<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/NCT01663740</url>
  </required_header>
  <id_info>
    <org_study_id>WV25651</org_study_id>
    <nct_id>NCT01663740</nct_id>
  </id_info>
  <brief_title>A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls</brief_title>
  <official_title>A Multicenter Prospective Cohort Study to Investigate if Ganciclovir Significantly Affects Spermatogenesis in Adult Male Renal Transplant Recipients Receiving up to 200 Days Valganciclovir Vs. Concurrent Untreated Matched Controls</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This observational study will compare spermatogenesis in male adult renal transplant&#xD;
      recipients receiving valganciclovir versus untreated matched controls. Data will be collected&#xD;
      from each participant for up to 52 weeks post transplant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2012</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">September 29, 2015</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Sperm Density From Baseline to the End of Treatment (EOT)</measure>
    <time_frame>Baseline, EOT (Week 28)</time_frame>
    <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TUNEL Score From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Seminal Volume From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Seminal Volume From EOT to End FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sperm Density From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sperm Density From Baseline to End of FU</measure>
    <time_frame>Baseline, end of FU (Week 52)</time_frame>
    <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Motility of Sperm From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Motility of Sperm From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Testosterone Level From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Total Testosterone Level From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LH Level From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LH Level From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FSH Level From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FSH Level From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Prolactin Level From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Prolactin Level From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Inhibin B Level From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Inhibin B Level From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Abnormal Sperm Density (&lt;20 Mil/mL) From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Abnormal sperm density was considered as sperm density less than (&lt;) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Abnormal Sperm Density (&lt;20 Mil/mL) From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Abnormal sperm density was considered as sperm density &lt;20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improved TUNEL Score From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU</measure>
    <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Participants who had higher sperm density compared with the previous visit were considered as improved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Improved Sperm Density From EOT to End of FU</measure>
    <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
    <description>Participants who had higher sperm density compared with the previous visit were considered as improved.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Cytomegalovirus Infections</condition>
  <arm_group>
    <arm_group_label>Cohort A: Partcipants who Received Valganciclovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who receive valganciclovir prophylaxis according to the local prescribing information, will be observed for spermatogenesis up to 52 weeks post-transplant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B: Untreated Participants</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valganciclovir</intervention_name>
    <description>Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.</description>
    <arm_group_label>Cohort A: Partcipants who Received Valganciclovir</arm_group_label>
    <other_name>Valcyte®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First renal transplant&#xD;
&#xD;
          -  Participant eligible to receive valganciclovir prophylaxis as determined by the&#xD;
             treating physician in accordance with the local approved product prescribing&#xD;
             information (Cohort A only) or the participant is not expected to require any&#xD;
             valganciclovir prophylaxis (Cohort B only) post-transplant&#xD;
&#xD;
          -  Participant has no history of known infertility&#xD;
&#xD;
          -  Participant is able and willing to provide semen samples&#xD;
&#xD;
          -  Participant agrees to utilize a barrier contraceptive throughout the study or for at&#xD;
             least 90 days after cessation of valganciclovir treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior ganciclovir or valganciclovir within 3 months of enrollment&#xD;
&#xD;
          -  Organ transplant other than kidney&#xD;
&#xD;
          -  Participant has received an investigational new drug in the 3 months prior to&#xD;
             transplant&#xD;
&#xD;
          -  Participant hs received an alkylating agent or other medications known to affect&#xD;
             fertility/spermatogenesis&#xD;
&#xD;
          -  Participant is unlikely to be available for follow-up for the entire duration of the&#xD;
             study (up to 52 weeks)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Transplantation</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles (UCLA)</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California at San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Georgia</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western New England Renal &amp; Transplant Associates, P.C.</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Cancer Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University Hospital</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregan Health &amp; Science Univ</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University Department of Nephrology</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Healthcare System of San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miguel Hidalgo</name>
      <address>
        <city>Aguascalientes</city>
        <zip>20230</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Mexicano de Trasplantes</name>
      <address>
        <city>Cuernavaca</city>
        <zip>62448</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Central Dr. Ignacio Morones Prieto</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78240</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>October 2, 2017</results_first_submitted>
  <results_first_submitted_qc>August 1, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2018</results_first_posted>
  <last_update_submitted>August 1, 2018</last_update_submitted>
  <last_update_submitted_qc>August 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</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>Cytomegalovirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valganciclovir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort A: Partcipants Who Received Valganciclovir</title>
          <description>Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
        </group>
        <group group_id="P2">
          <title>Cohort B: Untreated Participants</title>
          <description>Participants with donor negative (D-)/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38">Safety Population</participants>
                <participants group_id="P2" count="21">Safety Population</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inclusion/Exclusion not met</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No end of study status</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population included all participants assigned to a cohort. One participant who was considered for inclusion in the study but did not participate, was excluded from baseline analysis.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort A: Partcipants Who Received Valganciclovir</title>
          <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
        </group>
        <group group_id="B2">
          <title>Cohort B: Untreated Participants</title>
          <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</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="37"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.6" spread="7.96"/>
                    <measurement group_id="B2" value="32.5" spread="5.81"/>
                    <measurement group_id="B3" value="34.5" spread="7.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                    <count group_id="B2" value="21"/>
                    <count group_id="B3" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="37"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Seminal Volume</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>milliliters (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.4" spread="1.51"/>
                    <measurement group_id="B2" value="2.0" spread="1.37"/>
                    <measurement group_id="B3" value="2.2" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sperm Density</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>millions of sperm/milliliter (mil/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.0" spread="28.33"/>
                    <measurement group_id="B2" value="23.2" spread="24.90"/>
                    <measurement group_id="B3" value="21.9" spread="26.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percentage of Normal Sperm Cells</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>percentage of normal sperm cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.4" spread="18.44"/>
                    <measurement group_id="B2" value="33.5" spread="39.03"/>
                    <measurement group_id="B3" value="20.3" spread="30.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Motility of Sperm</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.8" spread="20.46"/>
                    <measurement group_id="B2" value="36.3" spread="24.24"/>
                    <measurement group_id="B3" value="30.0" spread="22.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Terminal Uridine Nick-End Labeling (TUNEL) Score</title>
          <description>TUNEL score represents percentage of sperm with fragmented Deoxyribonucleic acid (DNA); total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.</description>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="28"/>
                    <count group_id="B2" value="18"/>
                    <count group_id="B3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.4" spread="9.80"/>
                    <measurement group_id="B2" value="12.9" spread="10.60"/>
                    <measurement group_id="B3" value="13.8" spread="10.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Follicle Stimulating Hormone (FSH) Level</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>units per liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.8" spread="6.77"/>
                    <measurement group_id="B2" value="8.6" spread="6.61"/>
                    <measurement group_id="B3" value="9.9" spread="6.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Luteinizing Hormone (LH) Level</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>milliunits per milliliter (mU/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.4" spread="2.61"/>
                    <measurement group_id="B2" value="6.8" spread="6.86"/>
                    <measurement group_id="B3" value="6.6" spread="4.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prolactin Level</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>mU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="175.4" spread="73.51"/>
                    <measurement group_id="B2" value="164.5" spread="46.22"/>
                    <measurement group_id="B3" value="170.9" spread="63.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Testosterone Level</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>nanomoles per liter (nmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="49"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.2" spread="5.83"/>
                    <measurement group_id="B2" value="11.3" spread="5.54"/>
                    <measurement group_id="B3" value="13.0" spread="5.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Inhibin B Level</title>
          <population>Number analyzed indicates number of participants evaluated for this analysis.</population>
          <units>picograms per milliliter (pg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="19"/>
                    <count group_id="B3" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103.4" spread="55.82"/>
                    <measurement group_id="B2" value="149.1" spread="98.45"/>
                    <measurement group_id="B3" value="122.3" spread="78.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Sperm Density From Baseline to the End of Treatment (EOT)</title>
        <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).</description>
        <time_frame>Baseline, EOT (Week 28)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sperm Density From Baseline to the End of Treatment (EOT)</title>
          <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>mil/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.770" spread="9.0518"/>
                    <measurement group_id="O2" value="30.396" spread="11.3044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0075</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-40.166</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>14.1387</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-68.869</ci_lower_limit>
            <ci_upper_limit>-11.463</ci_upper_limit>
            <estimate_desc>Change in sperm density from Baseline to EOT</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)</title>
        <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)</title>
          <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>percent score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.595" spread="1.7720"/>
                    <measurement group_id="O2" value="-5.354" spread="2.0680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.516" spread="1.9542"/>
                    <measurement group_id="O2" value="-3.465" spread="2.5475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5109</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>1.758</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.6460</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.619</ci_lower_limit>
            <ci_upper_limit>7.135</ci_upper_limit>
            <estimate_desc>Change in TUNEL score from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7449</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-1.051</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.2058</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.566</ci_lower_limit>
            <ci_upper_limit>5.464</ci_upper_limit>
            <estimate_desc>Change in TUNEL score from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in TUNEL Score From EOT to End of FU</title>
        <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in TUNEL Score From EOT to End of FU</title>
          <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>percent score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.447" spread="2.0671"/>
                    <measurement group_id="O2" value="1.578" spread="2.5315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3940</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline TUNEL score,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>2.869</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.2934</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.001</ci_lower_limit>
            <ci_upper_limit>9.739</ci_upper_limit>
            <estimate_desc>Change in TUNEL score from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Seminal Volume From Baseline to EOT and End of FU</title>
        <description>Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Seminal Volume From Baseline to EOT and End of FU</title>
          <description>Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.193" spread="0.2324"/>
                    <measurement group_id="O2" value="-0.347" spread="0.2967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.289" spread="0.2066"/>
                    <measurement group_id="O2" value="-0.161" spread="0.2685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6773</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>0.155</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3687</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.594</ci_lower_limit>
            <ci_upper_limit>0.903</ci_upper_limit>
            <estimate_desc>Change in seminal volume from Basline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7046</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-0.128</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3343</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.806</ci_lower_limit>
            <ci_upper_limit>0.551</ci_upper_limit>
            <estimate_desc>Change in seminal volume from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Seminal Volume From EOT to End FU</title>
        <description>Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Seminal Volume From EOT to End FU</title>
          <description>Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.103" spread="0.2187"/>
                    <measurement group_id="O2" value="0.024" spread="0.3067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7323</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline semen volume,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-0.128</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3684</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.888</ci_lower_limit>
            <ci_upper_limit>0.633</ci_upper_limit>
            <estimate_desc>Change in seminal volume from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sperm Density From EOT to End of FU</title>
        <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sperm Density From EOT to End of FU</title>
          <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>mil/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.149" spread="17.7736"/>
                    <measurement group_id="O2" value="5.882" spread="27.4837"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1756</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>51.267</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>36.6869</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-24.626</ci_lower_limit>
            <ci_upper_limit>127.159</ci_upper_limit>
            <estimate_desc>Change in sperm density from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sperm Density From Baseline to End of FU</title>
        <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).</description>
        <time_frame>Baseline, end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sperm Density From Baseline to End of FU</title>
          <description>Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>mil/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.671" spread="11.6679"/>
                    <measurement group_id="O2" value="49.866" spread="15.8282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6058</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm density,age,&amp; duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-10.195</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>19.5745</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-49.934</ci_lower_limit>
            <ci_upper_limit>29.543</ci_upper_limit>
            <estimate_desc>Change in sperm density from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Motility of Sperm From Baseline to EOT and End of FU</title>
        <description>Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Motility of Sperm From Baseline to EOT and End of FU</title>
          <description>Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.839" spread="5.4259"/>
                    <measurement group_id="O2" value="25.667" spread="6.9723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.736" spread="4.7920"/>
                    <measurement group_id="O2" value="34.538" spread="6.6024"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0222</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-21.828</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.1214</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-40.346</ci_lower_limit>
            <ci_upper_limit>-3.311</ci_upper_limit>
            <estimate_desc>Change in total motility of sperm from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2495</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-9.802</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.3702</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.795</ci_lower_limit>
            <ci_upper_limit>7.190</ci_upper_limit>
            <estimate_desc>Change in total motility of sperm from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Motility of Sperm From EOT to End of FU</title>
        <description>Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Motility of Sperm From EOT to End of FU</title>
          <description>Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>percent motility</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.953" spread="6.3968"/>
                    <measurement group_id="O2" value="20.635" spread="9.0663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3505</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm motility,age,duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-11.683</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>12.2576</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.039</ci_lower_limit>
            <ci_upper_limit>13.674</ci_upper_limit>
            <estimate_desc>Change in total motility of sperm from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU</title>
        <description>Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU</title>
          <description>Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>percentage of normal sperm cells</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.720" spread="4.0233"/>
                    <measurement group_id="O2" value="9.461" spread="5.2737"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.128" spread="2.8907"/>
                    <measurement group_id="O2" value="6.982" spread="4.2060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4021</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-5.741</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.7578</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.524</ci_lower_limit>
            <ci_upper_limit>8.042</ci_upper_limit>
            <estimate_desc>Change in sperm morphology from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7229</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-1.854</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.1817</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.423</ci_lower_limit>
            <ci_upper_limit>8.714</ci_upper_limit>
            <estimate_desc>Change in sperm morphology from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU</title>
        <description>Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU</title>
          <description>Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>percentage of normal sperm cells</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.714" spread="4.3420"/>
                    <measurement group_id="O2" value="2.236" spread="5.8507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7080</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline sperm morphology,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-2.950</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.7598</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.192</ci_lower_limit>
            <ci_upper_limit>13.291</ci_upper_limit>
            <estimate_desc>Change in sperm morphology from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Testosterone Level From Baseline to EOT and End of FU</title>
        <description>Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Testosterone Level From Baseline to EOT and End of FU</title>
          <description>Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.762" spread="1.0203"/>
                    <measurement group_id="O2" value="2.623" spread="1.3586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.395" spread="1.0260"/>
                    <measurement group_id="O2" value="1.509" spread="1.3074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2673</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-1.861</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.6512</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.213</ci_lower_limit>
            <ci_upper_limit>1.491</ci_upper_limit>
            <estimate_desc>Change in total testosterone level from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4949</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-1.114</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.6147</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.392</ci_lower_limit>
            <ci_upper_limit>2.164</ci_upper_limit>
            <estimate_desc>Change in total testosterone level from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Total Testosterone Level From EOT to End of FU</title>
        <description>Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Total Testosterone Level From EOT to End of FU</title>
          <description>Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.936" spread="0.9950"/>
                    <measurement group_id="O2" value="-0.984" spread="1.2012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9753</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline testosterone,age,duration of pre-transplant dialysis as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>0.047</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.5100</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.063</ci_lower_limit>
            <ci_upper_limit>3.157</ci_upper_limit>
            <estimate_desc>Change in total testosterone level from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in LH Level From Baseline to EOT and End of FU</title>
        <description>LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in LH Level From Baseline to EOT and End of FU</title>
          <description>LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>mU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.281" spread="0.3743"/>
                    <measurement group_id="O2" value="-0.357" spread="0.5190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.857" spread="0.2787"/>
                    <measurement group_id="O2" value="-0.642" spread="0.3635"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9053</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>0.076</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6347</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.214</ci_lower_limit>
            <ci_upper_limit>1.366</ci_upper_limit>
            <estimate_desc>Change in LH level from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0104</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-1.215</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.4477</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.125</ci_lower_limit>
            <ci_upper_limit>-0.305</ci_upper_limit>
            <estimate_desc>Change in LH level from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in LH Level From EOT to End of FU</title>
        <description>LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in LH Level From EOT to End of FU</title>
          <description>LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>mU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.482" spread="0.2607"/>
                    <measurement group_id="O2" value="-0.417" spread="0.3207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0143</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline LH concentration,age,&amp; pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-1.065</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.4057</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.899</ci_lower_limit>
            <ci_upper_limit>-0.231</ci_upper_limit>
            <estimate_desc>Change in LH level from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in FSH Level From Baseline to EOT and End of FU</title>
        <description>FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in FSH Level From Baseline to EOT and End of FU</title>
          <description>FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.521" spread="1.0033"/>
                    <measurement group_id="O2" value="-1.020" spread="1.4072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.905" spread="0.4113"/>
                    <measurement group_id="O2" value="-1.922" spread="0.5369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1505</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>2.541</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.7274</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.969</ci_lower_limit>
            <ci_upper_limit>6.052</ci_upper_limit>
            <estimate_desc>Change in FSH level from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1539</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-0.983</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6739</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.352</ci_lower_limit>
            <ci_upper_limit>0.387</ci_upper_limit>
            <estimate_desc>Change in FSH level from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in FSH Level From EOT to End of FU</title>
        <description>FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in FSH Level From EOT to End of FU</title>
          <description>FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.462" spread="0.5036"/>
                    <measurement group_id="O2" value="-1.988" spread="0.6141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0798</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline FSH concentration,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-1.474</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.8084</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.136</ci_lower_limit>
            <ci_upper_limit>0.188</ci_upper_limit>
            <estimate_desc>Change in FSH level from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Prolactin Level From Baseline to EOT and End of FU</title>
        <description>Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Prolactin Level From Baseline to EOT and End of FU</title>
          <description>Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>mU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.590" spread="14.4761"/>
                    <measurement group_id="O2" value="15.693" spread="19.2663"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.829" spread="13.1691"/>
                    <measurement group_id="O2" value="-5.443" spread="16.7203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.9965</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>-0.104</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>23.4660</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.792</ci_lower_limit>
            <ci_upper_limit>47.585</ci_upper_limit>
            <estimate_desc>Change in prolactin level from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.4636</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>15.272</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>20.6031</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.599</ci_lower_limit>
            <ci_upper_limit>57.142</ci_upper_limit>
            <estimate_desc>Change in prolactin level from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Prolactin Level From EOT to End of FU</title>
        <description>Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Prolactin Level From EOT to End of FU</title>
          <description>Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>mU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.429" spread="10.9988"/>
                    <measurement group_id="O2" value="-16.169" spread="13.5322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.6134</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline prolactin level,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>8.740</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>17.0805</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.438</ci_lower_limit>
            <ci_upper_limit>43.917</ci_upper_limit>
            <estimate_desc>Change in prolactin level from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Inhibin B Level From Baseline to EOT and End of FU</title>
        <description>Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inhibin B Level From Baseline to EOT and End of FU</title>
          <description>Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.075" spread="7.3778"/>
                    <measurement group_id="O2" value="-3.067" spread="9.5924"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.416" spread="10.8658"/>
                    <measurement group_id="O2" value="10.734" spread="13.9963"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.5002</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>8.142</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.9301</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.223</ci_lower_limit>
            <ci_upper_limit>32.506</ci_upper_limit>
            <estimate_desc>Change in inhibin B level from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0279</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables.</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>40.682</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>17.6084</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.720</ci_lower_limit>
            <ci_upper_limit>76.643</ci_upper_limit>
            <estimate_desc>Change in inhibin B level from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Inhibin B Level From EOT to End of FU</title>
        <description>Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Inhibin B Level From EOT to End of FU</title>
          <description>Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.329" spread="13.8221"/>
                    <measurement group_id="O2" value="14.448" spread="17.8932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2548</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>Model adjusted for Cohort,visit,Cohort by visit interaction,baseline inhibin B level,age,pre-transplant dialysis duration as explanatory variables</method_desc>
            <param_type>Mean Difference</param_type>
            <param_value>25.881</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>22.1348</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.024</ci_lower_limit>
            <ci_upper_limit>71.786</ci_upper_limit>
            <estimate_desc>Change in inhibin B level from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Abnormal Sperm Density (&lt;20 Mil/mL) From Baseline to EOT and End of FU</title>
        <description>Abnormal sperm density was considered as sperm density less than (&lt;) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Abnormal Sperm Density (&lt;20 Mil/mL) From Baseline to EOT and End of FU</title>
          <description>Abnormal sperm density was considered as sperm density less than (&lt;) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</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="24"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abnormal to abnormal: EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal to abnormal: FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="20.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal to abnormal: EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal to abnormal: FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.3</ci_lower_limit>
            <ci_upper_limit>45.3</ci_upper_limit>
            <estimate_desc>Change in abnormal to abnormal sperm density from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>5.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.3</ci_lower_limit>
            <ci_upper_limit>43.3</ci_upper_limit>
            <estimate_desc>Change in abnormal to abnormal sperm density from Baseline to end of FU</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>17.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.3</ci_lower_limit>
            <ci_upper_limit>48.8</ci_upper_limit>
            <estimate_desc>Change in normal to abnormal sperm density from Baseline to EOT</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Abnormal Sperm Density (&lt;20 Mil/mL) From EOT to End of FU</title>
        <description>Abnormal sperm density was considered as sperm density &lt;20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Abnormal Sperm Density (&lt;20 Mil/mL) From EOT to End of FU</title>
          <description>Abnormal sperm density was considered as sperm density &lt;20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</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="19"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abnormal to abnormal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.3"/>
                    <measurement group_id="O2" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Normal to abnormal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>4.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.5</ci_lower_limit>
            <ci_upper_limit>42.5</ci_upper_limit>
            <estimate_desc>Change in abnormal to abnormal sperm density from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU</title>
        <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU</title>
          <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</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="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7"/>
                    <measurement group_id="O2" value="71.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                    <measurement group_id="O2" value="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.3</ci_lower_limit>
            <ci_upper_limit>33.7</ci_upper_limit>
            <estimate_desc>Improvement from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>6.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.1</ci_lower_limit>
            <ci_upper_limit>44.4</ci_upper_limit>
            <estimate_desc>Improvement from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improved TUNEL Score From EOT to End of FU</title>
        <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improved TUNEL Score From EOT to End of FU</title>
          <description>Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</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="16"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8"/>
                    <measurement group_id="O2" value="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-11.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-50.0</ci_lower_limit>
            <ci_upper_limit>29.3</ci_upper_limit>
            <estimate_desc>Improvement from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU</title>
        <description>Participants who had higher sperm density compared with the previous visit were considered as improved.</description>
        <time_frame>Baseline, EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU</title>
          <description>Participants who had higher sperm density compared with the previous visit were considered as improved.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure. Number analyzed indicates number of participants evaluated for this outcome measure at specified timepoint.</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="24"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EOT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0"/>
                    <measurement group_id="O2" value="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-31.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-59.7</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>Improvement from Baseline to EOT</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-29.7</ci_lower_limit>
            <ci_upper_limit>47.7</ci_upper_limit>
            <estimate_desc>Improvement from Baseline to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Improved Sperm Density From EOT to End of FU</title>
        <description>Participants who had higher sperm density compared with the previous visit were considered as improved.</description>
        <time_frame>EOT (Week 28), end of FU (Week 52)</time_frame>
        <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Partcipants Who Received Valganciclovir</title>
            <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Untreated Participants</title>
            <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Improved Sperm Density From EOT to End of FU</title>
          <description>Participants who had higher sperm density compared with the previous visit were considered as improved.</description>
          <population>Safety population. Overall number of participants analyzed=participants evaluable for this outcome measure.</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="19"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.9"/>
                    <measurement group_id="O2" value="88.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in Percentage</param_type>
            <param_value>-9.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-47.2</ci_lower_limit>
            <ci_upper_limit>27.9</ci_upper_limit>
            <estimate_desc>Improvement from EOT to end of FU</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to end of study (Week 52)</time_frame>
      <desc>Participants who received at least one dose of valganciclovir in Cohort A and all transplanted participants of Cohort B were included for adverse events analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort A: Partcipants Who Received Valganciclovir</title>
          <description>Participants with D+/R- CMV serology, who received valganciclovir prophylaxis according to the local prescribing information, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
        </group>
        <group group_id="E2">
          <title>Cohort B: Untreated Participants</title>
          <description>Participants with D-/R- CMV serology, who did not receive prophylaxis, were observed for spermatogenesis up to 52 weeks post-transplant.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-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="10" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Retroperitoneal hematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Kidney transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foreign body</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Perinephric collection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Fetal death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Renal artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Treatment noncompliance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Polycythaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Transplant rejection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Incision site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Perinephric collection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Immunosuppressant drug level increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Scrotal swelling</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="21"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Wound drainage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="21"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="21"/>
              </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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffmann-La Roche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.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/NCT01663740
org study id: WV25651
nct id: NCT01663740
lead sponsor: 
This observational study will compare spermatogenesis in male adult renal transplant
      recipients receiving valganciclovir versus untreated matched controls. Data will be collected
      from each participant for up to 52 weeks post transplant.
allocation: Randomized
primary purpose: Other
masking: None (Open Label)
measure: Change in Sperm Density From Baseline to the End of Treatment (EOT)
time frame: Baseline, EOT (Week 28)
description: Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (EOT) minus (-) the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).
measure: Change in Terminal Uridine Nick-End Labeling (TUNEL) Score From Baseline to EOT and End of Follow-up (FU)
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at post-baseline visit (EOT and FU) minus the TUNEL score measured at baseline for each participant. A negative change from baseline indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0 percent (%) to 100%, higher score represents more fragmentation.
measure: Change in TUNEL Score From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Change was calculated as the TUNEL score measured at FU minus the TUNEL score measured at EOT for each participant. A negative change from EOT indicated a lower TUNEL score. TUNEL score represents percentage of sperm with fragmented DNA; total score ranged from 0% to 100%, higher score represents more fragmentation.
measure: Change in Seminal Volume From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at post-baseline visit (EOT and FU) - the seminal volume measured at baseline for each participant. A negative change from baseline indicated a lower seminal volume (worsening).
measure: Change in Seminal Volume From EOT to End FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Seminal volume was calculated based on the average of two semen samples. Change was calculated as the seminal volume measured at FU - the seminal volume measured at EOT for each participant. A negative change from EOT indicated a lower seminal volume (worsening).
measure: Change in Sperm Density From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at FU - the sperm density measured at EOT for each participant. A negative change from EOT indicated a lower sperm density (worsening).
measure: Change in Sperm Density From Baseline to End of FU
time frame: Baseline, end of FU (Week 52)
description: Sperm density was calculated based on the average of two semen samples. Change was calculated as the sperm density measured at post-baseline visit (FU) - the sperm density measured at baseline for each participant. A negative change from baseline indicated a lower sperm density (worsening).
measure: Change in Total Motility of Sperm From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at post-baseline visit (EOT and FU) - the sperm motility measured at baseline for each participant. A negative change from baseline indicated a lower sperm motility (worsening).
measure: Change in Total Motility of Sperm From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Sperm motility was calculated based on the average of two semen samples. Percent was determined by the calculation of motile sperm/total sperm count. Change was calculated as the sperm motility measured at FU - the sperm motility measured at EOT for each participant. A negative change from EOT indicated a lower sperm motility (worsening).
measure: Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at post-baseline visit (EOT and FU) - the sperm morphology measured at baseline for each participant. A positive change from baseline indicated an improved sperm morphology.
measure: Change in Sperm Morphology Evaluated as Percentage of Normal Sperm Cells From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Sperm morphology was evaluated based on the average of two semen samples. Change was calculated as the sperm morphology measured at FU - the sperm morphology measured at EOT for each participant. A positive change from EOT indicated an improved sperm morphology.
measure: Change in Total Testosterone Level From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at post-baseline visit (EOT and FU) - the testosterone level measured at baseline for each participant. A negative change from baseline indicated a lower testosterone level.
measure: Change in Total Testosterone Level From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Testosterone level was calculated based on the average of two samples. Change was calculated as the testosterone level measured at FU - the testosterone level measured at EOT for each participant. A negative change from EOT indicated a lower testosterone level.
measure: Change in LH Level From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at post-baseline visit (EOT and FU) - the LH level measured at baseline for each participant. A negative change from baseline indicated a lower LH level.
measure: Change in LH Level From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: LH level was calculated based on the average of two samples. Change was calculated as the LH level measured at FU - the LH level measured at EOT for each participant. A negative change from EOT indicated a lower LH level.
measure: Change in FSH Level From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at post-baseline visit (EOT and FU) - the FSH level measured at baseline for each participant. A negative change from baseline indicated a lower FSH level.
measure: Change in FSH Level From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: FSH level was calculated based on the average of two samples. Change was calculated as the FSH level measured at FU - the FSH level measured at EOT for each participant. A negative change from EOT indicated a lower FSH level.
measure: Change in Prolactin Level From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at post-baseline visit (EOT and FU) - the prolactin level measured at baseline for each participant. A negative change from baseline indicated a lower prolactin level.
measure: Change in Prolactin Level From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Prolactin level was calculated based on the average of two samples. Change was calculated as the prolactin level measured at FU - the prolactin level measured at EOT for each participant. A negative change from EOT indicated a lower prolactin level.
measure: Change in Inhibin B Level From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at post-baseline visit (EOT and FU) - the inhibin B level measured at baseline for each participant. A negative change from baseline indicated a lower inhibin B level.
measure: Change in Inhibin B Level From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Inhibin B level was calculated based on the average of two samples. Change was calculated as the inhibin B level measured at FU - the inhibin B level measured at EOT for each participant. A negative change from EOT indicated a lower inhibin B level.
measure: Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Abnormal sperm density was considered as sperm density less than (<) 20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from baseline to EOT and end of FU was reported.
measure: Percentage of Participants With Abnormal Sperm Density (<20 Mil/mL) From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Abnormal sperm density was considered as sperm density <20 mil/mL. Change in abnormal to abnormal sperm density and normal to abnormal sperm density from EOT to end of FU was reported.
measure: Percentage of Participants With Improved TUNEL Score From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
measure: Percentage of Participants With Improved TUNEL Score From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Sperm DNA fragmentation change (chromatin damage) was evaluated based on TUNEL score. Participants who had a lower TUNEL score compared to the previous time point were considered as improved.
measure: Percentage of Participants With Improved Sperm Density From Baseline to EOT and End of FU
time frame: Baseline, EOT (Week 28), end of FU (Week 52)
description: Participants who had higher sperm density compared with the previous visit were considered as improved.
measure: Percentage of Participants With Improved Sperm Density From EOT to End of FU
time frame: EOT (Week 28), end of FU (Week 52)
description: Participants who had higher sperm density compared with the previous visit were considered as improved.
arm group label: Cohort A: Partcipants who Received Valganciclovir
arm group type: Experimental
description: Participants with donor positive (D+)/recipient negative (R-) cytomegalovirus (CMV) serology, who receive valganciclovir prophylaxis according to the local prescribing information, will be observed for spermatogenesis up to 52 weeks post-transplant.
arm group label: Cohort B: Untreated Participants
arm group type: No Intervention
description: Participants with donor negative (D-)/R- CMV serology, who do not receive prophylaxis, will be observed for spermatogenesis up to 52 weeks post-transplant.
intervention type: Drug
intervention name: Valganciclovir
description: Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
arm group label: Cohort A: Partcipants who Received Valganciclovir
other name: Valcyte®
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
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country: Mexico
country: United States
responsible party type: Sponsor
mesh term: Cytomegalovirus Infections
mesh term: Valganciclovir
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 