>All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
          <units>Percentage of partcipants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="421"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="203"/>
                    <count group_id="O2" value="414"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2"/>
                    <measurement group_id="O2" value="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.6"/>
                    <measurement group_id="O2" value="37.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments</title>
        <description>Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of &gt;=26) at Month 6 and Month 12.</description>
        <time_frame>Month 6, Month 12, Month 18, Month 24</time_frame>
        <population>All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments</title>
          <description>Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of &gt;=26) at Month 6 and Month 12.</description>
          <population>All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="421"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="376"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.2"/>
                    <measurement group_id="O2" value="42.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="361"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1"/>
                    <measurement group_id="O2" value="43.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="166"/>
                    <count group_id="O2" value="341"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6"/>
                    <measurement group_id="O2" value="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="326"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.5"/>
                    <measurement group_id="O2" value="48.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With &quot;Yes&quot; Responses to Global Assessment Questions (GAQ)1 and GAQ2</title>
        <description>Participants with &quot;yes&quot; responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.&#xD;
GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?</description>
        <time_frame>Month 3, Month12, Month 24</time_frame>
        <population>All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2.</population>
        <group_list>
          <group group_id="O1">
            <title>2.5 mg/5 mg Tadalafil</title>
            <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
          </group>
          <group group_id="O2">
            <title>5 mg Tadalafil</title>
            <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With &quot;Yes&quot; Responses to Global Assessment Questions (GAQ)1 and GAQ2</title>
          <description>Participants with &quot;yes&quot; responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.&#xD;
GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?</description>
          <population>All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="211"/>
                <count group_id="O2" value="424"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 3: GAQ1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="392"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.6"/>
                    <measurement group_id="O2" value="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: GAQ1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="361"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6"/>
                    <measurement group_id="O2" value="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24: GAQ1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="326"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8"/>
                    <measurement group_id="O2" value="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3: GAQ2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                    <count group_id="O2" value="392"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.5"/>
                    <measurement group_id="O2" value="92.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12: GAQ2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="361"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5"/>
                    <measurement group_id="O2" value="96.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 24: GAQ2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="326"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.2"/>
                    <measurement group_id="O2" value="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All the participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>2.5 mg/5 mg Tadalafil</title>
          <description>2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).</description>
        </group>
        <group group_id="E2">
          <title>5 mg Tadalafil</title>
          <description>5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</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="15" subjects_at_risk="210"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Maculopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Duodenal ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hepatic cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Urethral stricture postoperative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ankylosing spondylitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Varicocele</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="86" subjects_at_risk="210"/>
                <counts group_id="E2" subjects_affected="178" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hypertensive heart disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Microvascular coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial septal defect</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Eustachian tube dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Mixed deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Thyroid mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Eye disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Xerophthalmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastric dilatation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastric polyps</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tooth disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Cholecystitis chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Fatty liver alcoholic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hepatic cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Conjunctivitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dermatophytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Helicobacter infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hepatitis b</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Mumps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tinea cruris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tinea infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tinea manuum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="25" subjects_affected="21" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="24" subjects_affected="18" subjects_at_risk="210"/>
                <counts group_id="E2" events="48" subjects_affected="39" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Electrical burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Heat stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Lip injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Peripheral nerve injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood urea increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>High density lipoprotein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Lipids increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Folate deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </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="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Arthropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Exostosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Vertebral lesion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Cerebral artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Poor quality sleep</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Vertebrobasilar insufficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Pregnancy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Premature ejaculation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Renal mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Urethral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Balanoposthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Epididymal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="210"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Nasal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Nasal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Reflux laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Stasis dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Breast feeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="210"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="421"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="210"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="421"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="210"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="421"/>
              </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>
      <email>ClinicalTrials.gov@lilly.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224846
org study id: 15382
secondary id: H6D-GH-B022
nct id: NCT02224846
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and effectiveness of the study drug,
      taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED).
      The study will last about up to 25 months for each participant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
time frame: Baseline through Month 12
description: A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
measure: Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
time frame: Baseline through Month 12
description: Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
measure: Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
time frame: Baseline, Month 1; Baseline, Month 3
description: IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
measure: Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
time frame: Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24
description: IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline*visit, where participant is a random effect.
measure: Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary
time frame: Month 1, Month 3
description: Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
measure: Percentage of Participants Achieving Normal Erectile Functioning
time frame: Month 1, Month 3
description: Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 1 and Month 3.
measure: Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
time frame: Month 6, Month 12, Month 18, Month 24
description: Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of >=26) at Month 6 and Month 12.
measure: Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2
time frame: Month 3, Month12, Month 24
description: Participants with "yes" responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12.
GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?
arm group label: 2.5 mg/5 mg tadalafil
arm group type: Experimental
description: 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
arm group label: 5 mg tadalafil
arm group type: Experimental
description: 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
intervention type: Drug
intervention name: Tadalafil
description: Administered orally
arm group label: 2.5 mg/5 mg tadalafil
arm group label: 5 mg tadalafil
other name: LY450190
criteria: 
gender: Male
minimum age: 22 Years
maximum age: 69 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: China
responsible party type: Sponsor
mesh term: Erectile Dysfunction
mesh term: Tadalafil
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 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: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 