<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/NCT01717768</url>
  </required_header>
  <id_info>
    <org_study_id>TT-002</org_study_id>
    <nct_id>NCT01717768</nct_id>
  </id_info>
  <brief_title>Oral Testosterone for the Treatment of Hypogonadism</brief_title>
  <official_title>A Phase 2, Randomized, Double-blind, Dose Response Study of Oral Testosterone in Subjects With Hypogonadism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TesoRx Pharma, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TesoRx Pharma, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Low testosterone is a condition that occurs when the body is unable to produce sufficient&#xD;
      quantities of testosterone. The medical name for low testosterone is hypogonadism.&#xD;
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of&#xD;
      energy and mood swings. The goal of testosterone replacement therapy is to return&#xD;
      testosterone levels to the normal range and relieve symptoms.&#xD;
&#xD;
      The purpose of this study is to evaluate the ability of TSX-002, which is testosterone&#xD;
      provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within&#xD;
      the normal range in hypogonadal men. This will be determined by blood sampling at specified&#xD;
      times during the study. The study is also intended to evaluate the tolerability of TSX-002,&#xD;
      which will be taken orally twice per day for 15 days. In addition, the study is intended to&#xD;
      determine a dosing regimen(s) that achieves testosterone levels within the normal range.&#xD;
      Related Outcome Measures will be reported for Parts 1, 2, and 4.&#xD;
&#xD;
      A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on&#xD;
      the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported&#xD;
      for Part 3.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002</measure>
    <time_frame>15 days</time_frame>
    <description>Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax &gt; 2500 ng/dL After 15 Days of BID Treatment</measure>
    <time_frame>15 days</time_frame>
    <description>Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cavg 0-24 Hrs (ng/dL) After 120 mg Dose</measure>
    <time_frame>24 hrs</time_frame>
    <description>PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.</description>
  </other_outcome>
  <other_outcome>
    <measure>AUC 0-24 Hrs After 120 mg Dose of TSX-002</measure>
    <time_frame>24 hrs</time_frame>
    <description>AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.</description>
  </other_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Hypogonadism</condition>
  <arm_group>
    <arm_group_label>Part 1: 120 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: 240 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: 120 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3: A-B-C 120 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3: B-C-A 120 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3: C-A-B 120 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4 Cohort 1: 60 mg BID/ 60 mg TID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4 Cohort 2: 90 mg BID/ 90 mg TID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4 Cohort 3: 180 mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral TSX-002 180 mg once daily (QD) for 15 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4 Cohort 4: 120 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral TSX-002 120 mg BID for 15 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TSX-002</intervention_name>
    <description>TSX-002 are capsules with testosterone as the active ingredient.</description>
    <arm_group_label>Part 1: 120 mg BID</arm_group_label>
    <arm_group_label>Part 1: 240 mg BID</arm_group_label>
    <arm_group_label>Part 2: 120 mg BID</arm_group_label>
    <arm_group_label>Part 3: A-B-C 120 mg QD</arm_group_label>
    <arm_group_label>Part 3: B-C-A 120 mg QD</arm_group_label>
    <arm_group_label>Part 3: C-A-B 120 mg QD</arm_group_label>
    <arm_group_label>Part 4 Cohort 1: 60 mg BID/ 60 mg TID</arm_group_label>
    <arm_group_label>Part 4 Cohort 2: 90 mg BID/ 90 mg TID</arm_group_label>
    <arm_group_label>Part 4 Cohort 3: 180 mg QD</arm_group_label>
    <arm_group_label>Part 4 Cohort 4: 120 mg BID</arm_group_label>
    <other_name>Testosterone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Prior documentation of a diagnosis of hypogonadism as evidenced by a screening serum&#xD;
             testosterone &lt; 300 ng/dL (based on the average of 2 morning samples taken at least 1&#xD;
             week apart)&#xD;
&#xD;
          -  Men over the age of 18 years with a body mass index (BMI) &lt; 39.0 kg/m2 and weighing ≥&#xD;
             55 kg&#xD;
&#xD;
          -  Hemoglobin levels at screening and baseline &gt; 12.5 g/dL&#xD;
&#xD;
          -  Testosterone treatment not contraindicated&#xD;
&#xD;
          -  No evidence of suspected reversible hypogonadism&#xD;
&#xD;
          -  Willing to abstain from current treatment for hypogonadism in accordance with approved&#xD;
             labeling to facilitate an appropriate washout period before study participation (for&#xD;
             nondepot formulations of testosterone only)&#xD;
&#xD;
          -  Understands the requirements of the study and voluntarily consents to participate in&#xD;
             the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Kowalczyk, DO, FACOS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Urology Group of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology Group of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>August 14, 2015</results_first_submitted>
  <results_first_submitted_qc>December 14, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 15, 2015</results_first_posted>
  <last_update_submitted>December 14, 2015</last_update_submitted>
  <last_update_submitted_qc>December 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypogonadism</keyword>
  <keyword>Gonadal Disorders</keyword>
  <keyword>Endocrine System Diseases</keyword>
  <keyword>Testosterone</keyword>
  <keyword>Testosterone enanthate</keyword>
  <keyword>Testosterone undecanoate</keyword>
  <keyword>Testosterone 17 beta-cypionate</keyword>
  <keyword>Methyltestosterone</keyword>
  <keyword>Androgens</keyword>
  <keyword>Hormones</keyword>
  <keyword>Hormones, Hormone Substitutes, and Hormone Antagonists</keyword>
  <keyword>Physiological Effects of Drugs</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Therapeutic Uses</keyword>
  <keyword>Anabolic Agents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypogonadism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Testosterone</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>130 subjects were recruited at 1 center in the US from October 2012 to May 2014. The study was designed with 4 parts, including 9 different dosages of the investigational drug.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: 120 mg BID</title>
          <description>Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P2">
          <title>Part 1: 240 mg BID</title>
          <description>Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P3">
          <title>Part 2: 120 mg BID</title>
          <description>Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P4">
          <title>Part 3: A-B-C 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P5">
          <title>Part 3: B-C-A 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
        </group>
        <group group_id="P6">
          <title>Part 3: C-A-B 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
        </group>
        <group group_id="P7">
          <title>Part 4 Cohort 1: 60 mg BID</title>
          <description>Oral TSX-002 60 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P8">
          <title>Part 4 Cohort 1: 60 mg TID</title>
          <description>Oral TSX-002 60 mg TID for 15 days&#xD;
TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P9">
          <title>Part 4 Cohort 2: 90 mg BID</title>
          <description>Oral TSX-002 90 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P10">
          <title>Part 4 Cohort 2: 90 mg TID</title>
          <description>Oral TSX-002 90 mg TID for 15 days</description>
        </group>
        <group group_id="P11">
          <title>Part 4 Cohort 3: 180 mg QD</title>
          <description>Oral TSX-002 180 mg once daily (QD) for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="P12">
          <title>Part 4 Cohort 4: 120 mg BID</title>
          <description>Oral TSX-002 120 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1 (Duration of 15 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </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="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2 (Duration of 15 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 3 - Treatment 1 (Duration of 1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 3 - Treatment 2 (Duration of 1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 3 - Treatment 3 (Duration of 1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Part 4-Treatment 1 (Duration of 15 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="17"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="16"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="16"/>
                <participants group_id="P12" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="17"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="16"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="16"/>
                <participants group_id="P12" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 4-Treatment 2 (Duration of 15 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="17"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="16"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="15"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="15"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
                <participants group_id="P11" count="0"/>
                <participants group_id="P12" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1: 120 mg BID</title>
          <description>Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B2">
          <title>Part 1: 240 mg BID</title>
          <description>Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B3">
          <title>Part 2: 120 mg BID</title>
          <description>Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B4">
          <title>Part 3: A-B-C 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B5">
          <title>Part 3: B-C-A 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B6">
          <title>Part 3: C-A-B 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B7">
          <title>Part 4 Cohort 1: 60 mg BID/ 60 mg TID</title>
          <description>Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B8">
          <title>Part 4 Cohort 2: 90 mg BID/ 90 mg TID</title>
          <description>Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B9">
          <title>Part 4 Cohort 3: 180 mg QD</title>
          <description>Oral TSX-002 180 mg once daily (QD) for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B10">
          <title>Part 4 Cohort 4: 120 mg BID</title>
          <description>Oral TSX-002 120 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="B11">
          <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="17"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="17"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="5"/>
            <count group_id="B6" value="5"/>
            <count group_id="B7" value="17"/>
            <count group_id="B8" value="16"/>
            <count group_id="B9" value="16"/>
            <count group_id="B10" value="16"/>
            <count group_id="B11" value="130"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="9"/>
                    <measurement group_id="B10" value="5"/>
                    <measurement group_id="B11" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50-64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="7"/>
                    <measurement group_id="B10" value="9"/>
                    <measurement group_id="B11" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65-74 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="2"/>
                    <measurement group_id="B11" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>75 years or older</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="16"/>
                    <measurement group_id="B10" value="16"/>
                    <measurement group_id="B11" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="1"/>
                    <measurement group_id="B11" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="13"/>
                    <measurement group_id="B10" value="12"/>
                    <measurement group_id="B11" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="17"/>
                    <measurement group_id="B8" value="16"/>
                    <measurement group_id="B9" value="16"/>
                    <measurement group_id="B10" value="16"/>
                    <measurement group_id="B11" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002</title>
        <description>Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.</description>
        <time_frame>15 days</time_frame>
        <population>All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: 120 mg BID</title>
            <description>Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: 240 mg BID</title>
            <description>Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: 120 mg BID</title>
            <description>Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O4">
            <title>Part 4 Cohort 1: 60 mg BID</title>
            <description>Oral TSX-002 60 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O5">
            <title>Part 4 Cohort 1: 60 mg TID</title>
            <description>Oral TSX-002 60 mg three times daily (TID) for 15 days</description>
          </group>
          <group group_id="O6">
            <title>Part 4 Cohort 2: 90 mg BID</title>
            <description>Oral TSX-002 90 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O7">
            <title>Part 4 Cohort 2: 90 mg TID</title>
            <description>Oral TSX-002 90 mg TID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O8">
            <title>Part 4 Cohort 3: 180 mg QD</title>
            <description>Oral TSX-002 180 mg once daily (QD) for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O9">
            <title>Part 4 Cohort 4: 120 mg BID</title>
            <description>Oral TSX-002 120 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002</title>
          <description>Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.</description>
          <population>All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.</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="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="16"/>
                <count group_id="O8" value="16"/>
                <count group_id="O9" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="41"/>
                    <measurement group_id="O5" value="53"/>
                    <measurement group_id="O6" value="19"/>
                    <measurement group_id="O7" value="20"/>
                    <measurement group_id="O8" value="31"/>
                    <measurement group_id="O9" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax &gt; 2500 ng/dL After 15 Days of BID Treatment</title>
        <description>Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.</description>
        <time_frame>15 days</time_frame>
        <population>All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: 120 mg BID</title>
            <description>Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O2">
            <title>Part 1: 240 mg BID</title>
            <description>Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O3">
            <title>Part 2: 120 mg BID</title>
            <description>Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O4">
            <title>Part 4 Cohort 1: 60 mg BID</title>
            <description>Oral TSX-002 60 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O5">
            <title>Part 4 Cohort 1: 60 mg TID</title>
            <description>Oral TSX-002 60 mg three times daily (TID) for 15 days</description>
          </group>
          <group group_id="O6">
            <title>Part 4 Cohort 2: 90 mg BID</title>
            <description>Oral TSX-002 90 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O7">
            <title>Part 4 Cohort 2: 90 mg TID</title>
            <description>Oral TSX-002 90 mg TID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O8">
            <title>Part 4 Cohort 3: 180 mg QD</title>
            <description>Oral TSX-002 180 mg once daily (QD) for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
          <group group_id="O9">
            <title>Part 4 Cohort 4: 120 mg BID</title>
            <description>Oral TSX-002 120 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax &gt; 2500 ng/dL After 15 Days of BID Treatment</title>
          <description>Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.</description>
          <population>All efficacy analyses were conducted based on the modified intent-to-treat (MITT) analysis population, comprised of all randomized subjects who receive at least 1 dose of study drug and have at least 1 post-baseline measurement of total serum testosterone.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="16"/>
                <count group_id="O8" value="16"/>
                <count group_id="O9" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of subjects with Cmax ≤ 1500 ng/dL afte</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="94.1"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                    <measurement group_id="O6" value="100"/>
                    <measurement group_id="O7" value="100"/>
                    <measurement group_id="O8" value="100"/>
                    <measurement group_id="O9" value="93.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of subjects with Cmax ≥ 1800 and ≤ 2500</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="6.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of subjects with Cmax &gt; 2500 ng/dL afte</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Cavg 0-24 Hrs (ng/dL) After 120 mg Dose</title>
        <description>PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.</description>
        <time_frame>24 hrs</time_frame>
        <population>All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3:120 mg QD Treatment A</title>
            <description>Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
          </group>
          <group group_id="O2">
            <title>Part 3:120 mg QD Treatment B</title>
            <description>Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
          </group>
          <group group_id="O3">
            <title>Part 3:120 mg QD Treatment C</title>
            <description>Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
          </group>
        </group_list>
        <measure>
          <title>Cavg 0-24 Hrs (ng/dL) After 120 mg Dose</title>
          <description>PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.</description>
          <population>All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).</population>
          <units>ng/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296" spread="108"/>
                    <measurement group_id="O2" value="297" spread="75"/>
                    <measurement group_id="O3" value="273" spread="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>AUC 0-24 Hrs After 120 mg Dose of TSX-002</title>
        <description>AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.</description>
        <time_frame>24 hrs</time_frame>
        <population>All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3:120 mg QD Treatment A</title>
            <description>Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
          </group>
          <group group_id="O2">
            <title>Part 3:120 mg QD Treatment B</title>
            <description>Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
          </group>
          <group group_id="O3">
            <title>Part 3:120 mg QD Treatment C</title>
            <description>Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.</description>
          </group>
        </group_list>
        <measure>
          <title>AUC 0-24 Hrs After 120 mg Dose of TSX-002</title>
          <description>AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.</description>
          <population>All subjects that received 120 mg TSX-002 under defined Treatment conditions (timing of high-calorie, high-fat meal).</population>
          <units>hr×ng/dL</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1941" spread="1198"/>
                    <measurement group_id="O2" value="2117" spread="1351"/>
                    <measurement group_id="O3" value="1516" spread="1217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The adverse events presented were collected from start of drug treatment to discontinuation or completion of study participation.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part 1: 120 mg BID</title>
          <description>Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E2">
          <title>Part 1: 240 mg BID</title>
          <description>Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E3">
          <title>Part 2: 120 mg BID</title>
          <description>Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E4">
          <title>Part 3: A-B-C 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E5">
          <title>Part 3: B-C-A 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E6">
          <title>Part 3: C-A-B 120 mg QD</title>
          <description>Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.&#xD;
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E7">
          <title>Part 4 Cohort 1: 60 mg BID</title>
          <description>Oral TSX-002 60 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E8">
          <title>Part 4 Cohort 1: 60 mg TID</title>
          <description>Oral TSX-002 60 mg TID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E9">
          <title>Part 4 Cohort 2: 90 mg BID</title>
          <description>Oral TSX-002 90 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E10">
          <title>Part 4 Cohort 2: 90 mg TID</title>
          <description>Oral TSX-002 90 mg TID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E11">
          <title>Part 4 Cohort 3: 180 mg QD</title>
          <description>Oral TSX-002 180 mg once daily (QD) for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
        <group group_id="E12">
          <title>Part 4 Cohort 4: 120 mg BID</title>
          <description>Oral TSX-002 120 mg BID for 15 days&#xD;
TSX-002: TSX-002 are capsules with testosterone as the active ingredient.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E11" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E12" subjects_affected="3" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Catheter site phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sluggishness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E12" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Psychomotor hyperactivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Anger</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urine flow decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E10" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E11" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E12" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </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>Restriction Description: At 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment and provide written permission prior to publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Oefelein, MD, Chief Medical Officer</name_or_title>
      <organization>TesoRx Pharma LLC</organization>
      <phone>909-595-0500 ext 104</phone>
      <email>karl@tesorx.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/NCT01717768
org study id: TT-002
nct id: NCT01717768
lead sponsor: 
has dmc: No
Low testosterone is a condition that occurs when the body is unable to produce sufficient
      quantities of testosterone. The medical name for low testosterone is hypogonadism.
      Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of
      energy and mood swings. The goal of testosterone replacement therapy is to return
      testosterone levels to the normal range and relieve symptoms.

      The purpose of this study is to evaluate the ability of TSX-002, which is testosterone
      provided in easy to swallow capsules, to maintain serum (blood) testosterone levels within
      the normal range in hypogonadal men. This will be determined by blood sampling at specified
      times during the study. The study is also intended to evaluate the tolerability of TSX-002,
      which will be taken orally twice per day for 15 days. In addition, the study is intended to
      determine a dosing regimen(s) that achieves testosterone levels within the normal range.
      Related Outcome Measures will be reported for Parts 1, 2, and 4.

      A portion of the study (Part 3) to also assess the effect of a high-calorie, high-fat meal on
      the single dose pharmacokinetic exposure of TSX-002. Related outcome measures to be reported
      for Part 3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Subjects Achieving a 24 Hour Average Total Serum Testosterone Concentration (Cavg,0-24h) in the Range of 300 to 1050 ng/dL After 15 Days of Treatment With TSX-002
time frame: 15 days
description: Percentage of subjects achieving a 24-hour average total serum testosterone concentration (Cavg,0-24h) in the range of 300 to 1050 ng/dL after 15 days of treatment with TSX-002. PK samples taken at 0 ,2 ,4, 5 ,6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8 ,12, 13, 14, 15, 16, 17, 18, 20, 24 hours post-dose after 15 days of treatment for Part 4.
measure: Percentage of Subjects With Cmax ≤ 1500 ng/dL After 15 Days of Treatment 2. Percentage of Subjects With Cmax ≥ 1800 and ≤ 2500 ng/dL After 15 Days of BID Treatment 3. Percentage of Subjects With Cmax > 2500 ng/dL After 15 Days of BID Treatment
time frame: 15 days
description: Cmax. PK samples taken at 0, 2, 4, 5, 6, 7, 9, 12, 14, 16, 17, 18, 21, 24 hours post-dose after 15 days of treatment for Part 1. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 16, 17, 18, 19, 20, 21, 22, 24 hours post-dose after 15 days of treatment for Part 2. PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 12, 13, 14, 15, 16, 17,18, 20, 24 hours post-dose after 15 days of treatment for Part 4.
measure: Cavg 0-24 Hrs (ng/dL) After 120 mg Dose
time frame: 24 hrs
description: PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3. Mean of Cavg values from all time points for 14 subjects.
measure: AUC 0-24 Hrs After 120 mg Dose of TSX-002
time frame: 24 hrs
description: AUC 0-24 hrs with PK samples taken at 0, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24 hours post-dose after 1 day of treatment for Part 3.
arm group label: Part 1: 120 mg BID
arm group type: Experimental
description: Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
arm group label: Part 1: 240 mg BID
arm group type: Experimental
description: Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days
arm group label: Part 2: 120 mg BID
arm group type: Experimental
description: Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days
arm group label: Part 3: A-B-C 120 mg QD
arm group type: Experimental
description: Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
arm group label: Part 3: B-C-A 120 mg QD
arm group type: Experimental
description: Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
arm group label: Part 3: C-A-B 120 mg QD
arm group type: Experimental
description: Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.
Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
arm group label: Part 4 Cohort 1: 60 mg BID/ 60 mg TID
arm group type: Experimental
description: Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days
arm group label: Part 4 Cohort 2: 90 mg BID/ 90 mg TID
arm group type: Experimental
description: Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days
arm group label: Part 4 Cohort 3: 180 mg QD
arm group type: Experimental
description: Oral TSX-002 180 mg once daily (QD) for 15 days
arm group label: Part 4 Cohort 4: 120 mg BID
arm group type: Experimental
description: Oral TSX-002 120 mg BID for 15 days
intervention type: Drug
intervention name: TSX-002
description: TSX-002 are capsules with testosterone as the active ingredient.
arm group label: Part 1: 120 mg BID
arm group label: Part 1: 240 mg BID
arm group label: Part 2: 120 mg BID
arm group label: Part 3: A-B-C 120 mg QD
arm group label: Part 3: B-C-A 120 mg QD
arm group label: Part 3: C-A-B 120 mg QD
arm group label: Part 4 Cohort 1: 60 mg BID/ 60 mg TID
arm group label: Part 4 Cohort 2: 90 mg BID/ 90 mg TID
arm group label: Part 4 Cohort 3: 180 mg QD
arm group label: Part 4 Cohort 4: 120 mg BID
other name: Testosterone
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John Kowalczyk, DO, FACOS
role: Principal Investigator
affiliation: Urology Group of Southern California
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypogonadism
mesh term: Testosterone
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 